Trial Outcomes & Findings for Phase 2 Etirinotecan Pegol in Refractory Brain Metastases & Advanced Lung Cancer / Metastatic Breast Cancer (NCT NCT02312622)
NCT ID: NCT02312622
Last Updated: 2023-12-12
Results Overview
Central nervous system (CNS) disease control (DC) is defined as a complete response (CR); partial response (PR); or stable disease (SD). The outcome is reported as the number and percentage of participants who achieve DC, a number without dispersion. Response criteria are as follows. Note that any lesion less than 10 mm in longest diameter (LD) is considered unchanged unless there is a ≥ 3 mm change in the sum of the LDs. * CR = Disappearance of all target lesions, sustained for ≥ 4 weeks with no new lesions; clinical condition stable or improved * PR = ≥ 30% decrease in target lesion LD and no new lesions, sustained for ≥ 4 weeks; clinical condition stable or improved * PD (progressive disease) = Any of 20% increase in target lesion LD; increase in T2/FLAIR non-enhancing lesions; any new lesions; non-target progression; or clinical deterioration * SD = Neither PR or PD
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
27 participants
Primary outcome timeframe
At 12 weeks
Results posted on
2023-12-12
Participant Flow
Participant milestones
| Measure |
Cohort A - Pegylated Irinotecan to Treat NSCLC
Patients with non-small cell lung carinoma (NSCLC) will receive pegylated irinotecan NKTR 102 IV over 90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.
Pegylated Irinotecan: Administered intravenously (IV) at 145 mg/m² as monotherapy once every 21 days (1 cycle)
|
Cohort B - Pegylated Irinotecan to Treat SCLC
Patients with small cell lung carinoma (SCLC) will receive pegylated irinotecan NKTR 102 IV over 90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.
Pegylated Irinotecan: Administered intravenously (IV) at 145 mg/m² as monotherapy once every 21 days (1 cycle)
|
Cohort C - Pegylated Irinotecan to Treat mBC
Patients with metastatic breast cancer (MBC) to brain will receive pegylated irinotecan NKTR 102 IV over 90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.
Pegylated Irinotecan: Administered intravenously (IV) at 145 mg/m² as monotherapy once every 21 days (1 cycle)
|
|---|---|---|---|
|
Overall Study
STARTED
|
12
|
3
|
12
|
|
Overall Study
COMPLETED
|
12
|
3
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase 2 Etirinotecan Pegol in Refractory Brain Metastases & Advanced Lung Cancer / Metastatic Breast Cancer
Baseline characteristics by cohort
| Measure |
Cohort A - Pegylated Irinotecan to Treat NSCLC
n=12 Participants
Patients with non-small cell lung carinoma (NSCLC) will receive pegylated irinotecan intravenously (IV) over 90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.
Pegylated Irinotecan: Administered intravenously (IV) at 145 mg/m² as monotherapy once every 21 days (1 cycle)
|
Cohort B - Pegylated Irinotecan to Treat SCLC
n=3 Participants
Patients with small cell lung carinoma (SCLC) will receive pegylated irinotecan intravenously (IV) over 90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.
Pegylated Irinotecan: Administered intravenously (IV) at 145 mg/m² as monotherapy once every 21 days (1 cycle)
|
Cohort C - Pegylated Irinotecan to Treat mBC
n=12 Participants
Patients with metastatic breast cancer (MBC) to brain will receive pegylated irinotecan intravenously (IV) over 90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.
Pegylated Irinotecan: Administered intravenously (IV) at 145 mg/m² as monotherapy once every 21 days (1 cycle)
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
3 participants
n=7 Participants
|
12 participants
n=5 Participants
|
27 participants
n=4 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Age, Continuous
|
56.3 years
STANDARD_DEVIATION 13.2 • n=5 Participants
|
63.3 years
STANDARD_DEVIATION 15.5 • n=7 Participants
|
48.2 years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
53.5 years
STANDARD_DEVIATION 13.1 • n=4 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
9 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: At 12 weeksPopulation: Cohort B (metastatic small cell lung cancer, SCLC) is excluded per protocol from this outcome.
Central nervous system (CNS) disease control (DC) is defined as a complete response (CR); partial response (PR); or stable disease (SD). The outcome is reported as the number and percentage of participants who achieve DC, a number without dispersion. Response criteria are as follows. Note that any lesion less than 10 mm in longest diameter (LD) is considered unchanged unless there is a ≥ 3 mm change in the sum of the LDs. * CR = Disappearance of all target lesions, sustained for ≥ 4 weeks with no new lesions; clinical condition stable or improved * PR = ≥ 30% decrease in target lesion LD and no new lesions, sustained for ≥ 4 weeks; clinical condition stable or improved * PD (progressive disease) = Any of 20% increase in target lesion LD; increase in T2/FLAIR non-enhancing lesions; any new lesions; non-target progression; or clinical deterioration * SD = Neither PR or PD
Outcome measures
| Measure |
Cohort A - Pegylated Irinotecan to Treat NSCLC
n=12 Participants
Patients with non-small cell lung carinoma (NSCLC) will receive pegylated irinotecan intravenously (IV) over 90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.
Pegylated Irinotecan: Administered intravenously (IV) at 145 mg/m² as monotherapy once every 21 days (1 cycle)
|
Cohort C - Pegylated Irinotecan to Treat mBC
n=12 Participants
Patients with metastatic breast cancer (MBC) to brain will receive pegylated irinotecan intravenously (IV) over 90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.
Pegylated Irinotecan: Administered intravenously (IV) at 145 mg/m² as monotherapy once every 21 days (1 cycle)
|
Cohort C - Pegylated Irinotecan to Treat mBC
Patients with metastatic breast cancer (MBC) to brain will receive pegylated irinotecan intravenously (IV) over 90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.
Pegylated Irinotecan: Administered intravenously (IV) at 145 mg/m² as monotherapy once every 21 days (1 cycle)
|
|---|---|---|---|
|
Central Nervous System (CNS) Disease Control Rate (Cohort A and C)
|
2 Participants
|
2 Participants
|
—
|
SECONDARY outcome
Timeframe: At 12 weeksPopulation: Cohort B (metastatic small cell lung cancer, SCLC) is excluded per protocol from this outcome.
Overall disease control (DC) rate is defined as the sum in a cohort of the numbers of participants achieving complete response (CR); partial response (PR); or stable disease (SD), divided by the number of patients in that cohort. For this outcome, "overall" means all body systems, not just the central nervous system (CNS). The outcome is reported as DC rate, a number without dispersion. Response criteria are as follows. Note that any lesion \<10 mm in longest diameter (LD) is considered unchanged unless there is a ≥3 mm change in the sum of the LDs. * CR = Disappearance of all target lesions, sustained for ≥4 weeks with no new lesions; clinical condition stable or improved * PR = ≥30% decrease in target lesion LD \& no new lesions, sustained for ≥ 4 weeks; clinical condition stable or improved * PD = Any of: 20% increase in target lesion LD; increase in T2/FLAIR non-enhancing lesions; any new lesions; non-target progression; or clinical deterioration * SD = Neither PR or PD
Outcome measures
| Measure |
Cohort A - Pegylated Irinotecan to Treat NSCLC
n=12 Participants
Patients with non-small cell lung carinoma (NSCLC) will receive pegylated irinotecan intravenously (IV) over 90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.
Pegylated Irinotecan: Administered intravenously (IV) at 145 mg/m² as monotherapy once every 21 days (1 cycle)
|
Cohort C - Pegylated Irinotecan to Treat mBC
n=12 Participants
Patients with metastatic breast cancer (MBC) to brain will receive pegylated irinotecan intravenously (IV) over 90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.
Pegylated Irinotecan: Administered intravenously (IV) at 145 mg/m² as monotherapy once every 21 days (1 cycle)
|
Cohort C - Pegylated Irinotecan to Treat mBC
Patients with metastatic breast cancer (MBC) to brain will receive pegylated irinotecan intravenously (IV) over 90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.
Pegylated Irinotecan: Administered intravenously (IV) at 145 mg/m² as monotherapy once every 21 days (1 cycle)
|
|---|---|---|---|
|
Overall Disease Control Rate (Cohort A and C)
|
2 participants
|
2 participants
|
—
|
SECONDARY outcome
Timeframe: At 12 weeksPopulation: Cohort B (metastatic small cell lung cancer, SCLC) is excluded per protocol from this outcome.
Overall response by subject (OR) is defined as the lower assessment between the central nervous system response and the systemic response. Response is defined as either complete response (CR) or partial response (PR). The outcome is reported as the number and percentage of participants who achieve OR, a number without dispersion. Response criteria are as follows. Note that any lesion \< 10 mm in longest diameter (LD) is considered unchanged unless there is a ≥ 3 mm change in the sum of the LDs. * CR = Disappearance of all lesions, sustained for ≥ 4 weeks with no new lesions; clinical condition stable or improved * PR = ≥ 30% decrease in target lesion LD \& no new lesions, sustained for ≥ 4 weeks; clinical condition stable or improved * PD = Any of: 20% increase in target lesion LD; increase in T2/FLAIR non-enhancing lesions; any new lesions; non-target progression; or clinical deterioration * SD = Neither PR or PD
Outcome measures
| Measure |
Cohort A - Pegylated Irinotecan to Treat NSCLC
n=12 Participants
Patients with non-small cell lung carinoma (NSCLC) will receive pegylated irinotecan intravenously (IV) over 90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.
Pegylated Irinotecan: Administered intravenously (IV) at 145 mg/m² as monotherapy once every 21 days (1 cycle)
|
Cohort C - Pegylated Irinotecan to Treat mBC
n=12 Participants
Patients with metastatic breast cancer (MBC) to brain will receive pegylated irinotecan intravenously (IV) over 90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.
Pegylated Irinotecan: Administered intravenously (IV) at 145 mg/m² as monotherapy once every 21 days (1 cycle)
|
Cohort C - Pegylated Irinotecan to Treat mBC
Patients with metastatic breast cancer (MBC) to brain will receive pegylated irinotecan intravenously (IV) over 90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.
Pegylated Irinotecan: Administered intravenously (IV) at 145 mg/m² as monotherapy once every 21 days (1 cycle)
|
|---|---|---|---|
|
Overall Response Rate (Cohort A and C)
|
1 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: At 12 weeksPopulation: Cohort B (metastatic small cell lung cancer, SCLC) is excluded per protocol from this outcome.
Systemic (ie, non-central nervous system) disease control (DC) rate by cohort is defined as the number of patients with complete response (CR) + partial response (PR) + stable disease (SD), divided by the total number of patients. The outcome will be reported as DC rate, a number without dispersion. Response criteria are as follows. Note that any lesion \< 10 mm in longest diameter (LD) is considered unchanged unless there is a ≥ 3 mm change in the sum of the LDs. * CR = Disappearance of all lesions, no new lesions; pathological lymph nodes reduced in short axis to \< 10 mm * PR = ≥ 30% decrease in sum of lesion diameters; no new lesions; no progression of non-target lesions * PD = Any of 20% increase in sum of lesion diameters; progression of non-target lesions; new lesions * SD = Neither CR, PR, nor PD
Outcome measures
| Measure |
Cohort A - Pegylated Irinotecan to Treat NSCLC
n=12 Participants
Patients with non-small cell lung carinoma (NSCLC) will receive pegylated irinotecan intravenously (IV) over 90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.
Pegylated Irinotecan: Administered intravenously (IV) at 145 mg/m² as monotherapy once every 21 days (1 cycle)
|
Cohort C - Pegylated Irinotecan to Treat mBC
n=12 Participants
Patients with metastatic breast cancer (MBC) to brain will receive pegylated irinotecan intravenously (IV) over 90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.
Pegylated Irinotecan: Administered intravenously (IV) at 145 mg/m² as monotherapy once every 21 days (1 cycle)
|
Cohort C - Pegylated Irinotecan to Treat mBC
Patients with metastatic breast cancer (MBC) to brain will receive pegylated irinotecan intravenously (IV) over 90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.
Pegylated Irinotecan: Administered intravenously (IV) at 145 mg/m² as monotherapy once every 21 days (1 cycle)
|
|---|---|---|---|
|
Systemic (Non-CNS) Disease Control Rate (Cohort A and C)
|
3 Participants
|
3 Participants
|
—
|
SECONDARY outcome
Timeframe: At 12 weeksPopulation: Cohort B (metastatic small cell lung cancer, SCLC) is excluded per protocol from this outcome.
Systemic (ie, non-central nervous system) response rate by cohort is defined as the number of participants achieving a complete response (CR) or partial response (PR), divided by the number of participants. The outcome will be reported as a number without dispersion. Response criteria are as follows. Note that any lesion \< 10 mm in longest diameter (LD) is considered unchanged unless there is a ≥ 3 mm change in the sum of the LDs. * CR = Disappearance of all target lesions, no new lesions; pathological lymph nodes reduced in short axis to \< 10 mm * PR = ≥ 30% decrease in sum of lesion diameters; no new lesions; no progression of non-target lesions * PD = Any of 20% increase in sum of lesion diameters; progression of non-target lesions; new lesions * SD = Neither CR, PR, nor PD
Outcome measures
| Measure |
Cohort A - Pegylated Irinotecan to Treat NSCLC
n=12 Participants
Patients with non-small cell lung carinoma (NSCLC) will receive pegylated irinotecan intravenously (IV) over 90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.
Pegylated Irinotecan: Administered intravenously (IV) at 145 mg/m² as monotherapy once every 21 days (1 cycle)
|
Cohort C - Pegylated Irinotecan to Treat mBC
n=12 Participants
Patients with metastatic breast cancer (MBC) to brain will receive pegylated irinotecan intravenously (IV) over 90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.
Pegylated Irinotecan: Administered intravenously (IV) at 145 mg/m² as monotherapy once every 21 days (1 cycle)
|
Cohort C - Pegylated Irinotecan to Treat mBC
Patients with metastatic breast cancer (MBC) to brain will receive pegylated irinotecan intravenously (IV) over 90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.
Pegylated Irinotecan: Administered intravenously (IV) at 145 mg/m² as monotherapy once every 21 days (1 cycle)
|
|---|---|---|---|
|
Systemic (Non-CNS) Response Rate (Cohort A and C)
|
1 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Date of first dose of pegylated irinotecan NKTR 102 to date of disease progression, assessed up to 2 yearsPopulation: Cohort B (metastatic small cell lung cancer, SCLC) is excluded per protocol from this outcome.
Progression-free survival (PFS) is defined as the time from the date of start of treatment until disease progression or death. The outcome is reported by cohort as PFS in months, with full range.
Outcome measures
| Measure |
Cohort A - Pegylated Irinotecan to Treat NSCLC
n=12 Participants
Patients with non-small cell lung carinoma (NSCLC) will receive pegylated irinotecan intravenously (IV) over 90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.
Pegylated Irinotecan: Administered intravenously (IV) at 145 mg/m² as monotherapy once every 21 days (1 cycle)
|
Cohort C - Pegylated Irinotecan to Treat mBC
n=12 Participants
Patients with metastatic breast cancer (MBC) to brain will receive pegylated irinotecan intravenously (IV) over 90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.
Pegylated Irinotecan: Administered intravenously (IV) at 145 mg/m² as monotherapy once every 21 days (1 cycle)
|
Cohort C - Pegylated Irinotecan to Treat mBC
Patients with metastatic breast cancer (MBC) to brain will receive pegylated irinotecan intravenously (IV) over 90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.
Pegylated Irinotecan: Administered intravenously (IV) at 145 mg/m² as monotherapy once every 21 days (1 cycle)
|
|---|---|---|---|
|
Progression-free Survival (PFS) (Cohort A and C)
|
2.66 months
Interval 1.35 to 6.74
|
1.35 months
Interval 1.31 to 6.88
|
—
|
SECONDARY outcome
Timeframe: 4 yearsPopulation: Cohort B (metastatic small cell lung cancer, SCLC) is excluded per protocol from this outcome.
Overall survival (OS) is defined as the period remaining alive after the start of treatment. The outcome is reported as the median with full range.
Outcome measures
| Measure |
Cohort A - Pegylated Irinotecan to Treat NSCLC
n=12 Participants
Patients with non-small cell lung carinoma (NSCLC) will receive pegylated irinotecan intravenously (IV) over 90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.
Pegylated Irinotecan: Administered intravenously (IV) at 145 mg/m² as monotherapy once every 21 days (1 cycle)
|
Cohort C - Pegylated Irinotecan to Treat mBC
n=12 Participants
Patients with metastatic breast cancer (MBC) to brain will receive pegylated irinotecan intravenously (IV) over 90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.
Pegylated Irinotecan: Administered intravenously (IV) at 145 mg/m² as monotherapy once every 21 days (1 cycle)
|
Cohort C - Pegylated Irinotecan to Treat mBC
Patients with metastatic breast cancer (MBC) to brain will receive pegylated irinotecan intravenously (IV) over 90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.
Pegylated Irinotecan: Administered intravenously (IV) at 145 mg/m² as monotherapy once every 21 days (1 cycle)
|
|---|---|---|---|
|
Overall Survival (Cohort A and C)
|
7.00 months
Interval 5.13 to 48.0
|
8.49 months
Interval 1.94 to 21.84
|
—
|
SECONDARY outcome
Timeframe: At 12 weeksPopulation: This outcome was restricted by protocol to Cohort B.
Central nervous system (CNS) disease control (DC) is defined as a complete response (CR); partial response (PR); or stable disease (SD). The outcome is reported as the number and percentage of participants who achieve DC, a number without dispersion. Response criteria are as follows. Note that any lesion less than 10 mm in longest diameter (LD) is considered unchanged unless there is a ≥ 3 mm change in the sum of the LDs. * CR = Disappearance of all target lesions, sustained for ≥ 4 weeks with no new lesions; clinical condition stable or improved * PR = ≥ 30% decrease in target lesion LD and no new lesions, sustained for ≥ 4 weeks; clinical condition stable or improved * PD = Any of 20% increase in target lesion LD; increase in T2/FLAIR non-enhancing lesions; any new lesions; non-target progression; or clinical deterioration * SD = Neither PR or PD
Outcome measures
| Measure |
Cohort A - Pegylated Irinotecan to Treat NSCLC
n=3 Participants
Patients with non-small cell lung carinoma (NSCLC) will receive pegylated irinotecan intravenously (IV) over 90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.
Pegylated Irinotecan: Administered intravenously (IV) at 145 mg/m² as monotherapy once every 21 days (1 cycle)
|
Cohort C - Pegylated Irinotecan to Treat mBC
Patients with metastatic breast cancer (MBC) to brain will receive pegylated irinotecan intravenously (IV) over 90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.
Pegylated Irinotecan: Administered intravenously (IV) at 145 mg/m² as monotherapy once every 21 days (1 cycle)
|
Cohort C - Pegylated Irinotecan to Treat mBC
Patients with metastatic breast cancer (MBC) to brain will receive pegylated irinotecan intravenously (IV) over 90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.
Pegylated Irinotecan: Administered intravenously (IV) at 145 mg/m² as monotherapy once every 21 days (1 cycle)
|
|---|---|---|---|
|
Central Nervous System (CNS) Disease Control (Cohort B)
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: At 12 weeksPopulation: This outcome was restricted by protocol to Cohort B.
Systemic (ie, non-central nervous system) disease control (DC) rate by cohort is defined as the number of patients with complete response (CR) + partial response (PR) + stable disease (SD), divided by the total number of patients. The outcome will be reported as DC rate, a number without dispersion. Response criteria are as follows. Note that any lesion \< 10 mm in longest diameter (LD) is considered unchanged unless there is a ≥ 3 mm change in the sum of the LDs. * CR = Disappearance of all lesions, no new lesions; pathological lymph nodes reduced in short axis to \< 10 mm * PR = ≥ 30% decrease in sum of lesion diameters; no new lesions; no progression of non-target lesions * PD = Any of 20% increase in sum of lesion diameters; progression of non-target lesions; new lesions * SD = Neither CR, PR, nor PD
Outcome measures
| Measure |
Cohort A - Pegylated Irinotecan to Treat NSCLC
n=3 Participants
Patients with non-small cell lung carinoma (NSCLC) will receive pegylated irinotecan intravenously (IV) over 90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.
Pegylated Irinotecan: Administered intravenously (IV) at 145 mg/m² as monotherapy once every 21 days (1 cycle)
|
Cohort C - Pegylated Irinotecan to Treat mBC
Patients with metastatic breast cancer (MBC) to brain will receive pegylated irinotecan intravenously (IV) over 90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.
Pegylated Irinotecan: Administered intravenously (IV) at 145 mg/m² as monotherapy once every 21 days (1 cycle)
|
Cohort C - Pegylated Irinotecan to Treat mBC
Patients with metastatic breast cancer (MBC) to brain will receive pegylated irinotecan intravenously (IV) over 90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.
Pegylated Irinotecan: Administered intravenously (IV) at 145 mg/m² as monotherapy once every 21 days (1 cycle)
|
|---|---|---|---|
|
Systemic Disease Control (Cohort B)
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: All participants are included.
Toxicity, defined as related adverse events, is reported as the total number of events experienced by the participants in each cohort, a number without dispersion. Related is defined as meaning possibly, probably, or definitely related to the study drug.
Outcome measures
| Measure |
Cohort A - Pegylated Irinotecan to Treat NSCLC
n=12 Participants
Patients with non-small cell lung carinoma (NSCLC) will receive pegylated irinotecan intravenously (IV) over 90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.
Pegylated Irinotecan: Administered intravenously (IV) at 145 mg/m² as monotherapy once every 21 days (1 cycle)
|
Cohort C - Pegylated Irinotecan to Treat mBC
n=3 Participants
Patients with metastatic breast cancer (MBC) to brain will receive pegylated irinotecan intravenously (IV) over 90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.
Pegylated Irinotecan: Administered intravenously (IV) at 145 mg/m² as monotherapy once every 21 days (1 cycle)
|
Cohort C - Pegylated Irinotecan to Treat mBC
n=12 Participants
Patients with metastatic breast cancer (MBC) to brain will receive pegylated irinotecan intravenously (IV) over 90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.
Pegylated Irinotecan: Administered intravenously (IV) at 145 mg/m² as monotherapy once every 21 days (1 cycle)
|
|---|---|---|---|
|
Related Adverse Events (Toxicity)
|
70 adverse events
|
40 adverse events
|
68 adverse events
|
Adverse Events
Cohort A - Pegylated Irinotecan to Treat NSCLC
Serious events: 12 serious events
Other events: 12 other events
Deaths: 11 deaths
Cohort B - Pegylated Irinotecan to Treat SCLC
Serious events: 3 serious events
Other events: 3 other events
Deaths: 3 deaths
Cohort C - Pegylated Irinotecan to Treat mBC
Serious events: 6 serious events
Other events: 12 other events
Deaths: 11 deaths
Serious adverse events
| Measure |
Cohort A - Pegylated Irinotecan to Treat NSCLC
n=12 participants at risk
Patients with non-small cell lung carinoma (NSCLC) will receive pegylated irinotecan intravenously (IV) over 90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.
Pegylated Irinotecan: Administered intravenously (IV) at 145 mg/m² as monotherapy once every 21 days (1 cycle)
|
Cohort B - Pegylated Irinotecan to Treat SCLC
n=3 participants at risk
Patients with small cell lung carinoma (SCLC) will receive pegylated irinotecan intravenously (IV) over 90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.
Pegylated Irinotecan: Administered intravenously (IV) at 145 mg/m² as monotherapy once every 21 days (1 cycle)
|
Cohort C - Pegylated Irinotecan to Treat mBC
n=12 participants at risk
Patients with metastatic breast cancer (MBC) to brain will receive pegylated irinotecan intravenously (IV) over 90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.
Pegylated Irinotecan: Administered intravenously (IV) at 145 mg/m² as monotherapy once every 21 days (1 cycle)
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/12 • 2 years
|
66.7%
2/3 • Number of events 2 • 2 years
|
0.00%
0/12 • 2 years
|
|
Cardiac disorders
Pericardial tamponade
|
8.3%
1/12 • Number of events 1 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/12 • 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/12 • 2 years
|
33.3%
1/3 • Number of events 1 • 2 years
|
0.00%
0/12 • 2 years
|
|
General disorders
Non-cardiac chest pain
|
8.3%
1/12 • Number of events 1 • 2 years
|
0.00%
0/3 • 2 years
|
8.3%
1/12 • Number of events 1 • 2 years
|
|
Infections and infestations
Sepsis
|
0.00%
0/12 • 2 years
|
33.3%
1/3 • Number of events 1 • 2 years
|
8.3%
1/12 • Number of events 1 • 2 years
|
|
Infections and infestations
Respiratory infection
|
8.3%
1/12 • Number of events 1 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/12 • 2 years
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/12 • 2 years
|
0.00%
0/3 • 2 years
|
8.3%
1/12 • Number of events 1 • 2 years
|
|
Metabolism and nutrition disorders
Dehydration
|
16.7%
2/12 • Number of events 2 • 2 years
|
33.3%
1/3 • Number of events 1 • 2 years
|
0.00%
0/12 • 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Disease progression
|
8.3%
1/12 • Number of events 1 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/12 • 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous Cell Carcinoma
|
0.00%
0/12 • 2 years
|
0.00%
0/3 • 2 years
|
8.3%
1/12 • Number of events 1 • 2 years
|
|
Nervous system disorders
Edema cerebral
|
8.3%
1/12 • Number of events 1 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/12 • 2 years
|
|
Nervous system disorders
Intracranial hemorrhage
|
8.3%
1/12 • Number of events 1 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/12 • 2 years
|
|
Nervous system disorders
Seizure
|
8.3%
1/12 • Number of events 1 • 2 years
|
0.00%
0/3 • 2 years
|
8.3%
1/12 • Number of events 1 • 2 years
|
|
Nervous system disorders
Stroke
|
0.00%
0/12 • 2 years
|
33.3%
1/3 • Number of events 1 • 2 years
|
0.00%
0/12 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
8.3%
1/12 • Number of events 1 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/12 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
8.3%
1/12 • Number of events 1 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/12 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
8.3%
1/12 • Number of events 1 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/12 • 2 years
|
|
Vascular disorders
Thromboembolic event
|
8.3%
1/12 • Number of events 1 • 2 years
|
0.00%
0/3 • 2 years
|
8.3%
1/12 • Number of events 1 • 2 years
|
|
Cardiac disorders
Pericardial Effusion
|
8.3%
1/12 • Number of events 1 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/12 • 2 years
|
|
Infections and infestations
Septic Shock
|
0.00%
0/12 • 2 years
|
33.3%
1/3 • Number of events 1 • 2 years
|
8.3%
1/12 • Number of events 1 • 2 years
|
Other adverse events
| Measure |
Cohort A - Pegylated Irinotecan to Treat NSCLC
n=12 participants at risk
Patients with non-small cell lung carinoma (NSCLC) will receive pegylated irinotecan intravenously (IV) over 90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.
Pegylated Irinotecan: Administered intravenously (IV) at 145 mg/m² as monotherapy once every 21 days (1 cycle)
|
Cohort B - Pegylated Irinotecan to Treat SCLC
n=3 participants at risk
Patients with small cell lung carinoma (SCLC) will receive pegylated irinotecan intravenously (IV) over 90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.
Pegylated Irinotecan: Administered intravenously (IV) at 145 mg/m² as monotherapy once every 21 days (1 cycle)
|
Cohort C - Pegylated Irinotecan to Treat mBC
n=12 participants at risk
Patients with metastatic breast cancer (MBC) to brain will receive pegylated irinotecan intravenously (IV) over 90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.
Pegylated Irinotecan: Administered intravenously (IV) at 145 mg/m² as monotherapy once every 21 days (1 cycle)
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
16.7%
2/12 • Number of events 2 • 2 years
|
0.00%
0/3 • 2 years
|
8.3%
1/12 • Number of events 3 • 2 years
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.00%
0/12 • 2 years
|
33.3%
1/3 • Number of events 1 • 2 years
|
0.00%
0/12 • 2 years
|
|
Psychiatric disorders
Agitation
|
0.00%
0/12 • 2 years
|
33.3%
1/3 • Number of events 1 • 2 years
|
0.00%
0/12 • 2 years
|
|
Immune system disorders
Allergic Reaction
|
8.3%
1/12 • Number of events 1 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/12 • 2 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
8.3%
1/12 • Number of events 1 • 2 years
|
33.3%
1/3 • Number of events 2 • 2 years
|
0.00%
0/12 • 2 years
|
|
Gastrointestinal disorders
Anal Hemorrhage
|
0.00%
0/12 • 2 years
|
0.00%
0/3 • 2 years
|
8.3%
1/12 • Number of events 1 • 2 years
|
|
Blood and lymphatic system disorders
Anemia
|
8.3%
1/12 • Number of events 1 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/12 • 2 years
|
|
Metabolism and nutrition disorders
Anorexia
|
16.7%
2/12 • Number of events 2 • 2 years
|
0.00%
0/3 • 2 years
|
8.3%
1/12 • Number of events 1 • 2 years
|
|
Nervous system disorders
Ataxia
|
8.3%
1/12 • Number of events 1 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/12 • 2 years
|
|
Cardiac disorders
Atrial Fibrillations
|
0.00%
0/12 • 2 years
|
33.3%
1/3 • Number of events 1 • 2 years
|
0.00%
0/12 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
25.0%
3/12 • Number of events 3 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/12 • 2 years
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/12 • 2 years
|
0.00%
0/3 • 2 years
|
8.3%
1/12 • Number of events 1 • 2 years
|
|
Eye disorders
Blurred vision
|
25.0%
3/12 • Number of events 4 • 2 years
|
33.3%
1/3 • Number of events 2 • 2 years
|
16.7%
2/12 • Number of events 2 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Body Ache
|
0.00%
0/12 • 2 years
|
0.00%
0/3 • 2 years
|
8.3%
1/12 • Number of events 1 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
0.00%
0/12 • 2 years
|
0.00%
0/3 • 2 years
|
8.3%
1/12 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/12 • 2 years
|
33.3%
1/3 • Number of events 1 • 2 years
|
0.00%
0/12 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/12 • 2 years
|
0.00%
0/3 • 2 years
|
16.7%
2/12 • Number of events 2 • 2 years
|
|
Cardiac disorders
Cardiogenic Shock
|
0.00%
0/12 • 2 years
|
33.3%
1/3 • Number of events 1 • 2 years
|
0.00%
0/12 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Chest Wall Pain
|
8.3%
1/12 • Number of events 1 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/12 • 2 years
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/12 • 2 years
|
33.3%
1/3 • Number of events 1 • 2 years
|
0.00%
0/12 • 2 years
|
|
Psychiatric disorders
Confusion
|
16.7%
2/12 • Number of events 2 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/12 • 2 years
|
|
Gastrointestinal disorders
Constipation
|
16.7%
2/12 • Number of events 2 • 2 years
|
33.3%
1/3 • Number of events 1 • 2 years
|
25.0%
3/12 • Number of events 5 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/12 • 2 years
|
100.0%
3/3 • Number of events 3 • 2 years
|
0.00%
0/12 • 2 years
|
|
Psychiatric disorders
Delirium
|
0.00%
0/12 • 2 years
|
33.3%
1/3 • Number of events 1 • 2 years
|
8.3%
1/12 • Number of events 1 • 2 years
|
|
Injury, poisoning and procedural complications
Dermatitis Radiation
|
0.00%
0/12 • 2 years
|
0.00%
0/3 • 2 years
|
8.3%
1/12 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
41.7%
5/12 • Number of events 26 • 2 years
|
100.0%
3/3 • Number of events 9 • 2 years
|
41.7%
5/12 • Number of events 25 • 2 years
|
|
Eye disorders
Double vision
|
0.00%
0/12 • 2 years
|
0.00%
0/3 • 2 years
|
16.7%
2/12 • Number of events 2 • 2 years
|
|
Nervous system disorders
Dysgeusia
|
8.3%
1/12 • Number of events 1 • 2 years
|
33.3%
1/3 • Number of events 2 • 2 years
|
8.3%
1/12 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/12 • 2 years
|
0.00%
0/3 • 2 years
|
16.7%
2/12 • Number of events 2 • 2 years
|
|
Nervous system disorders
Dysphasia
|
8.3%
1/12 • Number of events 1 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/12 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
16.7%
2/12 • Number of events 2 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/12 • 2 years
|
|
General disorders
Edema Face
|
8.3%
1/12 • Number of events 1 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/12 • 2 years
|
|
General disorders
Edema Limbs
|
8.3%
1/12 • Number of events 1 • 2 years
|
0.00%
0/3 • 2 years
|
8.3%
1/12 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
8.3%
1/12 • Number of events 1 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/12 • 2 years
|
|
Eye disorders
Eye Pain
|
8.3%
1/12 • Number of events 1 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/12 • 2 years
|
|
Injury, poisoning and procedural complications
Fall
|
8.3%
1/12 • Number of events 1 • 2 years
|
0.00%
0/3 • 2 years
|
16.7%
2/12 • Number of events 2 • 2 years
|
|
General disorders
Fatigue
|
0.00%
0/12 • 2 years
|
66.7%
2/3 • Number of events 5 • 2 years
|
41.7%
5/12 • Number of events 7 • 2 years
|
|
Vascular disorders
Flushing
|
8.3%
1/12 • Number of events 1 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/12 • 2 years
|
|
Injury, poisoning and procedural complications
Fracture
|
8.3%
1/12 • Number of events 1 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/12 • 2 years
|
|
General disorders
Gait disturbance
|
8.3%
1/12 • Number of events 1 • 2 years
|
0.00%
0/3 • 2 years
|
8.3%
1/12 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/12 • 2 years
|
0.00%
0/3 • 2 years
|
8.3%
1/12 • Number of events 1 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/12 • 2 years
|
0.00%
0/3 • 2 years
|
16.7%
2/12 • Number of events 2 • 2 years
|
|
Nervous system disorders
Headache
|
16.7%
2/12 • Number of events 4 • 2 years
|
0.00%
0/3 • 2 years
|
25.0%
3/12 • Number of events 4 • 2 years
|
|
Gastrointestinal disorders
Hemorrhoids
|
8.3%
1/12 • Number of events 1 • 2 years
|
0.00%
0/3 • 2 years
|
8.3%
1/12 • Number of events 1 • 2 years
|
|
General disorders
Infusion Related reaction
|
8.3%
1/12 • Number of events 2 • 2 years
|
0.00%
0/3 • 2 years
|
8.3%
1/12 • Number of events 2 • 2 years
|
|
General disorders
Infusion site extravasation
|
0.00%
0/12 • 2 years
|
0.00%
0/3 • 2 years
|
8.3%
1/12 • Number of events 1 • 2 years
|
|
General disorders
Malaise
|
0.00%
0/12 • 2 years
|
0.00%
0/3 • 2 years
|
8.3%
1/12 • Number of events 1 • 2 years
|
|
Nervous system disorders
Memory Impairment
|
0.00%
0/12 • 2 years
|
33.3%
1/3 • Number of events 1 • 2 years
|
8.3%
1/12 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Nausea
|
58.3%
7/12 • Number of events 13 • 2 years
|
66.7%
2/3 • Number of events 4 • 2 years
|
33.3%
4/12 • Number of events 6 • 2 years
|
|
General disorders
Non Cardiac Pain
|
0.00%
0/12 • 2 years
|
0.00%
0/3 • 2 years
|
8.3%
1/12 • Number of events 1 • 2 years
|
|
Infections and infestations
Oral Thrush
|
0.00%
0/12 • 2 years
|
0.00%
0/3 • 2 years
|
8.3%
1/12 • Number of events 1 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/12 • 2 years
|
0.00%
0/3 • 2 years
|
8.3%
1/12 • Number of events 2 • 2 years
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/12 • 2 years
|
33.3%
1/3 • Number of events 1 • 2 years
|
0.00%
0/12 • 2 years
|
|
Eye disorders
Photophobia
|
25.0%
3/12 • Number of events 4 • 2 years
|
33.3%
1/3 • Number of events 2 • 2 years
|
8.3%
1/12 • Number of events 1 • 2 years
|
|
Eye disorders
Pupil Constriction
|
0.00%
0/12 • 2 years
|
0.00%
0/3 • 2 years
|
8.3%
1/12 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Rectal Pain
|
0.00%
0/12 • 2 years
|
0.00%
0/3 • 2 years
|
8.3%
1/12 • Number of events 1 • 2 years
|
|
Eye disorders
Right Eye Redness
|
0.00%
0/12 • 2 years
|
0.00%
0/3 • 2 years
|
8.3%
1/12 • Number of events 1 • 2 years
|
|
Nervous system disorders
Seizure
|
0.00%
0/12 • 2 years
|
0.00%
0/3 • 2 years
|
8.3%
1/12 • Number of events 1 • 2 years
|
|
Injury, poisoning and procedural complications
Spinal Fracture
|
0.00%
0/12 • 2 years
|
0.00%
0/3 • 2 years
|
8.3%
1/12 • Number of events 1 • 2 years
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/12 • 2 years
|
0.00%
0/3 • 2 years
|
16.7%
2/12 • Number of events 3 • 2 years
|
|
Cardiac disorders
Ventricular Tachycardia
|
0.00%
0/12 • 2 years
|
0.00%
0/3 • 2 years
|
8.3%
1/12 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
4/12 • Number of events 14 • 2 years
|
33.3%
1/3 • Number of events 1 • 2 years
|
25.0%
3/12 • Number of events 4 • 2 years
|
|
Investigations
Weight Loss
|
8.3%
1/12 • Number of events 1 • 2 years
|
0.00%
0/3 • 2 years
|
8.3%
1/12 • Number of events 2 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/12 • 2 years
|
66.7%
2/3 • Number of events 2 • 2 years
|
0.00%
0/12 • 2 years
|
|
Investigations
White Blood Cell Decreased
|
0.00%
0/12 • 2 years
|
0.00%
0/3 • 2 years
|
8.3%
1/12 • Number of events 1 • 2 years
|
|
Cardiac disorders
Multifocal Atrial Tachycardia
|
8.3%
1/12 • Number of events 1 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/12 • 2 years
|
|
General disorders
Irritability
|
8.3%
1/12 • Number of events 1 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/12 • 2 years
|
|
General disorders
Pain
|
0.00%
0/12 • 2 years
|
33.3%
1/3 • Number of events 1 • 2 years
|
0.00%
0/12 • 2 years
|
|
Hepatobiliary disorders
Mild Transaminitis
|
0.00%
0/12 • 2 years
|
33.3%
1/3 • Number of events 2 • 2 years
|
0.00%
0/12 • 2 years
|
|
Infections and infestations
Vaginal Candidiasis
|
0.00%
0/12 • 2 years
|
33.3%
1/3 • Number of events 1 • 2 years
|
0.00%
0/12 • 2 years
|
|
Infections and infestations
Oral Candidiasis
|
0.00%
0/12 • 2 years
|
33.3%
1/3 • Number of events 1 • 2 years
|
8.3%
1/12 • Number of events 1 • 2 years
|
|
Infections and infestations
Upper Respiratory infection
|
16.7%
2/12 • Number of events 2 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/12 • 2 years
|
|
Investigations
Neutrophil Count Decreased
|
16.7%
2/12 • Number of events 4 • 2 years
|
33.3%
1/3 • Number of events 1 • 2 years
|
0.00%
0/12 • 2 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
8.3%
1/12 • Number of events 1 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/12 • 2 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
8.3%
1/12 • Number of events 1 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/12 • 2 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/12 • 2 years
|
33.3%
1/3 • Number of events 3 • 2 years
|
0.00%
0/12 • 2 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
8.3%
1/12 • Number of events 1 • 2 years
|
33.3%
1/3 • Number of events 3 • 2 years
|
0.00%
0/12 • 2 years
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
8.3%
1/12 • Number of events 1 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/12 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
0.00%
0/12 • 2 years
|
33.3%
1/3 • Number of events 1 • 2 years
|
0.00%
0/12 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/12 • 2 years
|
33.3%
1/3 • Number of events 1 • 2 years
|
0.00%
0/12 • 2 years
|
|
Nervous system disorders
Altered Mental Status
|
8.3%
1/12 • Number of events 1 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/12 • 2 years
|
|
Nervous system disorders
Tremor
|
8.3%
1/12 • Number of events 1 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/12 • 2 years
|
|
Psychiatric disorders
Insomnia
|
8.3%
1/12 • Number of events 1 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/12 • 2 years
|
|
Reproductive system and breast disorders
Irregular Menstruation
|
8.3%
1/12 • Number of events 1 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/12 • 2 years
|
|
Reproductive system and breast disorders
Pelvic Pain
|
8.3%
1/12 • Number of events 2 • 2 years
|
33.3%
1/3 • Number of events 1 • 2 years
|
0.00%
0/12 • 2 years
|
|
Reproductive system and breast disorders
Vaginal pain
|
0.00%
0/12 • 2 years
|
33.3%
1/3 • Number of events 2 • 2 years
|
0.00%
0/12 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/12 • 2 years
|
33.3%
1/3 • Number of events 1 • 2 years
|
0.00%
0/12 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/12 • 2 years
|
33.3%
1/3 • Number of events 1 • 2 years
|
0.00%
0/12 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Edema
|
0.00%
0/12 • 2 years
|
33.3%
1/3 • Number of events 1 • 2 years
|
0.00%
0/12 • 2 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.3%
1/12 • Number of events 1 • 2 years
|
33.3%
1/3 • Number of events 1 • 2 years
|
0.00%
0/12 • 2 years
|
|
Skin and subcutaneous tissue disorders
Rash Acneiform
|
8.3%
1/12 • Number of events 1 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/12 • 2 years
|
|
Skin and subcutaneous tissue disorders
Rash manuco-papular
|
8.3%
1/12 • Number of events 1 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/12 • 2 years
|
|
Skin and subcutaneous tissue disorders
Scalp Pain
|
0.00%
0/12 • 2 years
|
33.3%
1/3 • Number of events 1 • 2 years
|
0.00%
0/12 • 2 years
|
|
Vascular disorders
Hypertension
|
8.3%
1/12 • Number of events 1 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/12 • 2 years
|
|
Vascular disorders
Hypotension
|
8.3%
1/12 • Number of events 1 • 2 years
|
33.3%
1/3 • Number of events 1 • 2 years
|
0.00%
0/12 • 2 years
|
|
Hepatobiliary disorders
Shock Liver
|
0.00%
0/12 • 2 years
|
33.3%
1/3 • Number of events 1 • 2 years
|
0.00%
0/12 • 2 years
|
Additional Information
Joel W. Neal, MD PhD, Assistant Professor of Medicine (Oncology)
Stanford University
Phone: (650) 498-4696
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place