Trial Outcomes & Findings for Bortezomib With or Without Irinotecan in Treating Patients With Locally Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (NCT NCT00103259)
NCT ID: NCT00103259
Last Updated: 2014-05-23
Results Overview
Tumor response was evaluated via Response Evaluation Criteria In Solid Tumors (RECIST) v1.0, and response rate was defined as the proportion of patients with a complete response or partial response among all eligible and treated patients. Complete response was defined as disappearance of all tumor lesions. Partial response was defined as at least a 30% decrease in the sum of the longest diameters of target lesions.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
71 participants
Primary outcome timeframe
Tumor response was assessed every 2 cycles until progression or intolerable toxicity with maximum of 3 years
Results posted on
2014-05-23
Participant Flow
E1304 was open to accrual on July 20, 2005 and was suspended on September 29, 2006. The trial was reactivated on October 18, 2006 with dose reduction for irinotecan. Arm I was closed with 27 patients after stage I. Arm B proceeded to the second stage of accrual without suspension and closed on September 24, 2008 after enrolling 44 patients.
Participant milestones
| Measure |
Arm I (Bortezomib+Irinotecan)
Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11 and irinotecan hydrochloride IV over 90 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Arm II (Bortezomib)
Patients receive bortezomib (PS-341) 1.3 mg/m2 IV over 3-5 seconds twice weekly on days 1, 4, 8 and 11 followed by one week of rest. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Upon disease progression, patients may cross over to arm I (bortezomib + irinotecan).
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
44
|
|
Overall Study
Eligible
|
27
|
41
|
|
Overall Study
Treated
|
23
|
41
|
|
Overall Study
Eligible and Treated
|
23
|
38
|
|
Overall Study
Cross Over to the Other Arm
|
0
|
11
|
|
Overall Study
Eligible Patients Who Cross Over
|
0
|
10
|
|
Overall Study
COMPLETED
|
15
|
32
|
|
Overall Study
NOT COMPLETED
|
12
|
12
|
Reasons for withdrawal
| Measure |
Arm I (Bortezomib+Irinotecan)
Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11 and irinotecan hydrochloride IV over 90 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Arm II (Bortezomib)
Patients receive bortezomib (PS-341) 1.3 mg/m2 IV over 3-5 seconds twice weekly on days 1, 4, 8 and 11 followed by one week of rest. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Upon disease progression, patients may cross over to arm I (bortezomib + irinotecan).
|
|---|---|---|
|
Overall Study
Death
|
3
|
2
|
|
Overall Study
Withdrawal by Subject
|
2
|
3
|
|
Overall Study
alternative therapy
|
1
|
0
|
|
Overall Study
other (reasons were not specified)
|
2
|
1
|
|
Overall Study
ineligible/no protocol therapy
|
4
|
6
|
Baseline Characteristics
Bortezomib With or Without Irinotecan in Treating Patients With Locally Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
Baseline characteristics by cohort
| Measure |
Arm I (Bortezomib+Irinotecan)
n=23 Participants
Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11 and irinotecan hydrochloride IV over 90 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Arm II (Bortezomib)
n=38 Participants
Patients receive bortezomib (PS-341) 1.3 mg/m2 IV over 3-5 seconds twice weekly on days 1, 4, 8 and 11 followed by one week of rest. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Upon disease progression, patients may cross over to arm I (bortezomib + irinotecan).
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61 years
n=5 Participants
|
61 years
n=7 Participants
|
61 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
23 participants
n=5 Participants
|
38 participants
n=7 Participants
|
61 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Tumor response was assessed every 2 cycles until progression or intolerable toxicity with maximum of 3 yearsPopulation: 61 eligible and treated patients were included in the analysis
Tumor response was evaluated via Response Evaluation Criteria In Solid Tumors (RECIST) v1.0, and response rate was defined as the proportion of patients with a complete response or partial response among all eligible and treated patients. Complete response was defined as disappearance of all tumor lesions. Partial response was defined as at least a 30% decrease in the sum of the longest diameters of target lesions.
Outcome measures
| Measure |
Arm I (Bortezomib+Irinotecan)
n=23 Participants
Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11 and irinotecan hydrochloride IV over 90 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Arm II (Bortezomib)
n=38 Participants
Patients receive bortezomib (PS-341) 1.3 mg/m2 IV over 3-5 seconds twice weekly on days 1, 4, 8 and 11 followed by one week of rest. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Upon disease progression, patients may cross over to arm I (bortezomib + irinotecan).
|
|---|---|---|
|
Response Rate on Step 1
|
13.1 percentage of participants
Interval 3.6 to 30.3
|
2.6 percentage of participants
Interval 0.4 to 22.1
|
SECONDARY outcome
Timeframe: Tumor response was assessed after every 2 cycles until progression or intolerable toxicity with maximum of 3 yearsPopulation: 10 eligible and treated patients who progressed on bortezomib and crossed over to bortezomib and irinotecan arm were included in the analysis
Tumor response was evaluated via Response Evaluation Criteria In Solid Tumors (RECIST) v1.0, and response rate was defined as the proportion of patients with a complete response or partial response among all eligible and treated patients. Complete response was defined as disappearance of all tumor lesions. Partial response was defined as at least a 30% decrease in the sum of the longest diameters of target lesions.
Outcome measures
| Measure |
Arm I (Bortezomib+Irinotecan)
n=10 Participants
Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11 and irinotecan hydrochloride IV over 90 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Arm II (Bortezomib)
Patients receive bortezomib (PS-341) 1.3 mg/m2 IV over 3-5 seconds twice weekly on days 1, 4, 8 and 11 followed by one week of rest. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Upon disease progression, patients may cross over to arm I (bortezomib + irinotecan).
|
|---|---|---|
|
Response Rate on Step 2
|
0 percentage of participants
Interval 0.0 to 25.9
|
—
|
SECONDARY outcome
Timeframe: Every 3 months for first 2 years from protocol entry, then every 6 months until 3 years from study entryPopulation: 61 eligible and treated patients were included in the analysis
Progression-free survival was defined as time from registration to step 1 to disease recurrence or death from any cause, whichever occurred first. Disease progression was measured by Response Evaluation Criteria In Solid Tumors (RECIST) v1.0, and defined as at least a 20% increase in the sum of the longest diameters of target lesions.
Outcome measures
| Measure |
Arm I (Bortezomib+Irinotecan)
n=23 Participants
Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11 and irinotecan hydrochloride IV over 90 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Arm II (Bortezomib)
n=38 Participants
Patients receive bortezomib (PS-341) 1.3 mg/m2 IV over 3-5 seconds twice weekly on days 1, 4, 8 and 11 followed by one week of rest. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Upon disease progression, patients may cross over to arm I (bortezomib + irinotecan).
|
|---|---|---|
|
Progression-free Survival on Step 1
|
1.6 months
Interval 1.2 to 7.3
|
1.5 months
Interval 1.4 to 2.7
|
SECONDARY outcome
Timeframe: Survival was assessed every 3 month within 2 years and every 6 months betwen 2 and 3 yearsPopulation: 61 eligible and treated patients were included in the analysis
Overall survival was defined as time from registration on step 1 to death from any cause. It was evaluated in all 61 eligible and treated patients.
Outcome measures
| Measure |
Arm I (Bortezomib+Irinotecan)
n=23 Participants
Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11 and irinotecan hydrochloride IV over 90 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Arm II (Bortezomib)
n=38 Participants
Patients receive bortezomib (PS-341) 1.3 mg/m2 IV over 3-5 seconds twice weekly on days 1, 4, 8 and 11 followed by one week of rest. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Upon disease progression, patients may cross over to arm I (bortezomib + irinotecan).
|
|---|---|---|
|
Overall Survival on Step 1
|
9.1 months
Interval 2.3 to 12.5
|
7.3 months
Interval 5.1 to 9.4
|
Adverse Events
Arm I (Bortezomib+Irinotecan)
Serious events: 17 serious events
Other events: 23 other events
Deaths: 0 deaths
Arm II (Bortezomib)
Serious events: 21 serious events
Other events: 40 other events
Deaths: 0 deaths
Cross-over Patients
Serious events: 6 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm I (Bortezomib+Irinotecan)
n=23 participants at risk
Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11 and irinotecan hydrochloride IV over 90 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Arm II (Bortezomib)
n=41 participants at risk
Patients receive bortezomib (PS-341) 1.3 mg/m2 IV over 3-5 seconds twice weekly on days 1, 4, 8 and 11 followed by one week of rest. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Upon disease progression, patients may cross over to arm I (bortezomib + irinotecan).
|
Cross-over Patients
n=11 participants at risk
11 patients crossed over to bortezomib + irinotecan after progressed on bortezomib single agent. Adverse events were reported for the 11 patients while receiving the combination therapy.
|
|---|---|---|---|
|
Infections and infestations
Infection w/ gr0-2 neut, blood
|
4.3%
1/23 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
0.00%
0/41 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
0.00%
0/11 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
4.3%
1/23 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
0.00%
0/41 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
9.1%
1/11 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
|
Blood and lymphatic system disorders
Anemia
|
17.4%
4/23 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
4.9%
2/41 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
0.00%
0/11 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
|
Investigations
Leukopenia (Leukocytes decreased)
|
21.7%
5/23 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
2.4%
1/41 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
18.2%
2/11 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
|
Investigations
Lymphopenia
|
4.3%
1/23 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
9.8%
4/41 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
9.1%
1/11 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
|
Investigations
Neutropenia (Neutrophils decreased)
|
17.4%
4/23 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
2.4%
1/41 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
9.1%
1/11 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
|
Investigations
Thrombocytopenia (Platelets decreased)
|
17.4%
4/23 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
2.4%
1/41 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
9.1%
1/11 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
|
Vascular disorders
Hypotension
|
8.7%
2/23 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
4.9%
2/41 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
0.00%
0/11 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
|
General disorders
Fatigue
|
0.00%
0/23 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
17.1%
7/41 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
9.1%
1/11 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
|
General disorders
Fever w/o neutropenia
|
4.3%
1/23 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
0.00%
0/41 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
0.00%
0/11 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
|
Psychiatric disorders
Insomnia
|
4.3%
1/23 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
0.00%
0/41 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
0.00%
0/11 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
|
General disorders
Constitutional, other
|
4.3%
1/23 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
0.00%
0/41 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
0.00%
0/11 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
|
Metabolism and nutrition disorders
Anorexia
|
13.0%
3/23 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
0.00%
0/41 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
18.2%
2/11 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/23 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
2.4%
1/41 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
0.00%
0/11 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
|
Metabolism and nutrition disorders
Dehydration
|
17.4%
4/23 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
0.00%
0/41 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
27.3%
3/11 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
|
Gastrointestinal disorders
Diarrhea w/o prior colostomy
|
21.7%
5/23 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
2.4%
1/41 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
9.1%
1/11 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
|
Gastrointestinal disorders
Nausea
|
13.0%
3/23 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
0.00%
0/41 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
0.00%
0/11 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
|
Gastrointestinal disorders
Vomiting
|
17.4%
4/23 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
0.00%
0/41 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
0.00%
0/11 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
|
Gastrointestinal disorders
Stomach, hemorrhage
|
4.3%
1/23 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
0.00%
0/41 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
0.00%
0/11 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
|
Infections and infestations
Infection w/ gr3-4 neut, lung
|
4.3%
1/23 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
0.00%
0/41 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
9.1%
1/11 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
|
Infections and infestations
Infection w/ gr0-2 neut, lung
|
4.3%
1/23 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
0.00%
0/41 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
0.00%
0/11 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
|
Infections and infestations
Infection w/ gr0-2 neut, trachea
|
0.00%
0/23 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
2.4%
1/41 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
0.00%
0/11 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
|
Infections and infestations
Infection w/ unknown ANC foreign body
|
4.3%
1/23 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
0.00%
0/41 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
0.00%
0/11 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
|
Renal and urinary disorders
Glomerular filtration rate decreased
|
4.3%
1/23 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
0.00%
0/41 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
0.00%
0/11 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/23 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
2.4%
1/41 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
0.00%
0/11 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
|
Metabolism and nutrition disorders
Hypokalemia
|
13.0%
3/23 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
4.9%
2/41 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
9.1%
1/11 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
|
Metabolism and nutrition disorders
Hyponatremia
|
17.4%
4/23 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
2.4%
1/41 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
0.00%
0/11 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
|
Musculoskeletal and connective tissue disorders
Non-neuropathic generalized weekness
|
0.00%
0/23 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
2.4%
1/41 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
0.00%
0/11 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
|
Nervous system disorders
Dizziness
|
0.00%
0/23 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
9.8%
4/41 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
0.00%
0/11 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
|
Nervous system disorders
Neuropathy-sensory
|
0.00%
0/23 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
7.3%
3/41 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
0.00%
0/11 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
|
Nervous system disorders
Syncope
|
0.00%
0/23 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
2.4%
1/41 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
0.00%
0/11 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
|
Gastrointestinal disorders
Abdomen, pain
|
0.00%
0/23 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
2.4%
1/41 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
0.00%
0/11 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
4.3%
1/23 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
0.00%
0/41 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
0.00%
0/11 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
4.3%
1/23 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
0.00%
0/41 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
0.00%
0/11 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
4.3%
1/23 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
0.00%
0/41 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
9.1%
1/11 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
4.3%
1/23 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
0.00%
0/41 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
0.00%
0/11 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
|
Injury, poisoning and procedural complications
Vessel injury carotid
|
4.3%
1/23 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
0.00%
0/41 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
0.00%
0/11 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
|
General disorders
Death, NOS
|
4.3%
1/23 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
0.00%
0/41 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
0.00%
0/11 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
|
Gastrointestinal disorders
Obstruction, small bowel NOS
|
0.00%
0/23 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
0.00%
0/41 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
9.1%
1/11 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/23 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
0.00%
0/41 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
9.1%
1/11 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
Other adverse events
| Measure |
Arm I (Bortezomib+Irinotecan)
n=23 participants at risk
Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11 and irinotecan hydrochloride IV over 90 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Arm II (Bortezomib)
n=41 participants at risk
Patients receive bortezomib (PS-341) 1.3 mg/m2 IV over 3-5 seconds twice weekly on days 1, 4, 8 and 11 followed by one week of rest. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Upon disease progression, patients may cross over to arm I (bortezomib + irinotecan).
|
Cross-over Patients
n=11 participants at risk
11 patients crossed over to bortezomib + irinotecan after progressed on bortezomib single agent. Adverse events were reported for the 11 patients while receiving the combination therapy.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
91.3%
21/23 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
75.6%
31/41 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
90.9%
10/11 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
|
Investigations
Leukopenia (Leukocytes decreased)
|
52.2%
12/23 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
12.2%
5/41 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
45.5%
5/11 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
|
Investigations
Lymphopenia
|
8.7%
2/23 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
2.4%
1/41 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
0.00%
0/11 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
|
Investigations
Neutropenia (Neutrophils decreased)
|
26.1%
6/23 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
2.4%
1/41 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
27.3%
3/11 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
|
Investigations
Thrombocytopenia (Platelets decreased)
|
52.2%
12/23 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
34.1%
14/41 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
63.6%
7/11 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
|
Blood and lymphatic system disorders
Hematologic-other
|
8.7%
2/23 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
4.9%
2/41 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
0.00%
0/11 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
|
Vascular disorders
Hypotension
|
8.7%
2/23 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
9.8%
4/41 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
18.2%
2/11 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
|
General disorders
Fatigue
|
60.9%
14/23 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
41.5%
17/41 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
72.7%
8/11 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
|
General disorders
Fever w/o neutropenia
|
13.0%
3/23 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
4.9%
2/41 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
0.00%
0/11 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
|
Psychiatric disorders
Insomnia
|
8.7%
2/23 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
7.3%
3/41 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
18.2%
2/11 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
|
Investigations
Weight loss
|
21.7%
5/23 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
9.8%
4/41 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
27.3%
3/11 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
|
General disorders
Constitutional, other
|
17.4%
4/23 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
12.2%
5/41 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
27.3%
3/11 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
8.7%
2/23 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
7.3%
3/41 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
18.2%
2/11 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
13.0%
3/23 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
2.4%
1/41 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
9.1%
1/11 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
|
Metabolism and nutrition disorders
Anorexia
|
17.4%
4/23 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
22.0%
9/41 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
45.5%
5/11 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
|
Gastrointestinal disorders
Constipation
|
8.7%
2/23 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
29.3%
12/41 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
18.2%
2/11 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
|
Metabolism and nutrition disorders
Dehydration
|
8.7%
2/23 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
2.4%
1/41 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
0.00%
0/11 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
|
Gastrointestinal disorders
Diarrhea w/o prior colostomy
|
60.9%
14/23 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
26.8%
11/41 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
36.4%
4/11 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/23 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
9.8%
4/41 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
18.2%
2/11 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
|
Gastrointestinal disorders
Muco/stomatitis by exam, oral cavity
|
4.3%
1/23 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
7.3%
3/41 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
9.1%
1/11 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
|
Gastrointestinal disorders
Nausea
|
47.8%
11/23 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
31.7%
13/41 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
54.5%
6/11 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
|
Gastrointestinal disorders
Taste disturbance
|
4.3%
1/23 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
9.8%
4/41 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
9.1%
1/11 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
|
Gastrointestinal disorders
Vomiting
|
17.4%
4/23 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
22.0%
9/41 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
54.5%
6/11 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
13.0%
3/23 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
4.9%
2/41 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
9.1%
1/11 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
|
Investigations
Alkaline phosphatase increased
|
8.7%
2/23 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
7.3%
3/41 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
0.00%
0/11 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
|
Investigations
Alanine aminotransferase increased (ALT, SGPT)
|
4.3%
1/23 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
7.3%
3/41 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
18.2%
2/11 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
|
Investigations
Aspartate aminotransferase increased (AST, SGOT)
|
8.7%
2/23 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
12.2%
5/41 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
27.3%
3/11 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
8.7%
2/23 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
0.00%
0/41 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
0.00%
0/11 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
|
Investigations
Creatinine increased
|
13.0%
3/23 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
0.00%
0/41 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
9.1%
1/11 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
|
Investigations
Hyperglycemia
|
4.3%
1/23 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
7.3%
3/41 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
0.00%
0/11 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
8.7%
2/23 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
2.4%
1/41 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
0.00%
0/11 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
4.3%
1/23 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
9.8%
4/41 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
0.00%
0/11 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
|
Metabolism and nutrition disorders
Hypokalemia
|
26.1%
6/23 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
7.3%
3/41 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
9.1%
1/11 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
|
Metabolism and nutrition disorders
Hyponatremia
|
34.8%
8/23 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
24.4%
10/41 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
63.6%
7/11 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
|
Nervous system disorders
Dizziness
|
13.0%
3/23 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
9.8%
4/41 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
36.4%
4/11 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/23 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
9.8%
4/41 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
9.1%
1/11 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
|
Nervous system disorders
Neuropathy- sensory
|
21.7%
5/23 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
31.7%
13/41 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
36.4%
4/11 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
|
Eye disorders
Vision blurred
|
8.7%
2/23 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
2.4%
1/41 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
0.00%
0/11 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
|
Gastrointestinal disorders
Abdomen, pain
|
8.7%
2/23 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
4.9%
2/41 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
9.1%
1/11 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
|
Musculoskeletal and connective tissue disorders
Back, pain
|
8.7%
2/23 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
0.00%
0/41 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
0.00%
0/11 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
|
Nervous system disorders
Neuropathic, pain
|
0.00%
0/23 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
7.3%
3/41 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
0.00%
0/11 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
|
Gastrointestinal disorders
Stomach, pain
|
8.7%
2/23 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
0.00%
0/41 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
9.1%
1/11 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/23 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
9.8%
4/41 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
9.1%
1/11 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
8.7%
2/23 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
12.2%
5/41 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
9.1%
1/11 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
0.00%
0/23 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
0.00%
0/41 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
9.1%
1/11 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
|
Cardiac disorders
Palpitations
|
0.00%
0/23 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
0.00%
0/41 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
9.1%
1/11 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
|
Skin and subcutaneous tissue disorders
Sweating
|
0.00%
0/23 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
0.00%
0/41 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
9.1%
1/11 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
|
Investigations
Weight gain
|
0.00%
0/23 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
0.00%
0/41 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
9.1%
1/11 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/23 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
0.00%
0/41 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
9.1%
1/11 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
|
Injury, poisoning and procedural complications
Wound, non-infectious
|
0.00%
0/23 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
0.00%
0/41 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
9.1%
1/11 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/23 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
0.00%
0/41 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
9.1%
1/11 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
|
Gastrointestinal disorders
Gastrointestinal disorders (GI)-other
|
0.00%
0/23 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
0.00%
0/41 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
9.1%
1/11 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
|
Infections and infestations
Infection Gr0-2 neut, upper airway
|
0.00%
0/23 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
0.00%
0/41 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
9.1%
1/11 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
|
Psychiatric disorders
Depression
|
0.00%
0/23 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
0.00%
0/41 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
9.1%
1/11 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
|
Musculoskeletal and connective tissue disorders
Bone, pain
|
0.00%
0/23 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
0.00%
0/41 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
9.1%
1/11 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
|
Nervous system disorders
Head/headache
|
0.00%
0/23 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
0.00%
0/41 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
9.1%
1/11 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
|
Musculoskeletal and connective tissue disorders
Muscle, pain
|
0.00%
0/23 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
0.00%
0/41 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
9.1%
1/11 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
|
Musculoskeletal and connective tissue disorders
Neck, pain
|
0.00%
0/23 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
0.00%
0/41 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
9.1%
1/11 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
|
Respiratory, thoracic and mediastinal disorders
Throat/pharynx/larynx, pain
|
0.00%
0/23 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
0.00%
0/41 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
9.1%
1/11 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
|
Renal and urinary disorders
Urethra, pain
|
0.00%
0/23 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
0.00%
0/41 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
9.1%
1/11 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
|
Respiratory, thoracic and mediastinal disorders
Voice change/dysarthria
|
0.00%
0/23 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
0.00%
0/41 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
9.1%
1/11 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
|
General disorders
Edema head and neck
|
0.00%
0/23 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
0.00%
0/41 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
9.1%
1/11 • Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
|
Additional Information
ECOG Statistician
Eastern Cooperative Oncology Group (ECOG) Statistical Office
Phone: 617-632-3012
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60