Trial Outcomes & Findings for Study of Carfilzomib With Irinotecan in Irinotecan-Sensitive Malignancies and Small Cell Lung Cancer Patients (NCT NCT01941316)
NCT ID: NCT01941316
Last Updated: 2024-05-09
Results Overview
Maximum tolerated dose of Carfilzomib in combination with Irinotecan in subjects with relapsed small and non-small cell lung cancer or other irinotecan-sensitive cancers.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
78 participants
Primary outcome timeframe
28 Days
Results posted on
2024-05-09
Participant Flow
Participant milestones
| Measure |
Phase Ib Cohort 1: 20/27 mg/m^2 Carfilzomib, 125 mg/m2 Irinotecan
Cohort 1 of Phase Ib run-in to determine maximum tolerated dose (MTD) of Carfilzomib (Day 1,2,8,9, 15, and 16) in combination with Irinotecan (Days 1, 8, 15) in subjects with relapsed small and non-small cell lung cancer or other irinotecan-sensitive cancers.
Cohort 1 used a starting dose of 20/27 mg/m\^2 of carfilzomib in combination with 125 mg/m\^2 of irinotecan.
|
Phase Ib Cohort 2: 20/36 mg/m^2 Carfilzomib, 125 mg/m2 Irinotecan
Cohort 2 of Phase Ib run-in to determine maximum tolerated dose (MTD) of Carfilzomib (Day 1,2,8,9, 15, and 16) in combination with Irinotecan (Days 1, 8, 15) in subjects with relapsed small and non-small cell lung cancer or other irinotecan-sensitive cancers.
Cohort 2 used a starting dose of 20/36 mg/m\^2 of carfilzomib in combination with 125 mg/m\^2 of irinotecan.
|
Phase Ib Cohort 3: 20/45 mg/m^2 Carfilzomib, 125 mg/m2 Irinotecan
Cohort 3 of Phase Ib run-in to determine maximum tolerated dose (MTD) of Carfilzomib (Day 1,2,8,9, 15, and 16) in combination with Irinotecan (Days 1, 8, 15) in subjects with relapsed small and non-small cell lung cancer or other irinotecan-sensitive cancers.
Cohort 3 used a starting dose of 20/45 mg/m\^2 of carfilzomib in combination with 125 mg/m\^2 of irinotecan.
|
Phase II: Trial of Carfilzomib With Irinotecan, SCLC Subjects
Phase II: Stratified, single arm trial, starting dose of 20/36 mg/m2 of carfilzomib and 125 mg/m2 of irinotecan, small cell lung cancer patients who relapsed on a prior platinum regimen.
Stratification:
Platinum sensitive disease: initial response to platinum-based chemotherapy with progression \> 90 days after last treatment.
Platinum refractory disease: No response to platinum-based chemotherapy or progression within 90 days of completing platinum-based therapy. Subjects who progressed within 1 month of completed platinum-based chemotherapy were excluded.
Carfilzomib: 20/36 mg/m2 stepped up dosing, IV infusion (30 min), days 1, 2, 8, 9, 15 and 16 of each 28 day cycle. # cycles: 6, until progression, or unacceptable toxicity, or treatment delay for any reason greater than 3 weeks.
Irinotecan: 125 mg/m2, IV infusion (90 min), days 1, 8, 15 of each 28 day cycle. # cycles: 6, until progression, or unacceptable toxicity, or treatment delay for any reason greater than 3 weeks.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
9
|
3
|
62
|
|
Overall Study
COMPLETED
|
1
|
0
|
0
|
7
|
|
Overall Study
NOT COMPLETED
|
3
|
9
|
3
|
55
|
Reasons for withdrawal
| Measure |
Phase Ib Cohort 1: 20/27 mg/m^2 Carfilzomib, 125 mg/m2 Irinotecan
Cohort 1 of Phase Ib run-in to determine maximum tolerated dose (MTD) of Carfilzomib (Day 1,2,8,9, 15, and 16) in combination with Irinotecan (Days 1, 8, 15) in subjects with relapsed small and non-small cell lung cancer or other irinotecan-sensitive cancers.
Cohort 1 used a starting dose of 20/27 mg/m\^2 of carfilzomib in combination with 125 mg/m\^2 of irinotecan.
|
Phase Ib Cohort 2: 20/36 mg/m^2 Carfilzomib, 125 mg/m2 Irinotecan
Cohort 2 of Phase Ib run-in to determine maximum tolerated dose (MTD) of Carfilzomib (Day 1,2,8,9, 15, and 16) in combination with Irinotecan (Days 1, 8, 15) in subjects with relapsed small and non-small cell lung cancer or other irinotecan-sensitive cancers.
Cohort 2 used a starting dose of 20/36 mg/m\^2 of carfilzomib in combination with 125 mg/m\^2 of irinotecan.
|
Phase Ib Cohort 3: 20/45 mg/m^2 Carfilzomib, 125 mg/m2 Irinotecan
Cohort 3 of Phase Ib run-in to determine maximum tolerated dose (MTD) of Carfilzomib (Day 1,2,8,9, 15, and 16) in combination with Irinotecan (Days 1, 8, 15) in subjects with relapsed small and non-small cell lung cancer or other irinotecan-sensitive cancers.
Cohort 3 used a starting dose of 20/45 mg/m\^2 of carfilzomib in combination with 125 mg/m\^2 of irinotecan.
|
Phase II: Trial of Carfilzomib With Irinotecan, SCLC Subjects
Phase II: Stratified, single arm trial, starting dose of 20/36 mg/m2 of carfilzomib and 125 mg/m2 of irinotecan, small cell lung cancer patients who relapsed on a prior platinum regimen.
Stratification:
Platinum sensitive disease: initial response to platinum-based chemotherapy with progression \> 90 days after last treatment.
Platinum refractory disease: No response to platinum-based chemotherapy or progression within 90 days of completing platinum-based therapy. Subjects who progressed within 1 month of completed platinum-based chemotherapy were excluded.
Carfilzomib: 20/36 mg/m2 stepped up dosing, IV infusion (30 min), days 1, 2, 8, 9, 15 and 16 of each 28 day cycle. # cycles: 6, until progression, or unacceptable toxicity, or treatment delay for any reason greater than 3 weeks.
Irinotecan: 125 mg/m2, IV infusion (90 min), days 1, 8, 15 of each 28 day cycle. # cycles: 6, until progression, or unacceptable toxicity, or treatment delay for any reason greater than 3 weeks.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
7
|
|
Overall Study
Progressive Disease
|
3
|
6
|
2
|
29
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
1
|
8
|
|
Overall Study
Death
|
0
|
0
|
0
|
3
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
3
|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
3
|
|
Overall Study
Intercurrent illness
|
0
|
0
|
0
|
1
|
|
Overall Study
Other, not specified
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Study of Carfilzomib With Irinotecan in Irinotecan-Sensitive Malignancies and Small Cell Lung Cancer Patients
Baseline characteristics by cohort
| Measure |
Phase Ib Cohort 1: 20/27 mg/m^2 Carfilzomib, 125 mg/m^2 Irinotecan
n=4 Participants
Cohort 1 of Phase Ib run-in to determine maximum tolerated dose (MTD) of Carfilzomib (Day 1,2,8,9, 15, and 16) in combination with Irinotecan (Days 1, 8, 15) in subjects with relapsed small and non-small cell lung cancer or other irinotecan-sensitive cancers.
Cohort 1 used a starting dose of 20/27 mg/m\^2 of carfilzomib in combination with 125 mg/m\^2 of irinotecan.
|
Phase Ib Cohort 2: 20/36 mg/m^2 Carfilzomib, 125 mg/m^2 Irinotecan
n=9 Participants
Cohort 2 of Phase Ib run-in to determine maximum tolerated dose (MTD) of Carfilzomib (Day 1,2,8,9, 15, and 16) in combination with Irinotecan (Days 1, 8, 15) in subjects with relapsed small and non-small cell lung cancer or other irinotecan-sensitive cancers.
Cohort 2 used a starting dose of 20/36 mg/m\^2 of carfilzomib in combination with 125 mg/m\^2 of irinotecan.
|
Phase Ib Cohort 3: 20/45 mg/m^2 Carfilzomib, 125 mg/m^2 Irinotecan
n=3 Participants
Cohort 3 of Phase Ib run-in to determine maximum tolerated dose (MTD) of Carfilzomib (Day 1,2,8,9, 15, and 16) in combination with Irinotecan (Days 1, 8, 15) in subjects with relapsed small and non-small cell lung cancer or other irinotecan-sensitive cancers.
Cohort 3 used a starting dose of 20/45 mg/m\^2 of carfilzomib in combination with 125 mg/m\^2 of irinotecan.
|
Phase II
n=62 Participants
Phase II: Stratified, single arm trial using a starting dose of 20/36 mg/m\^2 of carfilzomib and 125 mg/m\^2 of irinotecan, in small cell lung cancer patients who have relapsed on a prior platinum regimen.
Stratification for phase II component:
1. Platinum sensitive disease: initial response to platinum-based chemotherapy with progression \> 90 days after last treatment.
2. Platinum refractory disease: No response to platinum-based chemotherapy or progression within 90 days of completing platinum-based therapy.
Subjects that progressed during or within one month of completion of platinum-based chemotherapy will be excluded.
|
Total
n=78 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
34 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
44 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
42 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
36 Participants
n=21 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
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 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
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
59 Participants
n=4 Participants
|
74 Participants
n=21 Participants
|
|
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
|
0 Participants
n=21 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
|
0 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 28 DaysPopulation: Subjects with relapsed small and non-small cell lung cancer or other irinotecan-sensitive cancers. Subjects were given Carfilzomib (Day 1,2,8,9, 15, and 16) in combination with Irinotecan (Days 1, 8, 15) in a standard 3+3 dose-finding design.
Maximum tolerated dose of Carfilzomib in combination with Irinotecan in subjects with relapsed small and non-small cell lung cancer or other irinotecan-sensitive cancers.
Outcome measures
| Measure |
Phase 1b: All Patients Enrolled for MTD Determination of Carfilzomib With Irinotecan
n=16 Participants
16 total subjects with relapsed small and non-small cell lung cancer or other irinotecan-sensitive cancers. Subjects were given Carfilzomib (Day 1,2,8,9, 15, and 16) in combination with Irinotecan (Days 1, 8, 15) in a standard 3+3 dose-finding design.
|
Platinum Refractory Disease
No response to platinum-based chemotherapy or progression within 90 days of completing platinum-based therapy. Subjects that progressed during or within one month of completion of platinum-based chemotherapy will be excluded.
|
Phase Ib Cohort 3: 20/45 mg/m^2 Carfilzomib, 125 mg/m^2 Irinotecan
Cohort 3 of Phase Ib run-in to determine maximum tolerated dose (MTD) of Carfilzomib (Day 1,2,8,9, 15, and 16) in combination with Irinotecan (Days 1, 8, 15) in subjects with relapsed small and non-small cell lung cancer or other irinotecan-sensitive cancers.
Cohort 3 used a starting dose of 20/45 mg/m\^2 of carfilzomib in combination with 125 mg/m\^2 of irinotecan.
|
Phase II: Platinum Sensitive Disease
Initial response to platinum-based chemotherapy with progression \> 90 days after last treatment.
|
Phase II: Platinum Refractory Disease
No response to platinum-based chemotherapy or progression within 90 days of completing platinum-based therapy. Subjects who progressed within 1 month of completed platinum-based chemotherapy were excluded.
|
|---|---|---|---|---|---|
|
Phase Ib: Maximum Tolerated Dose
MTD for Cycle 1 Day 1 and Day 2 doses
|
20 mg/m^2 Carfilzomib
|
—
|
—
|
—
|
—
|
|
Phase Ib: Maximum Tolerated Dose
MTD for all doses after Cycle 1 Days 1 and 2
|
36 mg/m^2 Carfilzomib
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: up to 6 MonthsPopulation: A total of 62 eligible relapsed small cell lung cancer patients treated with Carfilzomib in combination with Irinotecan.
Estimate of 6-month overall survival (OS) rate of relapsed small cell lung cancer patients treated with Carfilzomib in combination with Irinotecan. The survival function was estimated using the Kaplan-Meier method, with overall survival defined as time from enrollment until death. Patients with no date of death were censored at the time of last contact.
Outcome measures
| Measure |
Phase 1b: All Patients Enrolled for MTD Determination of Carfilzomib With Irinotecan
n=37 Participants
16 total subjects with relapsed small and non-small cell lung cancer or other irinotecan-sensitive cancers. Subjects were given Carfilzomib (Day 1,2,8,9, 15, and 16) in combination with Irinotecan (Days 1, 8, 15) in a standard 3+3 dose-finding design.
|
Platinum Refractory Disease
n=25 Participants
No response to platinum-based chemotherapy or progression within 90 days of completing platinum-based therapy. Subjects that progressed during or within one month of completion of platinum-based chemotherapy will be excluded.
|
Phase Ib Cohort 3: 20/45 mg/m^2 Carfilzomib, 125 mg/m^2 Irinotecan
Cohort 3 of Phase Ib run-in to determine maximum tolerated dose (MTD) of Carfilzomib (Day 1,2,8,9, 15, and 16) in combination with Irinotecan (Days 1, 8, 15) in subjects with relapsed small and non-small cell lung cancer or other irinotecan-sensitive cancers.
Cohort 3 used a starting dose of 20/45 mg/m\^2 of carfilzomib in combination with 125 mg/m\^2 of irinotecan.
|
Phase II: Platinum Sensitive Disease
Initial response to platinum-based chemotherapy with progression \> 90 days after last treatment.
|
Phase II: Platinum Refractory Disease
No response to platinum-based chemotherapy or progression within 90 days of completing platinum-based therapy. Subjects who progressed within 1 month of completed platinum-based chemotherapy were excluded.
|
|---|---|---|---|---|---|
|
Phase II: Overall Survival Rate at 6 Months
|
0.59 Proportion with 6-month OS by KM
Interval 0.41 to 0.73
|
0.54 Proportion with 6-month OS by KM
Interval 0.33 to 0.71
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From enrollment until the earliest out of date of discontinuation from study or deathPopulation: Relapsed small cell lung cancer patients treated with Carfilzomib in combination with Irinotecan.
Rate of overall response of relapsed small cell lung cancer patients treated with Carfilzomib in combination with Irinotecan. Responses were evaluated by the criteria defined in RECIST v1.1. Patients were categorized at each response assessment as having one of the following: complete response (CR) partial response (PR) stable disease (SD) progressive disease (PD) not assessable (NA) Overall response rate is defined as the proportion of patients achieving a best response of PR or better while on study; in other words, the proportion of patients achieving a CR or PR while on study.
Outcome measures
| Measure |
Phase 1b: All Patients Enrolled for MTD Determination of Carfilzomib With Irinotecan
n=4 Participants
16 total subjects with relapsed small and non-small cell lung cancer or other irinotecan-sensitive cancers. Subjects were given Carfilzomib (Day 1,2,8,9, 15, and 16) in combination with Irinotecan (Days 1, 8, 15) in a standard 3+3 dose-finding design.
|
Platinum Refractory Disease
n=9 Participants
No response to platinum-based chemotherapy or progression within 90 days of completing platinum-based therapy. Subjects that progressed during or within one month of completion of platinum-based chemotherapy will be excluded.
|
Phase Ib Cohort 3: 20/45 mg/m^2 Carfilzomib, 125 mg/m^2 Irinotecan
n=3 Participants
Cohort 3 of Phase Ib run-in to determine maximum tolerated dose (MTD) of Carfilzomib (Day 1,2,8,9, 15, and 16) in combination with Irinotecan (Days 1, 8, 15) in subjects with relapsed small and non-small cell lung cancer or other irinotecan-sensitive cancers.
Cohort 3 used a starting dose of 20/45 mg/m\^2 of carfilzomib in combination with 125 mg/m\^2 of irinotecan.
|
Phase II: Platinum Sensitive Disease
n=37 Participants
Initial response to platinum-based chemotherapy with progression \> 90 days after last treatment.
|
Phase II: Platinum Refractory Disease
n=25 Participants
No response to platinum-based chemotherapy or progression within 90 days of completing platinum-based therapy. Subjects who progressed within 1 month of completed platinum-based chemotherapy were excluded.
|
|---|---|---|---|---|---|
|
Overall Response Rate
|
0.250 proportion of patients
|
0.111 proportion of patients
|
0.333 proportion of patients
|
0.216 proportion of patients
|
0.125 proportion of patients
|
SECONDARY outcome
Timeframe: up to 6 monthsPopulation: A total of 62 eligible relapsed small cell lung cancer patients treated with Carfilzomib in combination with Irinotecan.
Estimate of 6-month progression-free survival (PFS) rate of relapsed small cell lung cancer patients treated with Carfilzomib in combination with Irinotecan. The survival function was estimated using the Kaplan-Meier method, with progression-free survival defined as time from enrollment until disease progression or death. Patients with no date of death and no date of disease progression were censored at the time of last contact.
Outcome measures
| Measure |
Phase 1b: All Patients Enrolled for MTD Determination of Carfilzomib With Irinotecan
n=37 Participants
16 total subjects with relapsed small and non-small cell lung cancer or other irinotecan-sensitive cancers. Subjects were given Carfilzomib (Day 1,2,8,9, 15, and 16) in combination with Irinotecan (Days 1, 8, 15) in a standard 3+3 dose-finding design.
|
Platinum Refractory Disease
n=25 Participants
No response to platinum-based chemotherapy or progression within 90 days of completing platinum-based therapy. Subjects that progressed during or within one month of completion of platinum-based chemotherapy will be excluded.
|
Phase Ib Cohort 3: 20/45 mg/m^2 Carfilzomib, 125 mg/m^2 Irinotecan
Cohort 3 of Phase Ib run-in to determine maximum tolerated dose (MTD) of Carfilzomib (Day 1,2,8,9, 15, and 16) in combination with Irinotecan (Days 1, 8, 15) in subjects with relapsed small and non-small cell lung cancer or other irinotecan-sensitive cancers.
Cohort 3 used a starting dose of 20/45 mg/m\^2 of carfilzomib in combination with 125 mg/m\^2 of irinotecan.
|
Phase II: Platinum Sensitive Disease
Initial response to platinum-based chemotherapy with progression \> 90 days after last treatment.
|
Phase II: Platinum Refractory Disease
No response to platinum-based chemotherapy or progression within 90 days of completing platinum-based therapy. Subjects who progressed within 1 month of completed platinum-based chemotherapy were excluded.
|
|---|---|---|---|---|---|
|
Phase II: Progression-Free Survival Rate at 6 Months
|
0.32 Proportion with 6-month PFS by KM
Interval 0.18 to 0.47
|
0.12 Proportion with 6-month PFS by KM
Interval 0.03 to 0.28
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: up to 6 monthsPopulation: Subjects with relapsed small and non-small cell lung cancer or other irinotecan-sensitive cancers. Subjects were given Carfilzomib (Day 1,2,8,9, 15, and 16) in combination with Irinotecan (Days 1, 8, 15) in a standard 3+3 dose-finding design.
Number of Dose Limiting Toxicity (DLT) adverse events related to Carfilzomib in combination with Irinotecan administration. Subjects were evaluated for toxicity according to the Common Terminology Criteria for Adverse Events (CTCAE) of version 4.0. A DLT is defined as any of the treatment emergent toxicities with attribution to one or more of the study drugs that occur during Cycle 1. Non-hematologic: * ≥ Grade 2 neuropathy with pain * ≥ Any Grade 3 or 4 toxicity (excluding nausea, vomiting, diarrhea or grade 3 fatigue) * ≥ Grade 3 nausea, vomiting, or diarrhea lasting \> 7 days despite maximal antiemetic/antidiarrheal therapy * ≥ Grade 4 fatigue lasting for ≥ 7 days Hematologic: Grade 4 neutropenia lasting for ≥ 7 days, Febrile neutropenia, Grade 4 thrombocytopenia lasting ≥ 7 days despite dose delay, Grade 3-4 thrombocytopenia associated with bleeding
Outcome measures
| Measure |
Phase 1b: All Patients Enrolled for MTD Determination of Carfilzomib With Irinotecan
n=4 Participants
16 total subjects with relapsed small and non-small cell lung cancer or other irinotecan-sensitive cancers. Subjects were given Carfilzomib (Day 1,2,8,9, 15, and 16) in combination with Irinotecan (Days 1, 8, 15) in a standard 3+3 dose-finding design.
|
Platinum Refractory Disease
n=9 Participants
No response to platinum-based chemotherapy or progression within 90 days of completing platinum-based therapy. Subjects that progressed during or within one month of completion of platinum-based chemotherapy will be excluded.
|
Phase Ib Cohort 3: 20/45 mg/m^2 Carfilzomib, 125 mg/m^2 Irinotecan
n=3 Participants
Cohort 3 of Phase Ib run-in to determine maximum tolerated dose (MTD) of Carfilzomib (Day 1,2,8,9, 15, and 16) in combination with Irinotecan (Days 1, 8, 15) in subjects with relapsed small and non-small cell lung cancer or other irinotecan-sensitive cancers.
Cohort 3 used a starting dose of 20/45 mg/m\^2 of carfilzomib in combination with 125 mg/m\^2 of irinotecan.
|
Phase II: Platinum Sensitive Disease
Initial response to platinum-based chemotherapy with progression \> 90 days after last treatment.
|
Phase II: Platinum Refractory Disease
No response to platinum-based chemotherapy or progression within 90 days of completing platinum-based therapy. Subjects who progressed within 1 month of completed platinum-based chemotherapy were excluded.
|
|---|---|---|---|---|---|
|
Phase Ib: Dose Limiting Toxicities
Dehydration
|
0 Dose Limiting Toxicities
|
1 Dose Limiting Toxicities
|
1 Dose Limiting Toxicities
|
—
|
—
|
|
Phase Ib: Dose Limiting Toxicities
Diarrhea
|
0 Dose Limiting Toxicities
|
0 Dose Limiting Toxicities
|
1 Dose Limiting Toxicities
|
—
|
—
|
Adverse Events
Phase Ib Cohort 1: 20/27 mg/m^2 Carfilzomib, 125 mg/m^2 Irinotecan
Serious events: 2 serious events
Other events: 4 other events
Deaths: 2 deaths
Phase Ib Cohort 2: 20/36 mg/m^2 Carfilzomib, 125 mg/m^2 Irinotecan
Serious events: 3 serious events
Other events: 9 other events
Deaths: 5 deaths
Phase Ib Cohort 3: 20/45 mg/m^2 Carfilzomib, 125 mg/m^2 Irinotecan
Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths
Phase II
Serious events: 31 serious events
Other events: 60 other events
Deaths: 51 deaths
Serious adverse events
| Measure |
Phase Ib Cohort 1: 20/27 mg/m^2 Carfilzomib, 125 mg/m^2 Irinotecan
n=4 participants at risk
Cohort 1 of Phase Ib run-in to determine maximum tolerated dose (MTD) of Carfilzomib (Day 1,2,8,9, 15, and 16) in combination with Irinotecan (Days 1, 8, 15) in subjects with relapsed small and non-small cell lung cancer or other irinotecan-sensitive cancers.
Cohort 1 used a starting dose of 20/27 mg/m\^2 of carfilzomib in combination with 125 mg/m\^2 of irinotecan.
|
Phase Ib Cohort 2: 20/36 mg/m^2 Carfilzomib, 125 mg/m^2 Irinotecan
n=9 participants at risk
Cohort 2 of Phase Ib run-in to determine maximum tolerated dose (MTD) of Carfilzomib (Day 1,2,8,9, 15, and 16) in combination with Irinotecan (Days 1, 8, 15) in subjects with relapsed small and non-small cell lung cancer or other irinotecan-sensitive cancers.
Cohort 2 used a starting dose of 20/36 mg/m\^2 of carfilzomib in combination with 125 mg/m\^2 of irinotecan.
|
Phase Ib Cohort 3: 20/45 mg/m^2 Carfilzomib, 125 mg/m^2 Irinotecan
n=3 participants at risk
Cohort 3 of Phase Ib run-in to determine maximum tolerated dose (MTD) of Carfilzomib (Day 1,2,8,9, 15, and 16) in combination with Irinotecan (Days 1, 8, 15) in subjects with relapsed small and non-small cell lung cancer or other irinotecan-sensitive cancers.
Cohort 3 used a starting dose of 20/45 mg/m\^2 of carfilzomib in combination with 125 mg/m\^2 of irinotecan.
|
Phase II
n=62 participants at risk
Phase II: Stratified, single arm trial using a starting dose of 20/36 mg/m\^2 of carfilzomib and 125 mg/m\^2 of irinotecan, in small cell lung cancer patients who have relapsed on a prior platinum regimen.
Stratification for phase II component:
1. Platinum sensitive disease: initial response to platinum-based chemotherapy with progression \> 90 days after last treatment.
2. Platinum refractory disease: No response to platinum-based chemotherapy or progression within 90 days of completing platinum-based therapy. Subjects that progressed during or within one month of completion of platinum-based chemotherapy will be excluded.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
33.3%
1/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
1.6%
1/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
11.1%
1/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
21.0%
13/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
|
Gastrointestinal disorders
Dysphagia
|
25.0%
1/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
|
General disorders
Fatigue
|
0.00%
0/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
11.1%
1/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
1.6%
1/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
|
Hepatobiliary disorders
Hepatobiliary disorders- Other
|
0.00%
0/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
11.1%
1/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
33.3%
1/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
16.1%
10/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
11.1%
1/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
33.3%
1/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
1.6%
1/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms, all
|
25.0%
1/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
|
Nervous system disorders
Peripheral motor neuropathy
|
25.0%
1/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
|
Nervous system disorders
RLNP
|
25.0%
1/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
|
Nervous system disorders
Transient ischemic attacks
|
0.00%
0/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
33.3%
1/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
|
Psychiatric disorders
Confusion
|
0.00%
0/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
33.3%
1/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
33.3%
1/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
33.3%
1/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
33.3%
1/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
1.6%
1/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
1.6%
1/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
4.8%
3/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
|
Gastrointestinal disorders
Lower GI hemorrhage
|
0.00%
0/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
1.6%
1/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
|
Gastrointestinal disorders
Proctocolitis
|
0.00%
0/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
1.6%
1/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
|
General disorders
Sudden death NOS
|
0.00%
0/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
1.6%
1/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
|
Infections and infestations
Lung infection
|
0.00%
0/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
4.8%
3/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
|
Infections and infestations
Sepsis
|
0.00%
0/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
4.8%
3/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
1.6%
1/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
1.6%
1/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
4.8%
3/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
4.8%
3/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
|
Respiratory, thoracic and mediastinal disorders
ARDS
|
0.00%
0/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
1.6%
1/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
1.6%
1/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
1.6%
1/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
1.6%
1/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
3.2%
2/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
3.2%
2/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
1.6%
1/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
|
Gastrointestinal disorders
Retroperitoneal hemorrhage
|
0.00%
0/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
1.6%
1/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
3.2%
2/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
1.6%
1/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
3.2%
2/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
4.8%
3/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
1.6%
1/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
|
Investigations
Platelet count decreased
|
0.00%
0/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
1.6%
1/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
|
Investigations
White blood cell decreased
|
0.00%
0/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
1.6%
1/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
1.6%
1/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
|
Nervous system disorders
Somnolence
|
0.00%
0/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
1.6%
1/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
1.6%
1/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
|
Vascular disorders
Hematoma
|
0.00%
0/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
1.6%
1/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
Other adverse events
| Measure |
Phase Ib Cohort 1: 20/27 mg/m^2 Carfilzomib, 125 mg/m^2 Irinotecan
n=4 participants at risk
Cohort 1 of Phase Ib run-in to determine maximum tolerated dose (MTD) of Carfilzomib (Day 1,2,8,9, 15, and 16) in combination with Irinotecan (Days 1, 8, 15) in subjects with relapsed small and non-small cell lung cancer or other irinotecan-sensitive cancers.
Cohort 1 used a starting dose of 20/27 mg/m\^2 of carfilzomib in combination with 125 mg/m\^2 of irinotecan.
|
Phase Ib Cohort 2: 20/36 mg/m^2 Carfilzomib, 125 mg/m^2 Irinotecan
n=9 participants at risk
Cohort 2 of Phase Ib run-in to determine maximum tolerated dose (MTD) of Carfilzomib (Day 1,2,8,9, 15, and 16) in combination with Irinotecan (Days 1, 8, 15) in subjects with relapsed small and non-small cell lung cancer or other irinotecan-sensitive cancers.
Cohort 2 used a starting dose of 20/36 mg/m\^2 of carfilzomib in combination with 125 mg/m\^2 of irinotecan.
|
Phase Ib Cohort 3: 20/45 mg/m^2 Carfilzomib, 125 mg/m^2 Irinotecan
n=3 participants at risk
Cohort 3 of Phase Ib run-in to determine maximum tolerated dose (MTD) of Carfilzomib (Day 1,2,8,9, 15, and 16) in combination with Irinotecan (Days 1, 8, 15) in subjects with relapsed small and non-small cell lung cancer or other irinotecan-sensitive cancers.
Cohort 3 used a starting dose of 20/45 mg/m\^2 of carfilzomib in combination with 125 mg/m\^2 of irinotecan.
|
Phase II
n=62 participants at risk
Phase II: Stratified, single arm trial using a starting dose of 20/36 mg/m\^2 of carfilzomib and 125 mg/m\^2 of irinotecan, in small cell lung cancer patients who have relapsed on a prior platinum regimen.
Stratification for phase II component:
1. Platinum sensitive disease: initial response to platinum-based chemotherapy with progression \> 90 days after last treatment.
2. Platinum refractory disease: No response to platinum-based chemotherapy or progression within 90 days of completing platinum-based therapy. Subjects that progressed during or within one month of completion of platinum-based chemotherapy will be excluded.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
25.0%
1/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
33.3%
1/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
38.7%
24/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
1.6%
1/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
|
Cardiac disorders
Cardiac disorder - Other
|
25.0%
1/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
|
Gastrointestinal disorders
Abdominal pain
|
25.0%
1/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
33.3%
3/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
33.3%
1/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
12.9%
8/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
3.2%
2/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
|
Gastrointestinal disorders
Constipation
|
25.0%
1/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
11.1%
1/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
9.7%
6/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
|
Gastrointestinal disorders
Diarrhea
|
50.0%
2/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
77.8%
7/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
66.7%
2/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
64.5%
40/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
11.1%
1/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
|
Gastrointestinal disorders
Esophagitis
|
25.0%
1/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
|
Gastrointestinal disorders
GERD
|
25.0%
1/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
|
Gastrointestinal disorders
Nausea
|
25.0%
1/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
55.6%
5/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
66.7%
2/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
43.5%
27/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
33.3%
3/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
9.7%
6/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
|
Gastrointestinal disorders
GI disorders - Other
|
0.00%
0/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
22.2%
2/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
33.3%
1/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
|
General disorders
Chills
|
0.00%
0/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
11.1%
1/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
|
General disorders
Edema limbs
|
0.00%
0/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
11.1%
1/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
|
General disorders
Fatigue
|
50.0%
2/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
44.4%
4/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
100.0%
3/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
66.1%
41/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
|
General disorders
Infusion related reaction
|
25.0%
1/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
|
Infections and infestations
Lung infection
|
0.00%
0/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
3.2%
2/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
|
Infections and infestations
Mucosal infection
|
25.0%
1/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
|
Infections and infestations
Urinary tract infection
|
25.0%
1/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
11.1%
1/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
1.6%
1/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
11.1%
1/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
11.1%
1/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
33.3%
1/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
|
Investigations
ALT increased
|
25.0%
1/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
8.1%
5/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
|
Investigations
AST increased
|
25.0%
1/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
33.3%
1/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
11.1%
1/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
|
Investigations
Creatinine increased
|
0.00%
0/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
11.1%
1/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
33.3%
1/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
1.6%
1/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
|
Investigations
Lymphocyte count decreased
|
25.0%
1/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
24.2%
15/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
|
Investigations
Neutrophil count decreased
|
25.0%
1/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
11.1%
1/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
33.3%
1/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
30.6%
19/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
|
Investigations
Platelet count decreased
|
25.0%
1/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
11.1%
1/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
66.7%
2/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
29.0%
18/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
|
Investigations
Weight loss
|
0.00%
0/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
33.3%
1/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
|
Investigations
White blood cell decreased
|
25.0%
1/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
11.1%
1/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
33.3%
1/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
27.4%
17/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
|
Investigations
Investigations - Other
|
0.00%
0/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
33.3%
1/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
1.6%
1/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
|
Metabolism and nutrition disorders
Anorexia
|
25.0%
1/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
33.3%
3/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
37.1%
23/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
33.3%
3/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
33.3%
1/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
3.2%
2/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
25.0%
1/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
25.0%
1/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
3.2%
2/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
25.0%
1/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
33.3%
1/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
8.1%
5/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
33.3%
1/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
3.2%
2/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
11.1%
1/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
33.3%
1/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
19.4%
12/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
33.3%
1/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
25.0%
1/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
11.1%
1/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
33.3%
1/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
6.5%
4/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
25.0%
1/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
11.1%
1/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
25.0%
1/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
|
Nervous system disorders
Dizziness
|
0.00%
0/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
11.1%
1/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
11.1%
1/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
|
Nervous system disorders
Sinus pain
|
0.00%
0/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
11.1%
1/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
|
Nervous system disorders
Syncope
|
0.00%
0/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
1.6%
1/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
|
Nervous system disorders
Tremor
|
0.00%
0/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
11.1%
1/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
|
Psychiatric disorders
Agitation
|
0.00%
0/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
1.6%
1/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
11.1%
1/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
|
Psychiatric disorders
Confusion
|
0.00%
0/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
11.1%
1/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
33.3%
1/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
22.2%
2/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
33.3%
1/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
9.7%
6/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
11.1%
1/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
|
Renal and urinary disorders
Urinary incontinence
|
25.0%
1/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
11.1%
1/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
|
Renal and urinary disorders
Renal/urinary disorders - Other
|
0.00%
0/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
11.1%
1/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
1/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
11.1%
1/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
25.0%
1/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
11.1%
1/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
11.3%
7/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
25.0%
1/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
3.2%
2/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
11.1%
1/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
33.3%
1/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
33.3%
1/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
11.1%
1/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
25.0%
1/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
|
Skin and subcutaneous tissue disorders
Skin/subq tissue ds - Other
|
0.00%
0/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
11.1%
1/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
|
Vascular disorders
Hot flashes
|
25.0%
1/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
|
Vascular disorders
Hypertension
|
0.00%
0/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
6.5%
4/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
|
Vascular disorders
Hypotension
|
0.00%
0/4 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
0.00%
0/9 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
33.3%
1/3 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
6.5%
4/62 • From enrollment until the earliest out of date of study completion, discontinuation from study, or death, an average of 3 months
|
Additional Information
Director of Quality and Regulatory Compliance
Cancer Research and Biostatistics
Phone: 206-839-1782
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place