Trial Outcomes & Findings for Pegylated Irinotecan NKTR 102 in Treating Patients With Relapsed Small Cell Lung Cancer (NCT NCT01876446)
NCT ID: NCT01876446
Last Updated: 2020-03-17
Results Overview
The distribution of time to disease progression will be estimated in each group using the method of Kaplan-Meier at 18 weeks.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
38 participants
Primary outcome timeframe
Time from registration to the date of first documented disease progression or death, assessed at 18 weeks
Results posted on
2020-03-17
Participant Flow
Participant milestones
| Measure |
A: Chemo Resistant
Group A: chemo resistant - those progressing on first-line therapy \< 3 months after completion of treatment.
Treatment (pegylated irinotecan NKTR 102) Patients receive pegylated irinotecan NKTR 102 IV over 90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Laboratory Biomarker Analysis: Correlative studies Pegylated Irinotecan: Given IV Pharmacological Study: Correlative studies
|
B: Chemo Sensitive
Group B: chemo sensitive - those progressing on first-line therapy ≥ 3 months after completion of treatment.
Treatment (pegylated irinotecan NKTR 102) Patients receive pegylated irinotecan NKTR 102 IV over 90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Laboratory Biomarker Analysis: Correlative studies
Pegylated Irinotecan: Given IV
Pharmacological Study: Correlative studies
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
18
|
|
Overall Study
COMPLETED
|
18
|
12
|
|
Overall Study
NOT COMPLETED
|
2
|
6
|
Reasons for withdrawal
| Measure |
A: Chemo Resistant
Group A: chemo resistant - those progressing on first-line therapy \< 3 months after completion of treatment.
Treatment (pegylated irinotecan NKTR 102) Patients receive pegylated irinotecan NKTR 102 IV over 90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Laboratory Biomarker Analysis: Correlative studies Pegylated Irinotecan: Given IV Pharmacological Study: Correlative studies
|
B: Chemo Sensitive
Group B: chemo sensitive - those progressing on first-line therapy ≥ 3 months after completion of treatment.
Treatment (pegylated irinotecan NKTR 102) Patients receive pegylated irinotecan NKTR 102 IV over 90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Laboratory Biomarker Analysis: Correlative studies
Pegylated Irinotecan: Given IV
Pharmacological Study: Correlative studies
|
|---|---|---|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
|
Overall Study
Physician Decision
|
1
|
3
|
Baseline Characteristics
Pegylated Irinotecan NKTR 102 in Treating Patients With Relapsed Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
A: Chemo Resistant
n=20 Participants
Group A: chemo resistant - those progressing on first-line therapy \< 3 months after completion of treatment.
Treatment (pegylated irinotecan NKTR 102) Patients receive pegylated irinotecan NKTR 102 IV over 90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Laboratory Biomarker Analysis: Correlative studies Pegylated Irinotecan: Given IV Pharmacological Study: Correlative studies
|
B: Chemo Sensitive
n=18 Participants
Group B: chemo sensitive - those progressing on first-line therapy ≥ 3 months after completion of treatment.
Treatment (pegylated irinotecan NKTR 102) Patients receive pegylated irinotecan NKTR 102 IV over 90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Laboratory Biomarker Analysis: Correlative studies
Pegylated Irinotecan: Given IV
Pharmacological Study: Correlative studies
|
Total
n=38 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
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Age, Continuous
|
60.5 years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
61.9 years
STANDARD_DEVIATION 7.9 • n=7 Participants
|
61.2 years
STANDARD_DEVIATION 8.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
ECOG performance status
Grade 0
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
ECOG performance status
Grade 1
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Time from registration to the date of first documented disease progression or death, assessed at 18 weeksPopulation: All treated and eligible patients
The distribution of time to disease progression will be estimated in each group using the method of Kaplan-Meier at 18 weeks.
Outcome measures
| Measure |
A: Chemo Resistant
n=20 Participants
Group A: chemo resistant - those progressing on first-line therapy \< 3 months after completion of treatment.
Treatment (pegylated irinotecan NKTR 102) Patients receive pegylated irinotecan NKTR 102 IV over 90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Laboratory Biomarker Analysis: Correlative studies Pegylated Irinotecan: Given IV Pharmacological Study: Correlative studies
|
B: Chemo Sensitive
n=18 Participants
Group B: chemo sensitive - those progressing on first-line therapy ≥ 3 months after completion of treatment.
Treatment (pegylated irinotecan NKTR 102) Patients receive pegylated irinotecan NKTR 102 IV over 90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Laboratory Biomarker Analysis: Correlative studies
Pegylated Irinotecan: Given IV
Pharmacological Study: Correlative studies
|
|---|---|---|
|
18 Week Progression-free Survival Rate
|
35 percentage of participants
Interval 16.0 to 55.0
|
72 percentage of participants
Interval 46.0 to 87.0
|
SECONDARY outcome
Timeframe: Up to 30 daysPopulation: All treated and eligible patients
Objective tumor response will be tabulated overall (and by dose level if appropriate). Responses will be summarized by simple descriptive summary statistics delineating complete and partial responses as well as stable and progressive disease in the cohorts (overall and by tumor group).
Outcome measures
| Measure |
A: Chemo Resistant
n=20 Participants
Group A: chemo resistant - those progressing on first-line therapy \< 3 months after completion of treatment.
Treatment (pegylated irinotecan NKTR 102) Patients receive pegylated irinotecan NKTR 102 IV over 90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Laboratory Biomarker Analysis: Correlative studies Pegylated Irinotecan: Given IV Pharmacological Study: Correlative studies
|
B: Chemo Sensitive
n=18 Participants
Group B: chemo sensitive - those progressing on first-line therapy ≥ 3 months after completion of treatment.
Treatment (pegylated irinotecan NKTR 102) Patients receive pegylated irinotecan NKTR 102 IV over 90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Laboratory Biomarker Analysis: Correlative studies
Pegylated Irinotecan: Given IV
Pharmacological Study: Correlative studies
|
|---|---|---|
|
Objective Tumor Response Measured With Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
|
20 percentage of participants
Interval 6.0 to 44.0
|
39 percentage of participants
Interval 17.0 to 64.0
|
SECONDARY outcome
Timeframe: Time from registration to death due to any cause, assessed up to 3 yearsPopulation: All participants that responded to treatment
The mean duration of response for those participants that responded to treatment by arm.
Outcome measures
| Measure |
A: Chemo Resistant
n=4 Participants
Group A: chemo resistant - those progressing on first-line therapy \< 3 months after completion of treatment.
Treatment (pegylated irinotecan NKTR 102) Patients receive pegylated irinotecan NKTR 102 IV over 90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Laboratory Biomarker Analysis: Correlative studies Pegylated Irinotecan: Given IV Pharmacological Study: Correlative studies
|
B: Chemo Sensitive
n=7 Participants
Group B: chemo sensitive - those progressing on first-line therapy ≥ 3 months after completion of treatment.
Treatment (pegylated irinotecan NKTR 102) Patients receive pegylated irinotecan NKTR 102 IV over 90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Laboratory Biomarker Analysis: Correlative studies
Pegylated Irinotecan: Given IV
Pharmacological Study: Correlative studies
|
|---|---|---|
|
Mean Duration of Response
|
5.4 months
Standard Deviation 3.8
|
7.0 months
Standard Deviation 6.8
|
SECONDARY outcome
Timeframe: Up to 30 daysPopulation: All treated and eligible patients
Count of participants by best response, defined as best objective status recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since treatment started), measured by RECIST 1.1 Tumor response is defined as a complete response (CR) or partial response (PR) by RECIST 1.1 criteria, which will be evaluated by CT scan every other cycle. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT scan: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
A: Chemo Resistant
n=20 Participants
Group A: chemo resistant - those progressing on first-line therapy \< 3 months after completion of treatment.
Treatment (pegylated irinotecan NKTR 102) Patients receive pegylated irinotecan NKTR 102 IV over 90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Laboratory Biomarker Analysis: Correlative studies Pegylated Irinotecan: Given IV Pharmacological Study: Correlative studies
|
B: Chemo Sensitive
n=18 Participants
Group B: chemo sensitive - those progressing on first-line therapy ≥ 3 months after completion of treatment.
Treatment (pegylated irinotecan NKTR 102) Patients receive pegylated irinotecan NKTR 102 IV over 90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Laboratory Biomarker Analysis: Correlative studies
Pegylated Irinotecan: Given IV
Pharmacological Study: Correlative studies
|
|---|---|---|
|
Best Response
CR Complete Response/Remission
|
0 Participants
|
1 Participants
|
|
Best Response
PR Partial Response/Remission
|
4 Participants
|
6 Participants
|
|
Best Response
SD Stable Disease
|
6 Participants
|
7 Participants
|
|
Best Response
PD Progressive Disease
|
9 Participants
|
2 Participants
|
|
Best Response
NE Not Evaluable
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Time from registration to death due to any cause, assessed up to 3 yearsPopulation: All treated and eligible patients
The distribution of survival time was be estimated in each group using the method of Kaplan-Meier.
Outcome measures
| Measure |
A: Chemo Resistant
n=20 Participants
Group A: chemo resistant - those progressing on first-line therapy \< 3 months after completion of treatment.
Treatment (pegylated irinotecan NKTR 102) Patients receive pegylated irinotecan NKTR 102 IV over 90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Laboratory Biomarker Analysis: Correlative studies Pegylated Irinotecan: Given IV Pharmacological Study: Correlative studies
|
B: Chemo Sensitive
n=18 Participants
Group B: chemo sensitive - those progressing on first-line therapy ≥ 3 months after completion of treatment.
Treatment (pegylated irinotecan NKTR 102) Patients receive pegylated irinotecan NKTR 102 IV over 90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Laboratory Biomarker Analysis: Correlative studies
Pegylated Irinotecan: Given IV
Pharmacological Study: Correlative studies
|
|---|---|---|
|
Median Overall Survival
|
7.4 months
Interval 2.9 to 11.7
|
7.1 months
Interval 4.8 to 14.7
|
SECONDARY outcome
Timeframe: Up to 30 daysPopulation: All treated and eligible patients
Count of participants by maximum graded according to NCI CTCAE v 4.0 of any adverse event by arm. Please refer to the adverse event reporting for more detail.
Outcome measures
| Measure |
A: Chemo Resistant
n=20 Participants
Group A: chemo resistant - those progressing on first-line therapy \< 3 months after completion of treatment.
Treatment (pegylated irinotecan NKTR 102) Patients receive pegylated irinotecan NKTR 102 IV over 90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Laboratory Biomarker Analysis: Correlative studies Pegylated Irinotecan: Given IV Pharmacological Study: Correlative studies
|
B: Chemo Sensitive
n=18 Participants
Group B: chemo sensitive - those progressing on first-line therapy ≥ 3 months after completion of treatment.
Treatment (pegylated irinotecan NKTR 102) Patients receive pegylated irinotecan NKTR 102 IV over 90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Laboratory Biomarker Analysis: Correlative studies
Pegylated Irinotecan: Given IV
Pharmacological Study: Correlative studies
|
|---|---|---|
|
Incidence of Adverse Events, Assessed Using NCI CTCAE v 4.0
Grade 1
|
7 Participants
|
1 Participants
|
|
Incidence of Adverse Events, Assessed Using NCI CTCAE v 4.0
Grade 2
|
3 Participants
|
6 Participants
|
|
Incidence of Adverse Events, Assessed Using NCI CTCAE v 4.0
Grade 3
|
9 Participants
|
9 Participants
|
|
Incidence of Adverse Events, Assessed Using NCI CTCAE v 4.0
Grade 4
|
0 Participants
|
1 Participants
|
|
Incidence of Adverse Events, Assessed Using NCI CTCAE v 4.0
Grade 5
|
0 Participants
|
1 Participants
|
|
Incidence of Adverse Events, Assessed Using NCI CTCAE v 4.0
Grade 0
|
1 Participants
|
0 Participants
|
Adverse Events
A: Chemo Resistant
Serious events: 4 serious events
Other events: 19 other events
Deaths: 0 deaths
B: Chemo Sensitive
Serious events: 4 serious events
Other events: 17 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
A: Chemo Resistant
n=20 participants at risk
Group A: chemo resistant - those progressing on first-line therapy \< 3 months after completion of treatment.
Treatment (pegylated irinotecan NKTR 102) Patients receive pegylated irinotecan NKTR 102 IV over 90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Laboratory Biomarker Analysis: Correlative studies Pegylated Irinotecan: Given IV Pharmacological Study: Correlative studies
|
B: Chemo Sensitive
n=18 participants at risk
Group B: chemo sensitive - those progressing on first-line therapy ≥ 3 months after completion of treatment.
Treatment (pegylated irinotecan NKTR 102) Patients receive pegylated irinotecan NKTR 102 IV over 90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Laboratory Biomarker Analysis: Correlative studies
Pegylated Irinotecan: Given IV
Pharmacological Study: Correlative studies
|
|---|---|---|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/20 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
5.6%
1/18 • Number of events 1 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
|
Gastrointestinal disorders
Diarrhoea
|
10.0%
2/20 • Number of events 4 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
0.00%
0/18 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
|
Gastrointestinal disorders
Gastric ulcer perforation
|
0.00%
0/20 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
5.6%
1/18 • Number of events 1 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
|
Infections and infestations
Diverticulitis
|
5.0%
1/20 • Number of events 1 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
0.00%
0/18 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/20 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
5.6%
1/18 • Number of events 1 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/20 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
5.6%
1/18 • Number of events 1 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
|
Renal and urinary disorders
Renal failure acute
|
5.0%
1/20 • Number of events 3 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
0.00%
0/18 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.0%
1/20 • Number of events 1 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
0.00%
0/18 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
Other adverse events
| Measure |
A: Chemo Resistant
n=20 participants at risk
Group A: chemo resistant - those progressing on first-line therapy \< 3 months after completion of treatment.
Treatment (pegylated irinotecan NKTR 102) Patients receive pegylated irinotecan NKTR 102 IV over 90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Laboratory Biomarker Analysis: Correlative studies Pegylated Irinotecan: Given IV Pharmacological Study: Correlative studies
|
B: Chemo Sensitive
n=18 participants at risk
Group B: chemo sensitive - those progressing on first-line therapy ≥ 3 months after completion of treatment.
Treatment (pegylated irinotecan NKTR 102) Patients receive pegylated irinotecan NKTR 102 IV over 90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Laboratory Biomarker Analysis: Correlative studies
Pegylated Irinotecan: Given IV
Pharmacological Study: Correlative studies
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
25.0%
5/20 • Number of events 9 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
16.7%
3/18 • Number of events 5 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.0%
1/20 • Number of events 1 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
0.00%
0/18 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/20 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
5.6%
1/18 • Number of events 1 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
|
Eye disorders
Eye pain
|
0.00%
0/20 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
5.6%
1/18 • Number of events 1 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/20 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
5.6%
1/18 • Number of events 1 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
|
Eye disorders
Photopsia
|
5.0%
1/20 • Number of events 1 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
0.00%
0/18 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
|
Eye disorders
Vision blurred
|
5.0%
1/20 • Number of events 2 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
16.7%
3/18 • Number of events 10 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/20 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
5.6%
1/18 • Number of events 1 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
|
Gastrointestinal disorders
Abdominal pain
|
15.0%
3/20 • Number of events 3 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
22.2%
4/18 • Number of events 7 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/20 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
5.6%
1/18 • Number of events 1 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
10.0%
2/20 • Number of events 2 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
0.00%
0/18 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/20 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
16.7%
3/18 • Number of events 6 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
|
Gastrointestinal disorders
Diarrhoea
|
50.0%
10/20 • Number of events 25 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
66.7%
12/18 • Number of events 33 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
|
Gastrointestinal disorders
Dry mouth
|
15.0%
3/20 • Number of events 3 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
0.00%
0/18 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/20 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
5.6%
1/18 • Number of events 1 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
|
Gastrointestinal disorders
Eructation
|
5.0%
1/20 • Number of events 2 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
0.00%
0/18 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
|
Gastrointestinal disorders
Flatulence
|
10.0%
2/20 • Number of events 3 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
5.6%
1/18 • Number of events 1 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
|
Gastrointestinal disorders
Nausea
|
35.0%
7/20 • Number of events 13 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
55.6%
10/18 • Number of events 16 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
|
Gastrointestinal disorders
Retching
|
5.0%
1/20 • Number of events 1 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
0.00%
0/18 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
|
Gastrointestinal disorders
Vomiting
|
30.0%
6/20 • Number of events 10 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
27.8%
5/18 • Number of events 13 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
|
General disorders
Asthenia
|
0.00%
0/20 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
5.6%
1/18 • Number of events 1 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
|
General disorders
Chills
|
0.00%
0/20 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
5.6%
1/18 • Number of events 1 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
|
General disorders
Fatigue
|
35.0%
7/20 • Number of events 13 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
38.9%
7/18 • Number of events 11 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
|
General disorders
Gait disturbance
|
0.00%
0/20 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
5.6%
1/18 • Number of events 1 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
|
General disorders
Malaise
|
5.0%
1/20 • Number of events 1 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
5.6%
1/18 • Number of events 1 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
|
General disorders
Oedema
|
0.00%
0/20 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
5.6%
1/18 • Number of events 1 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
|
General disorders
Oedema peripheral
|
0.00%
0/20 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
5.6%
1/18 • Number of events 1 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
|
General disorders
Pyrexia
|
0.00%
0/20 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
5.6%
1/18 • Number of events 2 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/20 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
5.6%
1/18 • Number of events 1 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
|
Infections and infestations
Candidiasis
|
0.00%
0/20 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
5.6%
1/18 • Number of events 2 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
|
Infections and infestations
Pelvic abscess
|
5.0%
1/20 • Number of events 1 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
0.00%
0/18 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/20 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
5.6%
1/18 • Number of events 1 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
|
Injury, poisoning and procedural complications
Contusion
|
5.0%
1/20 • Number of events 1 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
0.00%
0/18 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
|
Investigations
Alanine aminotransferase
|
0.00%
0/20 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
5.6%
1/18 • Number of events 1 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
|
Investigations
Aspartate aminotransferase
|
0.00%
0/20 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
11.1%
2/18 • Number of events 4 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
|
Investigations
Blood alkaline phosphatase
|
0.00%
0/20 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
5.6%
1/18 • Number of events 2 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
|
Investigations
Blood creatinine
|
5.0%
1/20 • Number of events 4 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
0.00%
0/18 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
|
Investigations
Haemoglobin
|
5.0%
1/20 • Number of events 6 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
22.2%
4/18 • Number of events 6 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
|
Investigations
Lymphocyte count decreased
|
20.0%
4/20 • Number of events 9 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
22.2%
4/18 • Number of events 9 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
|
Investigations
Neutrophil count decreased
|
20.0%
4/20 • Number of events 15 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
11.1%
2/18 • Number of events 2 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
|
Investigations
Platelet count decreased
|
10.0%
2/20 • Number of events 2 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
0.00%
0/18 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
|
Investigations
Weight decreased
|
35.0%
7/20 • Number of events 9 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
22.2%
4/18 • Number of events 5 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
|
Investigations
White blood cell count decreased
|
30.0%
6/20 • Number of events 21 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
16.7%
3/18 • Number of events 6 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
15.0%
3/20 • Number of events 4 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
38.9%
7/18 • Number of events 12 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
|
Metabolism and nutrition disorders
Dehydration
|
5.0%
1/20 • Number of events 2 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
5.6%
1/18 • Number of events 1 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/20 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
16.7%
3/18 • Number of events 3 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
5.0%
1/20 • Number of events 1 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
5.6%
1/18 • Number of events 1 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
15.0%
3/20 • Number of events 4 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
5.6%
1/18 • Number of events 1 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
10.0%
2/20 • Number of events 4 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
22.2%
4/18 • Number of events 6 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.0%
1/20 • Number of events 1 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
0.00%
0/18 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
5.0%
1/20 • Number of events 1 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
11.1%
2/18 • Number of events 4 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/20 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
11.1%
2/18 • Number of events 2 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.0%
1/20 • Number of events 1 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
0.00%
0/18 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
|
Nervous system disorders
Amputation stump pain
|
0.00%
0/20 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
5.6%
1/18 • Number of events 1 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
|
Nervous system disorders
Dizziness
|
5.0%
1/20 • Number of events 1 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
16.7%
3/18 • Number of events 6 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
|
Nervous system disorders
Dysgeusia
|
10.0%
2/20 • Number of events 2 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
11.1%
2/18 • Number of events 2 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
|
Nervous system disorders
Headache
|
5.0%
1/20 • Number of events 1 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
5.6%
1/18 • Number of events 1 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/20 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
5.6%
1/18 • Number of events 1 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/20 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
5.6%
1/18 • Number of events 1 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/20 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
5.6%
1/18 • Number of events 2 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/20 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
11.1%
2/18 • Number of events 3 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.0%
1/20 • Number of events 1 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
5.6%
1/18 • Number of events 1 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
10.0%
2/20 • Number of events 2 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
5.6%
1/18 • Number of events 1 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
5.0%
1/20 • Number of events 1 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
0.00%
0/18 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
5.0%
1/20 • Number of events 1 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
0.00%
0/18 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/20 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
5.6%
1/18 • Number of events 1 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/20 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
11.1%
2/18 • Number of events 2 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/20 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
5.6%
1/18 • Number of events 1 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
|
Vascular disorders
Superior vena cava syndrome
|
5.0%
1/20 • Number of events 1 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
0.00%
0/18 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
|
Vascular disorders
Vasodilatation
|
5.0%
1/20 • Number of events 1 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
0.00%
0/18 • From time of Cycle 1 Day 1 until 30 days after receiving last dose of study drug, an average of 4 months (range 1 to 21 months).
|
Additional Information
Senior Administrator, Compliance - Clinical Research Services
Roswell Park Cancer Institute
Phone: 716-845-2300
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place