Trial Outcomes & Findings for Hsp90 Inhibitor AUY922 and Erlotinib Hydrochloride in Treating Patients With Stage IIIB-IV Non-Small Cell Lung Cancer (NCT NCT01259089)
NCT ID: NCT01259089
Last Updated: 2019-09-11
Results Overview
To determine the maximally tolerated dose (MTD), and recommended phase II dose of AUY922 when given in combination with erlotinib for patients with acquired resistance to erlotinib. (Phase I) Escalation of dose will be in a 3+3 design. If no dose limiting toxicities (DLTs) are seen in 3 patients enrolled at that dose level, then dose will be escalated to the next dose level and the next 3 patients will be enrolled at that dose. Alternatively, if 1 DLT is seen in 3 patients at that dose level, 3 more patients will be added at that same dose level. If 1 DLT is seen in 6 patients at that dose level, MTD will be determined to be at that dose. If more than 1 DLT is seen at that dose level, then the prior lower dose level will be the considered the MTD. DLT is defined as any of the following related to the investigational agent: Death and grade 3 and 4 specific hematological and non-hematological toxicities defined in the protocol.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
38 participants
Primary outcome timeframe
During the first 4 weeks of treatment for each patient.
Results posted on
2019-09-11
Participant Flow
The study opened for accrual on March 28, 2011 with an accrual goal of up to 30 patients in phase I and 25 patients in phase II. 18 patients were enrolled treated in phase I and 19 patients treated in phase II. The study was closed permanently on May 6, 2013.
Participant milestones
| Measure |
Cohort 1 - 25 mg/m2 AUY922+75 mg Daily Erlotinib
Patients receive Hsp90 inhibitor AUY922 IV over 1 hour once weekly and 75mg oral erlotinib hydrochloride once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
erlotinib hydrochloride: Given orally
Hsp90 inhibitor AUY922: Given IV
laboratory biomarker analysis: Correlative studies
needle biopsy: Undergo image-guided needle biopsy (correlative studies)
mutation analysis: Correlative studies
pharmacological study: Correlative studies
|
Cohort 2 - 25 mg/m2AUY922+150 mg Daily Erlotinib
Patients receive Hsp90 inhibitor AUY922 IV over 1 hour once weekly and oral erlotinib hydrochloride once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
erlotinib hydrochloride: Given orally
Hsp90 inhibitor AUY922: Given IV
laboratory biomarker analysis: Correlative studies
needle biopsy: Undergo image-guided needle biopsy (correlative studies)
mutation analysis: Correlative studies
pharmacological study: Correlative studies
|
Cohort 3 - 37.5 mg/m2 AUY922+150 mg Daily Erlotinib
Patients receive Hsp90 inhibitor AUY922 IV over 1 hour once weekly and 75mg oral erlotinib hydrochloride once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
erlotinib hydrochloride: Given orally
Hsp90 inhibitor AUY922: Given IV
laboratory biomarker analysis: Correlative studies
needle biopsy: Undergo image-guided needle biopsy (correlative studies)
mutation analysis: Correlative studies
pharmacological study: Correlative studies
|
Cohort 4 - 55 mg/m2 AUY922+150 mg Daily Erlotinib
Patients receive Hsp90 inhibitor AUY922 IV over 1 hour once weekly and 75mg oral erlotinib hydrochloride once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
erlotinib hydrochloride: Given orally
Hsp90 inhibitor AUY922: Given IV
laboratory biomarker analysis: Correlative studies
needle biopsy: Undergo image-guided needle biopsy (correlative studies)
mutation analysis: Correlative studies
pharmacological study: Correlative studies
|
Cohort 5 - 70 mg/m2 AUY922+150 mg Daily Erlotinib
Patients receive Hsp90 inhibitor AUY922 IV over 1 hour once weekly and 75mg oral erlotinib hydrochloride once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
erlotinib hydrochloride: Given orally
Hsp90 inhibitor AUY922: Given IV
laboratory biomarker analysis: Correlative studies
needle biopsy: Undergo image-guided needle biopsy (correlative studies)
mutation analysis: Correlative studies
pharmacological study: Correlative studies
|
Phase II- 70 mg/m2 AUY922+150 mg Daily Erlotinib
Patients receive Hsp90 inhibitor AUY922 IV over 1 hour once weekly and 75mg oral erlotinib hydrochloride once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
erlotinib hydrochloride: Given orally
Hsp90 inhibitor AUY922: Given IV
laboratory biomarker analysis: Correlative studies
needle biopsy: Undergo image-guided needle biopsy (correlative studies)
mutation analysis: Correlative studies
pharmacological study: Correlative studies
|
|---|---|---|---|---|---|---|
|
Reached First Response at 4 Weeks
STARTED
|
3
|
3
|
3
|
3
|
6
|
20
|
|
Reached First Response at 4 Weeks
Started Treatment on Study
|
3
|
3
|
3
|
3
|
6
|
19
|
|
Reached First Response at 4 Weeks
Completed 4 Weeks of Treatment
|
3
|
3
|
3
|
3
|
6
|
18
|
|
Reached First Response at 4 Weeks
COMPLETED
|
3
|
3
|
3
|
3
|
6
|
18
|
|
Reached First Response at 4 Weeks
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
2
|
|
Confirmed Response at 8 Weeks
STARTED
|
3
|
3
|
3
|
3
|
6
|
18
|
|
Confirmed Response at 8 Weeks
COMPLETED
|
3
|
3
|
2
|
2
|
2
|
8
|
|
Confirmed Response at 8 Weeks
NOT COMPLETED
|
0
|
0
|
1
|
1
|
4
|
10
|
|
Continued Treatment After 8 Weeks
STARTED
|
3
|
3
|
2
|
2
|
2
|
8
|
|
Continued Treatment After 8 Weeks
COMPLETED
|
1
|
2
|
1
|
1
|
0
|
7
|
|
Continued Treatment After 8 Weeks
NOT COMPLETED
|
2
|
1
|
1
|
1
|
2
|
1
|
|
Survival Follow up for Two Years
STARTED
|
3
|
3
|
3
|
3
|
6
|
19
|
|
Survival Follow up for Two Years
COMPLETED
|
0
|
1
|
1
|
0
|
0
|
0
|
|
Survival Follow up for Two Years
NOT COMPLETED
|
3
|
2
|
2
|
3
|
6
|
19
|
Reasons for withdrawal
| Measure |
Cohort 1 - 25 mg/m2 AUY922+75 mg Daily Erlotinib
Patients receive Hsp90 inhibitor AUY922 IV over 1 hour once weekly and 75mg oral erlotinib hydrochloride once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
erlotinib hydrochloride: Given orally
Hsp90 inhibitor AUY922: Given IV
laboratory biomarker analysis: Correlative studies
needle biopsy: Undergo image-guided needle biopsy (correlative studies)
mutation analysis: Correlative studies
pharmacological study: Correlative studies
|
Cohort 2 - 25 mg/m2AUY922+150 mg Daily Erlotinib
Patients receive Hsp90 inhibitor AUY922 IV over 1 hour once weekly and oral erlotinib hydrochloride once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
erlotinib hydrochloride: Given orally
Hsp90 inhibitor AUY922: Given IV
laboratory biomarker analysis: Correlative studies
needle biopsy: Undergo image-guided needle biopsy (correlative studies)
mutation analysis: Correlative studies
pharmacological study: Correlative studies
|
Cohort 3 - 37.5 mg/m2 AUY922+150 mg Daily Erlotinib
Patients receive Hsp90 inhibitor AUY922 IV over 1 hour once weekly and 75mg oral erlotinib hydrochloride once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
erlotinib hydrochloride: Given orally
Hsp90 inhibitor AUY922: Given IV
laboratory biomarker analysis: Correlative studies
needle biopsy: Undergo image-guided needle biopsy (correlative studies)
mutation analysis: Correlative studies
pharmacological study: Correlative studies
|
Cohort 4 - 55 mg/m2 AUY922+150 mg Daily Erlotinib
Patients receive Hsp90 inhibitor AUY922 IV over 1 hour once weekly and 75mg oral erlotinib hydrochloride once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
erlotinib hydrochloride: Given orally
Hsp90 inhibitor AUY922: Given IV
laboratory biomarker analysis: Correlative studies
needle biopsy: Undergo image-guided needle biopsy (correlative studies)
mutation analysis: Correlative studies
pharmacological study: Correlative studies
|
Cohort 5 - 70 mg/m2 AUY922+150 mg Daily Erlotinib
Patients receive Hsp90 inhibitor AUY922 IV over 1 hour once weekly and 75mg oral erlotinib hydrochloride once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
erlotinib hydrochloride: Given orally
Hsp90 inhibitor AUY922: Given IV
laboratory biomarker analysis: Correlative studies
needle biopsy: Undergo image-guided needle biopsy (correlative studies)
mutation analysis: Correlative studies
pharmacological study: Correlative studies
|
Phase II- 70 mg/m2 AUY922+150 mg Daily Erlotinib
Patients receive Hsp90 inhibitor AUY922 IV over 1 hour once weekly and 75mg oral erlotinib hydrochloride once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
erlotinib hydrochloride: Given orally
Hsp90 inhibitor AUY922: Given IV
laboratory biomarker analysis: Correlative studies
needle biopsy: Undergo image-guided needle biopsy (correlative studies)
mutation analysis: Correlative studies
pharmacological study: Correlative studies
|
|---|---|---|---|---|---|---|
|
Reached First Response at 4 Weeks
Patient not treated on study
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Reached First Response at 4 Weeks
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Confirmed Response at 8 Weeks
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Confirmed Response at 8 Weeks
Adverse Event
|
0
|
0
|
0
|
0
|
1
|
2
|
|
Confirmed Response at 8 Weeks
Progressive disease
|
0
|
0
|
1
|
1
|
3
|
7
|
|
Continued Treatment After 8 Weeks
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Continued Treatment After 8 Weeks
Adverse Event
|
0
|
0
|
0
|
0
|
2
|
1
|
|
Continued Treatment After 8 Weeks
Progressive disease
|
1
|
1
|
1
|
1
|
0
|
0
|
|
Survival Follow up for Two Years
Death
|
3
|
2
|
2
|
3
|
6
|
13
|
|
Survival Follow up for Two Years
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
2
|
|
Survival Follow up for Two Years
stopped being followed as study closed
|
0
|
0
|
0
|
0
|
0
|
4
|
Baseline Characteristics
Hsp90 Inhibitor AUY922 and Erlotinib Hydrochloride in Treating Patients With Stage IIIB-IV Non-Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Arm I
n=38 Participants
Patients receive Hsp90 inhibitor AUY922 IV over 1 hour once weekly and oral erlotinib hydrochloride once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
erlotinib hydrochloride: Given orally
Hsp90 inhibitor AUY922: Given IV
laboratory biomarker analysis: Correlative studies
needle biopsy: Undergo image-guided needle biopsy (correlative studies)
mutation analysis: Correlative studies
pharmacological study: Correlative studies
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
25 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
37 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
38 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: During the first 4 weeks of treatment for each patient.To determine the maximally tolerated dose (MTD), and recommended phase II dose of AUY922 when given in combination with erlotinib for patients with acquired resistance to erlotinib. (Phase I) Escalation of dose will be in a 3+3 design. If no dose limiting toxicities (DLTs) are seen in 3 patients enrolled at that dose level, then dose will be escalated to the next dose level and the next 3 patients will be enrolled at that dose. Alternatively, if 1 DLT is seen in 3 patients at that dose level, 3 more patients will be added at that same dose level. If 1 DLT is seen in 6 patients at that dose level, MTD will be determined to be at that dose. If more than 1 DLT is seen at that dose level, then the prior lower dose level will be the considered the MTD. DLT is defined as any of the following related to the investigational agent: Death and grade 3 and 4 specific hematological and non-hematological toxicities defined in the protocol.
Outcome measures
| Measure |
Cohort 1 - 25 mg/m2 AUY922+75 mg Daily Erlotinib
n=3 Participants
Patients receive Hsp90 inhibitor AUY922 IV over 1 hour once weekly and oral erlotinib hydrochloride once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
erlotinib hydrochloride: Given orally
Hsp90 inhibitor AUY922: Given IV
laboratory biomarker analysis: Correlative studies
needle biopsy: Undergo image-guided needle biopsy (correlative studies)
mutation analysis: Correlative studies
pharmacological study: Correlative studies
|
Cohort 2 - 25 mg/m2AUY922+150 mg Daily Erlotinib
n=3 Participants
Patients receive Hsp90 inhibitor AUY922 IV over 1 hour once weekly and oral erlotinib hydrochloride once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
erlotinib hydrochloride: Given orally
Hsp90 inhibitor AUY922: Given IV
laboratory biomarker analysis: Correlative studies
needle biopsy: Undergo image-guided needle biopsy (correlative studies)
mutation analysis: Correlative studies
pharmacological study: Correlative studies
|
Cohort 3 - 37.5 mg/m2 AUY922+150 mg Daily Erlotinib
n=3 Participants
Patients receive Hsp90 inhibitor AUY922 IV over 1 hour once weekly and oral erlotinib hydrochloride once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
erlotinib hydrochloride: Given orally
Hsp90 inhibitor AUY922: Given IV
laboratory biomarker analysis: Correlative studies
needle biopsy: Undergo image-guided needle biopsy (correlative studies)
mutation analysis: Correlative studies
pharmacological study: Correlative studies
|
Cohort 4 - 55 mg/m2 AUY922+150 mg Daily Erlotinib
n=3 Participants
Patients receive Hsp90 inhibitor AUY922 IV over 1 hour once weekly and oral erlotinib hydrochloride once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
erlotinib hydrochloride: Given orally
Hsp90 inhibitor AUY922: Given IV
laboratory biomarker analysis: Correlative studies
needle biopsy: Undergo image-guided needle biopsy (correlative studies)
mutation analysis: Correlative studies
pharmacological study: Correlative studies
|
Cohort 5 - 70 mg/m2 AUY922+150 mg Daily Erlotinib
n=6 Participants
Patients receive Hsp90 inhibitor AUY922 IV over 1 hour once weekly and oral erlotinib hydrochloride once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
erlotinib hydrochloride: Given orally
Hsp90 inhibitor AUY922: Given IV
laboratory biomarker analysis: Correlative studies
needle biopsy: Undergo image-guided needle biopsy (correlative studies)
mutation analysis: Correlative studies
pharmacological study: Correlative studies
|
|---|---|---|---|---|---|
|
Maximally Tolerated Dose (MTD) of AUY922 and Erlotinib Treatment Combination (Phase I)
|
0 Number of DLTs seen
|
0 Number of DLTs seen
|
0 Number of DLTs seen
|
0 Number of DLTs seen
|
1 Number of DLTs seen
|
PRIMARY outcome
Timeframe: At 8 weeks from treatment initiationPopulation: All patients that were treated at the MTD dose of 70mg/m2 AUG922 IV were evaluable for this outcome measure (This includes patients treated in cohort 5 of phase I and all patients treated in phase II of the study)
Overall response rate (ORR) will be measured per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT scan or MRI: Complete response (CR) defined as disappearance of all target lesions. Partial Response (PR), defined as \>=30% decrease in the sum of the longest diameter of target lesions. Stable Disease (SD) defined as neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. Progressive Disease (PD) defined as having at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions
Outcome measures
| Measure |
Cohort 1 - 25 mg/m2 AUY922+75 mg Daily Erlotinib
n=25 Participants
Patients receive Hsp90 inhibitor AUY922 IV over 1 hour once weekly and oral erlotinib hydrochloride once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
erlotinib hydrochloride: Given orally
Hsp90 inhibitor AUY922: Given IV
laboratory biomarker analysis: Correlative studies
needle biopsy: Undergo image-guided needle biopsy (correlative studies)
mutation analysis: Correlative studies
pharmacological study: Correlative studies
|
Cohort 2 - 25 mg/m2AUY922+150 mg Daily Erlotinib
Patients receive Hsp90 inhibitor AUY922 IV over 1 hour once weekly and oral erlotinib hydrochloride once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
erlotinib hydrochloride: Given orally
Hsp90 inhibitor AUY922: Given IV
laboratory biomarker analysis: Correlative studies
needle biopsy: Undergo image-guided needle biopsy (correlative studies)
mutation analysis: Correlative studies
pharmacological study: Correlative studies
|
Cohort 3 - 37.5 mg/m2 AUY922+150 mg Daily Erlotinib
Patients receive Hsp90 inhibitor AUY922 IV over 1 hour once weekly and oral erlotinib hydrochloride once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
erlotinib hydrochloride: Given orally
Hsp90 inhibitor AUY922: Given IV
laboratory biomarker analysis: Correlative studies
needle biopsy: Undergo image-guided needle biopsy (correlative studies)
mutation analysis: Correlative studies
pharmacological study: Correlative studies
|
Cohort 4 - 55 mg/m2 AUY922+150 mg Daily Erlotinib
Patients receive Hsp90 inhibitor AUY922 IV over 1 hour once weekly and oral erlotinib hydrochloride once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
erlotinib hydrochloride: Given orally
Hsp90 inhibitor AUY922: Given IV
laboratory biomarker analysis: Correlative studies
needle biopsy: Undergo image-guided needle biopsy (correlative studies)
mutation analysis: Correlative studies
pharmacological study: Correlative studies
|
Cohort 5 - 70 mg/m2 AUY922+150 mg Daily Erlotinib
Patients receive Hsp90 inhibitor AUY922 IV over 1 hour once weekly and oral erlotinib hydrochloride once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
erlotinib hydrochloride: Given orally
Hsp90 inhibitor AUY922: Given IV
laboratory biomarker analysis: Correlative studies
needle biopsy: Undergo image-guided needle biopsy (correlative studies)
mutation analysis: Correlative studies
pharmacological study: Correlative studies
|
|---|---|---|---|---|---|
|
Overall Response Rate (ORR), Defined as Complete Response(CR) + Partial Response (PR) Using the Modified RECIST 1.1 Criteria for All Patients Treated at Dose of 70mg/m2 AUG922
|
4 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At weeks 1 through 4 and then every 2 weeks during treatment and 30 days post last treatment for up to 2 years and half yearsPopulation: Toxicity collected from all patients treated at the MTD of 70mg/m2 AUY922. 6 patients in phase I and 19 patients in phase II were treated at this dose.
To characterize the toxicity profile for the combination of erlotinib and AUY922. Toxicity data will be collected every week for the first 28 day cycle and then every two weeks during treatment and up to 28 days after the last treatment. Adverse events will be graded according to the National Cancer Institute's Common Toxicity Criteria for adverse events version 4.0 (CTCAE v4.0). In general adverse events (AEs) will be graded according to the following: Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE
Outcome measures
| Measure |
Cohort 1 - 25 mg/m2 AUY922+75 mg Daily Erlotinib
n=25 Participants
Patients receive Hsp90 inhibitor AUY922 IV over 1 hour once weekly and oral erlotinib hydrochloride once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
erlotinib hydrochloride: Given orally
Hsp90 inhibitor AUY922: Given IV
laboratory biomarker analysis: Correlative studies
needle biopsy: Undergo image-guided needle biopsy (correlative studies)
mutation analysis: Correlative studies
pharmacological study: Correlative studies
|
Cohort 2 - 25 mg/m2AUY922+150 mg Daily Erlotinib
Patients receive Hsp90 inhibitor AUY922 IV over 1 hour once weekly and oral erlotinib hydrochloride once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
erlotinib hydrochloride: Given orally
Hsp90 inhibitor AUY922: Given IV
laboratory biomarker analysis: Correlative studies
needle biopsy: Undergo image-guided needle biopsy (correlative studies)
mutation analysis: Correlative studies
pharmacological study: Correlative studies
|
Cohort 3 - 37.5 mg/m2 AUY922+150 mg Daily Erlotinib
Patients receive Hsp90 inhibitor AUY922 IV over 1 hour once weekly and oral erlotinib hydrochloride once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
erlotinib hydrochloride: Given orally
Hsp90 inhibitor AUY922: Given IV
laboratory biomarker analysis: Correlative studies
needle biopsy: Undergo image-guided needle biopsy (correlative studies)
mutation analysis: Correlative studies
pharmacological study: Correlative studies
|
Cohort 4 - 55 mg/m2 AUY922+150 mg Daily Erlotinib
Patients receive Hsp90 inhibitor AUY922 IV over 1 hour once weekly and oral erlotinib hydrochloride once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
erlotinib hydrochloride: Given orally
Hsp90 inhibitor AUY922: Given IV
laboratory biomarker analysis: Correlative studies
needle biopsy: Undergo image-guided needle biopsy (correlative studies)
mutation analysis: Correlative studies
pharmacological study: Correlative studies
|
Cohort 5 - 70 mg/m2 AUY922+150 mg Daily Erlotinib
Patients receive Hsp90 inhibitor AUY922 IV over 1 hour once weekly and oral erlotinib hydrochloride once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
erlotinib hydrochloride: Given orally
Hsp90 inhibitor AUY922: Given IV
laboratory biomarker analysis: Correlative studies
needle biopsy: Undergo image-guided needle biopsy (correlative studies)
mutation analysis: Correlative studies
pharmacological study: Correlative studies
|
|---|---|---|---|---|---|
|
Toxicity as Assessed by NCI CTCAE Version 4.00 When AUG922 Administered at Its MTD (Phase I and II)
Diarrhea
|
24 participants
|
—
|
—
|
—
|
—
|
|
Toxicity as Assessed by NCI CTCAE Version 4.00 When AUG922 Administered at Its MTD (Phase I and II)
Skin rash
|
16 participants
|
—
|
—
|
—
|
—
|
|
Toxicity as Assessed by NCI CTCAE Version 4.00 When AUG922 Administered at Its MTD (Phase I and II)
Hyperglycemia
|
23 participants
|
—
|
—
|
—
|
—
|
|
Toxicity as Assessed by NCI CTCAE Version 4.00 When AUG922 Administered at Its MTD (Phase I and II)
Night blindness
|
18 participants
|
—
|
—
|
—
|
—
|
|
Toxicity as Assessed by NCI CTCAE Version 4.00 When AUG922 Administered at Its MTD (Phase I and II)
Hypoalbuminemia
|
21 participants
|
—
|
—
|
—
|
—
|
|
Toxicity as Assessed by NCI CTCAE Version 4.00 When AUG922 Administered at Its MTD (Phase I and II)
Fatigue
|
11 participants
|
—
|
—
|
—
|
—
|
|
Toxicity as Assessed by NCI CTCAE Version 4.00 When AUG922 Administered at Its MTD (Phase I and II)
Elevated AST
|
17 participants
|
—
|
—
|
—
|
—
|
|
Toxicity as Assessed by NCI CTCAE Version 4.00 When AUG922 Administered at Its MTD (Phase I and II)
Nausea
|
9 participants
|
—
|
—
|
—
|
—
|
|
Toxicity as Assessed by NCI CTCAE Version 4.00 When AUG922 Administered at Its MTD (Phase I and II)
Hyponatremia
|
17 participants
|
—
|
—
|
—
|
—
|
|
Toxicity as Assessed by NCI CTCAE Version 4.00 When AUG922 Administered at Its MTD (Phase I and II)
Elevated ALT
|
14 participants
|
—
|
—
|
—
|
—
|
|
Toxicity as Assessed by NCI CTCAE Version 4.00 When AUG922 Administered at Its MTD (Phase I and II)
Visual complaints
|
10 participants
|
—
|
—
|
—
|
—
|
|
Toxicity as Assessed by NCI CTCAE Version 4.00 When AUG922 Administered at Its MTD (Phase I and II)
Vomiting
|
8 participants
|
—
|
—
|
—
|
—
|
|
Toxicity as Assessed by NCI CTCAE Version 4.00 When AUG922 Administered at Its MTD (Phase I and II)
Elevated APL
|
10 participants
|
—
|
—
|
—
|
—
|
|
Toxicity as Assessed by NCI CTCAE Version 4.00 When AUG922 Administered at Its MTD (Phase I and II)
Decreased leukocytes
|
10 participants
|
—
|
—
|
—
|
—
|
|
Toxicity as Assessed by NCI CTCAE Version 4.00 When AUG922 Administered at Its MTD (Phase I and II)
Hypokalemia
|
10 participants
|
—
|
—
|
—
|
—
|
|
Toxicity as Assessed by NCI CTCAE Version 4.00 When AUG922 Administered at Its MTD (Phase I and II)
Pruritis/dry skin
|
5 participants
|
—
|
—
|
—
|
—
|
|
Toxicity as Assessed by NCI CTCAE Version 4.00 When AUG922 Administered at Its MTD (Phase I and II)
Hypocalcemia
|
8 participants
|
—
|
—
|
—
|
—
|
|
Toxicity as Assessed by NCI CTCAE Version 4.00 When AUG922 Administered at Its MTD (Phase I and II)
Anemia
|
4 participants
|
—
|
—
|
—
|
—
|
|
Toxicity as Assessed by NCI CTCAE Version 4.00 When AUG922 Administered at Its MTD (Phase I and II)
Mucositis
|
6 participants
|
—
|
—
|
—
|
—
|
|
Toxicity as Assessed by NCI CTCAE Version 4.00 When AUG922 Administered at Its MTD (Phase I and II)
Decreased lymphocytes
|
6 participants
|
—
|
—
|
—
|
—
|
|
Toxicity as Assessed by NCI CTCAE Version 4.00 When AUG922 Administered at Its MTD (Phase I and II)
Decreased platelets
|
6 participants
|
—
|
—
|
—
|
—
|
|
Toxicity as Assessed by NCI CTCAE Version 4.00 When AUG922 Administered at Its MTD (Phase I and II)
Hypomagnesemia
|
6 participants
|
—
|
—
|
—
|
—
|
|
Toxicity as Assessed by NCI CTCAE Version 4.00 When AUG922 Administered at Its MTD (Phase I and II)
Decreased neutrophils
|
5 participants
|
—
|
—
|
—
|
—
|
|
Toxicity as Assessed by NCI CTCAE Version 4.00 When AUG922 Administered at Its MTD (Phase I and II)
Elevated bilirubin
|
16 participants
|
—
|
—
|
—
|
—
|
|
Toxicity as Assessed by NCI CTCAE Version 4.00 When AUG922 Administered at Its MTD (Phase I and II)
Myalgias/arthralgias
|
9 participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At weeks 1 through 4 and then every 2 weeks during treatment and 30 days post last treatment, for up to 2 years and half yearsPopulation: Most frequent adverse events for patients treated with 25 to 55mg/m2 dose of AUY9222.
Adverse events will be collected weekly for the first 28 day cycle and then every two weeks during treatment and up to 28 days after the last treatment. Adverse events will be graded according to the National Cancer Institute's Common Toxicity Criteria for adverse events version 4.0 (CTCAE v4.0). In general adverse events (AEs) will be graded according to the following: Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE
Outcome measures
| Measure |
Cohort 1 - 25 mg/m2 AUY922+75 mg Daily Erlotinib
n=12 Participants
Patients receive Hsp90 inhibitor AUY922 IV over 1 hour once weekly and oral erlotinib hydrochloride once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
erlotinib hydrochloride: Given orally
Hsp90 inhibitor AUY922: Given IV
laboratory biomarker analysis: Correlative studies
needle biopsy: Undergo image-guided needle biopsy (correlative studies)
mutation analysis: Correlative studies
pharmacological study: Correlative studies
|
Cohort 2 - 25 mg/m2AUY922+150 mg Daily Erlotinib
Patients receive Hsp90 inhibitor AUY922 IV over 1 hour once weekly and oral erlotinib hydrochloride once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
erlotinib hydrochloride: Given orally
Hsp90 inhibitor AUY922: Given IV
laboratory biomarker analysis: Correlative studies
needle biopsy: Undergo image-guided needle biopsy (correlative studies)
mutation analysis: Correlative studies
pharmacological study: Correlative studies
|
Cohort 3 - 37.5 mg/m2 AUY922+150 mg Daily Erlotinib
Patients receive Hsp90 inhibitor AUY922 IV over 1 hour once weekly and oral erlotinib hydrochloride once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
erlotinib hydrochloride: Given orally
Hsp90 inhibitor AUY922: Given IV
laboratory biomarker analysis: Correlative studies
needle biopsy: Undergo image-guided needle biopsy (correlative studies)
mutation analysis: Correlative studies
pharmacological study: Correlative studies
|
Cohort 4 - 55 mg/m2 AUY922+150 mg Daily Erlotinib
Patients receive Hsp90 inhibitor AUY922 IV over 1 hour once weekly and oral erlotinib hydrochloride once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
erlotinib hydrochloride: Given orally
Hsp90 inhibitor AUY922: Given IV
laboratory biomarker analysis: Correlative studies
needle biopsy: Undergo image-guided needle biopsy (correlative studies)
mutation analysis: Correlative studies
pharmacological study: Correlative studies
|
Cohort 5 - 70 mg/m2 AUY922+150 mg Daily Erlotinib
Patients receive Hsp90 inhibitor AUY922 IV over 1 hour once weekly and oral erlotinib hydrochloride once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
erlotinib hydrochloride: Given orally
Hsp90 inhibitor AUY922: Given IV
laboratory biomarker analysis: Correlative studies
needle biopsy: Undergo image-guided needle biopsy (correlative studies)
mutation analysis: Correlative studies
pharmacological study: Correlative studies
|
|---|---|---|---|---|---|
|
Incidence of Reported Adverse Events in Phase I
Diarrhea
|
11 participants
|
—
|
—
|
—
|
—
|
|
Incidence of Reported Adverse Events in Phase I
Skin rash
|
9 participants
|
—
|
—
|
—
|
—
|
|
Incidence of Reported Adverse Events in Phase I
Hyperglycemia
|
0 participants
|
—
|
—
|
—
|
—
|
|
Incidence of Reported Adverse Events in Phase I
Night blindness
|
3 participants
|
—
|
—
|
—
|
—
|
|
Incidence of Reported Adverse Events in Phase I
Hypoalbuminemia
|
0 participants
|
—
|
—
|
—
|
—
|
|
Incidence of Reported Adverse Events in Phase I
Fatigue
|
8 participants
|
—
|
—
|
—
|
—
|
|
Incidence of Reported Adverse Events in Phase I
Elevated AST
|
1 participants
|
—
|
—
|
—
|
—
|
|
Incidence of Reported Adverse Events in Phase I
Hyponatremia
|
0 participants
|
—
|
—
|
—
|
—
|
|
Incidence of Reported Adverse Events in Phase I
Elevated bilirubin
|
0 participants
|
—
|
—
|
—
|
—
|
|
Incidence of Reported Adverse Events in Phase I
Elevated ALT
|
0 participants
|
—
|
—
|
—
|
—
|
|
Incidence of Reported Adverse Events in Phase I
Myalgias/arthralgias
|
5 participants
|
—
|
—
|
—
|
—
|
|
Incidence of Reported Adverse Events in Phase I
Visual complaints
|
4 participants
|
—
|
—
|
—
|
—
|
|
Incidence of Reported Adverse Events in Phase I
Vomiting
|
4 participants
|
—
|
—
|
—
|
—
|
|
Incidence of Reported Adverse Events in Phase I
Elevated ALP
|
0 participants
|
—
|
—
|
—
|
—
|
|
Incidence of Reported Adverse Events in Phase I
Decreased leukocytes
|
0 participants
|
—
|
—
|
—
|
—
|
|
Incidence of Reported Adverse Events in Phase I
hypokalemia
|
0 participants
|
—
|
—
|
—
|
—
|
|
Incidence of Reported Adverse Events in Phase I
Pruritis/dry skin
|
4 participants
|
—
|
—
|
—
|
—
|
|
Incidence of Reported Adverse Events in Phase I
Hypocalcemia
|
0 participants
|
—
|
—
|
—
|
—
|
|
Incidence of Reported Adverse Events in Phase I
anemia
|
2 participants
|
—
|
—
|
—
|
—
|
|
Incidence of Reported Adverse Events in Phase I
Mucositis
|
0 participants
|
—
|
—
|
—
|
—
|
|
Incidence of Reported Adverse Events in Phase I
Decreased lymphocytes
|
0 participants
|
—
|
—
|
—
|
—
|
|
Incidence of Reported Adverse Events in Phase I
Decreased platelets
|
0 participants
|
—
|
—
|
—
|
—
|
|
Incidence of Reported Adverse Events in Phase I
Nausea
|
8 participants
|
—
|
—
|
—
|
—
|
|
Incidence of Reported Adverse Events in Phase I
Hypomagnesemia
|
0 participants
|
—
|
—
|
—
|
—
|
|
Incidence of Reported Adverse Events in Phase I
Decreased neutrophils
|
0 participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From the time of first treatment with AUY922 to disease progression for up to 2 years post treatmentPopulation: 25 of the patients were treated at the MTD and were evaluable for progression free survival. Data was collected up until September 30 2014 when study was closed permanently and no further data was collected for patients survival due to IND withdrawal.
Median Progression Free Survival (PFS) will be calculated from time of treatment initiation until the first documentation of progressive disease. Patients will be considered to have progressive disease when CT scan or MRI show at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Outcome measures
| Measure |
Cohort 1 - 25 mg/m2 AUY922+75 mg Daily Erlotinib
n=25 Participants
Patients receive Hsp90 inhibitor AUY922 IV over 1 hour once weekly and oral erlotinib hydrochloride once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
erlotinib hydrochloride: Given orally
Hsp90 inhibitor AUY922: Given IV
laboratory biomarker analysis: Correlative studies
needle biopsy: Undergo image-guided needle biopsy (correlative studies)
mutation analysis: Correlative studies
pharmacological study: Correlative studies
|
Cohort 2 - 25 mg/m2AUY922+150 mg Daily Erlotinib
Patients receive Hsp90 inhibitor AUY922 IV over 1 hour once weekly and oral erlotinib hydrochloride once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
erlotinib hydrochloride: Given orally
Hsp90 inhibitor AUY922: Given IV
laboratory biomarker analysis: Correlative studies
needle biopsy: Undergo image-guided needle biopsy (correlative studies)
mutation analysis: Correlative studies
pharmacological study: Correlative studies
|
Cohort 3 - 37.5 mg/m2 AUY922+150 mg Daily Erlotinib
Patients receive Hsp90 inhibitor AUY922 IV over 1 hour once weekly and oral erlotinib hydrochloride once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
erlotinib hydrochloride: Given orally
Hsp90 inhibitor AUY922: Given IV
laboratory biomarker analysis: Correlative studies
needle biopsy: Undergo image-guided needle biopsy (correlative studies)
mutation analysis: Correlative studies
pharmacological study: Correlative studies
|
Cohort 4 - 55 mg/m2 AUY922+150 mg Daily Erlotinib
Patients receive Hsp90 inhibitor AUY922 IV over 1 hour once weekly and oral erlotinib hydrochloride once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
erlotinib hydrochloride: Given orally
Hsp90 inhibitor AUY922: Given IV
laboratory biomarker analysis: Correlative studies
needle biopsy: Undergo image-guided needle biopsy (correlative studies)
mutation analysis: Correlative studies
pharmacological study: Correlative studies
|
Cohort 5 - 70 mg/m2 AUY922+150 mg Daily Erlotinib
Patients receive Hsp90 inhibitor AUY922 IV over 1 hour once weekly and oral erlotinib hydrochloride once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
erlotinib hydrochloride: Given orally
Hsp90 inhibitor AUY922: Given IV
laboratory biomarker analysis: Correlative studies
needle biopsy: Undergo image-guided needle biopsy (correlative studies)
mutation analysis: Correlative studies
pharmacological study: Correlative studies
|
|---|---|---|---|---|---|
|
Progression-free Survival (Phase II)
|
1.7 Months
Interval 1.1 to 4.9
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From the time of first treatment with AUY922 to death, followed up to 2 years post treatmentPopulation: 25 of the patients were treated at the MTD and were evaluable for progression free survival. Data was collected up until September 30 2014 when study was closed permanently and no further data was collected for patients survival due to IND withdrawal.
Overall survival (OS) is defined as the time from treatment initiation until death due to any cause.
Outcome measures
| Measure |
Cohort 1 - 25 mg/m2 AUY922+75 mg Daily Erlotinib
n=25 Participants
Patients receive Hsp90 inhibitor AUY922 IV over 1 hour once weekly and oral erlotinib hydrochloride once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
erlotinib hydrochloride: Given orally
Hsp90 inhibitor AUY922: Given IV
laboratory biomarker analysis: Correlative studies
needle biopsy: Undergo image-guided needle biopsy (correlative studies)
mutation analysis: Correlative studies
pharmacological study: Correlative studies
|
Cohort 2 - 25 mg/m2AUY922+150 mg Daily Erlotinib
Patients receive Hsp90 inhibitor AUY922 IV over 1 hour once weekly and oral erlotinib hydrochloride once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
erlotinib hydrochloride: Given orally
Hsp90 inhibitor AUY922: Given IV
laboratory biomarker analysis: Correlative studies
needle biopsy: Undergo image-guided needle biopsy (correlative studies)
mutation analysis: Correlative studies
pharmacological study: Correlative studies
|
Cohort 3 - 37.5 mg/m2 AUY922+150 mg Daily Erlotinib
Patients receive Hsp90 inhibitor AUY922 IV over 1 hour once weekly and oral erlotinib hydrochloride once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
erlotinib hydrochloride: Given orally
Hsp90 inhibitor AUY922: Given IV
laboratory biomarker analysis: Correlative studies
needle biopsy: Undergo image-guided needle biopsy (correlative studies)
mutation analysis: Correlative studies
pharmacological study: Correlative studies
|
Cohort 4 - 55 mg/m2 AUY922+150 mg Daily Erlotinib
Patients receive Hsp90 inhibitor AUY922 IV over 1 hour once weekly and oral erlotinib hydrochloride once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
erlotinib hydrochloride: Given orally
Hsp90 inhibitor AUY922: Given IV
laboratory biomarker analysis: Correlative studies
needle biopsy: Undergo image-guided needle biopsy (correlative studies)
mutation analysis: Correlative studies
pharmacological study: Correlative studies
|
Cohort 5 - 70 mg/m2 AUY922+150 mg Daily Erlotinib
Patients receive Hsp90 inhibitor AUY922 IV over 1 hour once weekly and oral erlotinib hydrochloride once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
erlotinib hydrochloride: Given orally
Hsp90 inhibitor AUY922: Given IV
laboratory biomarker analysis: Correlative studies
needle biopsy: Undergo image-guided needle biopsy (correlative studies)
mutation analysis: Correlative studies
pharmacological study: Correlative studies
|
|---|---|---|---|---|---|
|
Overall Survival (Phase II)
|
7.4 Months
Interval 4.0 to 17.9
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From the time of first treatment with AUY922 to death, followed for up to 2 yearsPopulation: No data was collected or analyzed for this outcome measure. There is no data to report. IND was withdrawn before the studies anticipated termination date.
Overall Survival (OS) will be measured from treatment initiation until death due to any cause for patients with acquired resistance with T790M mutations in the phase II portion of the study.
Outcome measures
Outcome data not reported
Adverse Events
Cohort 1 - 25 mg/m2 AUY922+75 mg Daily Erlotinib
Serious events: 1 serious events
Other events: 3 other events
Deaths: 3 deaths
Cohort 2 - 25 mg/m2AUY922+150 mg Daily Erlotinib
Serious events: 1 serious events
Other events: 3 other events
Deaths: 3 deaths
Cohort 3 - 37.5 mg/m2 AUY922+150 mg Daily Erlotinib
Serious events: 1 serious events
Other events: 3 other events
Deaths: 3 deaths
Cohort 4 - 55 mg/m2 AUY922+150 mg Daily Erlotinib
Serious events: 1 serious events
Other events: 3 other events
Deaths: 3 deaths
Cohort 5 - 70 mg/m2 AUY922+150 mg Daily Erlotinib
Serious events: 2 serious events
Other events: 6 other events
Deaths: 6 deaths
Phase II- 70 mg/m2 AUY922+150 mg Daily Erlotinib
Serious events: 1 serious events
Other events: 19 other events
Deaths: 13 deaths
Serious adverse events
| Measure |
Cohort 1 - 25 mg/m2 AUY922+75 mg Daily Erlotinib
n=3 participants at risk
Patients receive Hsp90 inhibitor AUY922 IV over 1 hour once weekly and 75mg oral erlotinib hydrochloride once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
erlotinib hydrochloride: Given orally
Hsp90 inhibitor AUY922: Given IV
laboratory biomarker analysis: Correlative studies
needle biopsy: Undergo image-guided needle biopsy (correlative studies)
mutation analysis: Correlative studies
pharmacological study: Correlative studies
|
Cohort 2 - 25 mg/m2AUY922+150 mg Daily Erlotinib
n=3 participants at risk
Patients receive Hsp90 inhibitor AUY922 IV over 1 hour once weekly and oral erlotinib hydrochloride once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
erlotinib hydrochloride: Given orally
Hsp90 inhibitor AUY922: Given IV
laboratory biomarker analysis: Correlative studies
needle biopsy: Undergo image-guided needle biopsy (correlative studies)
mutation analysis: Correlative studies
pharmacological study: Correlative studies
|
Cohort 3 - 37.5 mg/m2 AUY922+150 mg Daily Erlotinib
n=3 participants at risk
Patients receive Hsp90 inhibitor AUY922 IV over 1 hour once weekly and 75mg oral erlotinib hydrochloride once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
erlotinib hydrochloride: Given orally
Hsp90 inhibitor AUY922: Given IV
laboratory biomarker analysis: Correlative studies
needle biopsy: Undergo image-guided needle biopsy (correlative studies)
mutation analysis: Correlative studies
pharmacological study: Correlative studies
|
Cohort 4 - 55 mg/m2 AUY922+150 mg Daily Erlotinib
n=3 participants at risk
Patients receive Hsp90 inhibitor AUY922 IV over 1 hour once weekly and 75mg oral erlotinib hydrochloride once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
erlotinib hydrochloride: Given orally
Hsp90 inhibitor AUY922: Given IV
laboratory biomarker analysis: Correlative studies
needle biopsy: Undergo image-guided needle biopsy (correlative studies)
mutation analysis: Correlative studies
pharmacological study: Correlative studies
|
Cohort 5 - 70 mg/m2 AUY922+150 mg Daily Erlotinib
n=6 participants at risk
Patients receive Hsp90 inhibitor AUY922 IV over 1 hour once weekly and 75mg oral erlotinib hydrochloride once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
erlotinib hydrochloride: Given orally
Hsp90 inhibitor AUY922: Given IV
laboratory biomarker analysis: Correlative studies
needle biopsy: Undergo image-guided needle biopsy (correlative studies)
mutation analysis: Correlative studies
pharmacological study: Correlative studies
|
Phase II- 70 mg/m2 AUY922+150 mg Daily Erlotinib
n=19 participants at risk
Patients receive Hsp90 inhibitor AUY922 IV over 1 hour once weekly and 75mg oral erlotinib hydrochloride once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
erlotinib hydrochloride: Given orally
Hsp90 inhibitor AUY922: Given IV
laboratory biomarker analysis: Correlative studies
needle biopsy: Undergo image-guided needle biopsy (correlative studies)
mutation analysis: Correlative studies
pharmacological study: Correlative studies
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
Gastrointestinal disorders
Ileal obstruction
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
Musculoskeletal and connective tissue disorders
Tumor pain
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
Nervous system disorders
Memory impairment
|
33.3%
1/3 • Number of events 1 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
Nervous system disorders
Cognitive disturbance
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
5.3%
1/19 • Number of events 2 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
Cardiac disorders
Conduction disorder
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Progressive disease
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
Gastrointestinal disorders
Diarrhea with blood
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pain
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
Other adverse events
| Measure |
Cohort 1 - 25 mg/m2 AUY922+75 mg Daily Erlotinib
n=3 participants at risk
Patients receive Hsp90 inhibitor AUY922 IV over 1 hour once weekly and 75mg oral erlotinib hydrochloride once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
erlotinib hydrochloride: Given orally
Hsp90 inhibitor AUY922: Given IV
laboratory biomarker analysis: Correlative studies
needle biopsy: Undergo image-guided needle biopsy (correlative studies)
mutation analysis: Correlative studies
pharmacological study: Correlative studies
|
Cohort 2 - 25 mg/m2AUY922+150 mg Daily Erlotinib
n=3 participants at risk
Patients receive Hsp90 inhibitor AUY922 IV over 1 hour once weekly and oral erlotinib hydrochloride once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
erlotinib hydrochloride: Given orally
Hsp90 inhibitor AUY922: Given IV
laboratory biomarker analysis: Correlative studies
needle biopsy: Undergo image-guided needle biopsy (correlative studies)
mutation analysis: Correlative studies
pharmacological study: Correlative studies
|
Cohort 3 - 37.5 mg/m2 AUY922+150 mg Daily Erlotinib
n=3 participants at risk
Patients receive Hsp90 inhibitor AUY922 IV over 1 hour once weekly and 75mg oral erlotinib hydrochloride once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
erlotinib hydrochloride: Given orally
Hsp90 inhibitor AUY922: Given IV
laboratory biomarker analysis: Correlative studies
needle biopsy: Undergo image-guided needle biopsy (correlative studies)
mutation analysis: Correlative studies
pharmacological study: Correlative studies
|
Cohort 4 - 55 mg/m2 AUY922+150 mg Daily Erlotinib
n=3 participants at risk
Patients receive Hsp90 inhibitor AUY922 IV over 1 hour once weekly and 75mg oral erlotinib hydrochloride once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
erlotinib hydrochloride: Given orally
Hsp90 inhibitor AUY922: Given IV
laboratory biomarker analysis: Correlative studies
needle biopsy: Undergo image-guided needle biopsy (correlative studies)
mutation analysis: Correlative studies
pharmacological study: Correlative studies
|
Cohort 5 - 70 mg/m2 AUY922+150 mg Daily Erlotinib
n=6 participants at risk
Patients receive Hsp90 inhibitor AUY922 IV over 1 hour once weekly and 75mg oral erlotinib hydrochloride once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
erlotinib hydrochloride: Given orally
Hsp90 inhibitor AUY922: Given IV
laboratory biomarker analysis: Correlative studies
needle biopsy: Undergo image-guided needle biopsy (correlative studies)
mutation analysis: Correlative studies
pharmacological study: Correlative studies
|
Phase II- 70 mg/m2 AUY922+150 mg Daily Erlotinib
n=19 participants at risk
Patients receive Hsp90 inhibitor AUY922 IV over 1 hour once weekly and 75mg oral erlotinib hydrochloride once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
erlotinib hydrochloride: Given orally
Hsp90 inhibitor AUY922: Given IV
laboratory biomarker analysis: Correlative studies
needle biopsy: Undergo image-guided needle biopsy (correlative studies)
mutation analysis: Correlative studies
pharmacological study: Correlative studies
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
33.3%
1/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
33.3%
1/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
16.7%
1/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
15.8%
3/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
Cardiac disorders
Atrioventricular block first degree
|
33.3%
1/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
Cardiac disorders
Chest pain
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
16.7%
1/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
Ear and labyrinth disorders
Titnnitus
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
5.3%
1/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
5.3%
1/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
Eye disorders
Blurred vision
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
33.3%
1/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
15.8%
3/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
Eye disorders
Cataract
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
33.3%
1/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
Eye disorders
Conjunctivitis
|
33.3%
1/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
Eye disorders
Corneal ulcer
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
33.3%
1/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
Eye disorders
Dry eye
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
16.7%
1/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
Metabolism and nutrition disorders
Anorexia
|
33.3%
1/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
33.3%
1/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
33.3%
1/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
16.7%
1/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
5.3%
1/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
Eye disorders
Flashing lights
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
33.3%
1/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
33.3%
1/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
16.7%
1/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
Eye disorders
Floaters
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
16.7%
1/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
5.3%
1/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
Eye disorders
Night blindness
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
33.3%
1/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
66.7%
2/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
66.7%
4/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
73.7%
14/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
33.3%
1/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
16.7%
1/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
33.3%
1/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
66.7%
2/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
50.0%
3/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
15.8%
3/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
Gastrointestinal disorders
Diarrhea
|
100.0%
3/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
100.0%
3/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
100.0%
3/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
66.7%
2/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
83.3%
5/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
100.0%
19/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
5.3%
1/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
33.3%
1/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
5.3%
1/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
16.7%
1/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
26.3%
5/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
Gastrointestinal disorders
Nausea
|
66.7%
2/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
66.7%
2/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
100.0%
3/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
33.3%
1/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
33.3%
2/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
36.8%
7/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
16.7%
1/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
33.3%
1/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
33.3%
1/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
33.3%
1/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
42.1%
8/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
General disorders
Chills
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
5.3%
1/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
General disorders
Fatigue
|
100.0%
3/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
100.0%
3/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
100.0%
3/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
100.0%
3/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
83.3%
5/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
94.7%
18/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
General disorders
Fever
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
33.3%
1/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
General disorders
Gait disturbance
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
16.7%
1/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
General disorders
Non-cardiac chest pain
|
33.3%
1/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
General disorders
Pain
|
66.7%
2/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
16.7%
1/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
5.3%
1/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
Infections and infestations
Eye Infection
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
33.3%
1/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
33.3%
1/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
Infections and infestations
Papulopustular rash
|
33.3%
1/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
5.3%
1/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
Infections and infestations
Paronychia
|
33.3%
1/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
33.3%
1/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
10.5%
2/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
Infections and infestations
Upper Respiratory Infection
|
66.7%
2/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
33.3%
1/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
16.7%
1/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
5.3%
1/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
66.7%
4/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
52.6%
10/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
16.7%
1/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
47.4%
9/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
33.3%
1/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
16.7%
1/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
84.2%
16/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
Investigations
Cholesterol high
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
33.3%
1/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
Investigations
Creatinine increased
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
15.8%
3/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
33.3%
2/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
21.1%
4/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
Investigations
Weight loss
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
16.7%
1/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
5.3%
1/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
Investigations
White blood cell decreased
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
33.3%
2/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
42.1%
8/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
Investigations
Blood Bilirubin Increased
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
50.0%
3/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
68.4%
13/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
Investigations
Activated Partial Thromboplastin time Prolonged
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
16.7%
1/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
15.8%
3/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
Investigations
INR Increased
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
33.3%
2/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
5.3%
1/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
Investigations
Platelet Count Decreased
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
33.3%
2/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
21.1%
4/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
Investigations
Neutrophil Count Decreased
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
33.3%
2/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
15.8%
3/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
Investigations
Serum Amylase Increased
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
50.0%
3/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
16.7%
1/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
66.7%
4/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
94.7%
18/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
5.3%
1/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
83.3%
5/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
84.2%
16/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
33.3%
2/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
31.6%
6/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
33.3%
2/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
42.1%
8/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
16.7%
1/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
26.3%
5/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
50.0%
3/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
73.7%
14/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
16.7%
1/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
15.8%
3/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
16.7%
1/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
5.3%
1/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
33.3%
1/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
50.0%
3/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
66.7%
2/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
5.3%
1/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
33.3%
1/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
Musculoskeletal and connective tissue disorders
Generalized Muscle Weakness
|
33.3%
1/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
Musculoskeletal and connective tissue disorders
Joint Range of Motion Decreased
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
5.3%
1/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness, Left-sided
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
5.3%
1/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness Lower Limb
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
5.3%
1/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
33.3%
1/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
33.3%
1/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
5.3%
1/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
33.3%
1/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
33.3%
1/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
5.3%
1/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
33.3%
1/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
5.3%
1/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
5.3%
1/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
33.3%
1/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
5.3%
1/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
5.3%
1/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
33.3%
1/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
33.3%
1/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
33.3%
1/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
50.0%
3/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
47.4%
9/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
Nervous system disorders
Seizure
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
33.3%
1/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
16.7%
1/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
Psychiatric disorders
Depression
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
5.3%
1/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
66.7%
2/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
100.0%
3/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
66.7%
2/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
100.0%
3/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
100.0%
6/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
84.2%
16/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
66.7%
2/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
33.3%
1/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
33.3%
1/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
100.0%
3/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
83.3%
5/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
63.2%
12/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
33.3%
1/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
16.7%
1/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
5.3%
1/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
5.3%
1/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
33.3%
1/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
5.3%
1/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
16.7%
1/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
33.3%
1/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
33.3%
1/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
33.3%
1/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
33.3%
1/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
33.3%
2/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
5.3%
1/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
Respiratory, thoracic and mediastinal disorders
Erythema Multiforme
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
5.3%
1/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
Skin and subcutaneous tissue disorders
Hirsutism
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
5.3%
1/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
33.3%
1/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
33.3%
1/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
33.3%
2/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
15.8%
3/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
Skin and subcutaneous tissue disorders
Rash Acneiform
|
33.3%
1/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
33.3%
1/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
50.0%
3/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
21.1%
4/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-papular
|
33.3%
1/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
33.3%
1/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
33.3%
1/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
33.3%
1/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
16.7%
1/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
21.1%
4/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
Social circumstances
Menopause
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
33.3%
1/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
21.1%
4/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
33.3%
1/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
Blood and lymphatic system disorders
Bleeding
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
33.3%
1/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
5.3%
1/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
Blood and lymphatic system disorders
Bleeding gums
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
5.3%
1/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
Blood and lymphatic system disorders
Blood in sputum
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
16.7%
1/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
5.3%
1/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
Eye disorders
Visual Disturbances
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
33.3%
2/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
15.8%
3/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
Eye disorders
Trichiasis of the eyelid
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
33.3%
1/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
General disorders
Fissures
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
33.3%
1/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
10.5%
2/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
Gastrointestinal disorders
Clostridium Difficile (C Diff)
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
33.3%
1/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
General disorders
Decreased Appetite
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
33.3%
1/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
Gastrointestinal disorders
Cold intolerance
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
33.3%
1/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
General disorders
Taste changes
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
33.3%
1/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
General disorders
Bruise at port site
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
16.7%
1/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
General disorders
Night Sweats
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
5.3%
1/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
Infections and infestations
Reaction at port site
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
33.3%
1/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
33.3%
1/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
Musculoskeletal and connective tissue disorders
Muscle cramps
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
33.3%
2/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
21.1%
4/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
Musculoskeletal and connective tissue disorders
Tremors
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
5.3%
1/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
Musculoskeletal and connective tissue disorders
Leg and hip pain/weakness
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
5.3%
1/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
33.3%
1/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
33.3%
1/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
33.3%
1/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
Skin and subcutaneous tissue disorders
Rash from cut
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
33.3%
1/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
Skin and subcutaneous tissue disorders
Sores in mouth
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
33.3%
1/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
Skin and subcutaneous tissue disorders
Redness on bottom lip
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
16.7%
1/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
|
Nervous system disorders
New progressive leptomeningeal disease
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/3 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
16.7%
1/6 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
0.00%
0/19 • Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
|
Additional Information
Clinical Trials Office
Northwestern University
Phone: 312-695-1301
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place