Trial Outcomes & Findings for Study of ADI-PEG 20 in Patients With Relapsed Sensitive or Refractory Small Cell Lung Cancer (NCT NCT01266018)
NCT ID: NCT01266018
Last Updated: 2022-10-25
Results Overview
Tumor responses were evaluated using any appropriate imaging type and were categorized according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Per RECIST for target lesions and assessed by MRI: Complete Response (CR): Disappearance of all target lesions \[no evidence of disease\]; Partial Response (PR): ≥ 30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD): ≥ 20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD): small changes that do not meet above criteria.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
22 participants
Primary outcome timeframe
Every 4 to 8 weeks for up to 16 weeks
Results posted on
2022-10-25
Participant Flow
Participant milestones
| Measure |
Cohort 1: Sensitive Disease
Cohort 1 comprised subjects with "sensitive" disease, defined as subjects who were treated with 1 previous line of chemotherapy and maintained an appropriate response for 90 days or more.
|
Cohort 2: Refractory Disease
Cohort 2 comprised subjects with "refractory" disease, defined as subjects who either (a) were treated with 1 previous line of chemotherapy and either had no response or progressed \< 90 days after completing treatment or (b) required third-line therapy, i.e., had completed 2 previous lines of chemotherapy, regardless of response
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
13
|
|
Overall Study
COMPLETED
|
8
|
12
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Cohort 1: Sensitive Disease
Cohort 1 comprised subjects with "sensitive" disease, defined as subjects who were treated with 1 previous line of chemotherapy and maintained an appropriate response for 90 days or more.
|
Cohort 2: Refractory Disease
Cohort 2 comprised subjects with "refractory" disease, defined as subjects who either (a) were treated with 1 previous line of chemotherapy and either had no response or progressed \< 90 days after completing treatment or (b) required third-line therapy, i.e., had completed 2 previous lines of chemotherapy, regardless of response
|
|---|---|---|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Progressive disease
|
0
|
1
|
Baseline Characteristics
Study of ADI-PEG 20 in Patients With Relapsed Sensitive or Refractory Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
All Enrolled Subjects
n=22 Participants
Includes all subjects enrolled in Cohort 1 (n = 9) and Cohort 2 (n = 13).
|
|---|---|
|
Age, Continuous
|
63.4 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
1 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
|
Region of Enrollment
Taiwan
|
6 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
3 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
1 participants
n=5 Participants
|
|
Body mass index
|
28.3 kg/m^2
STANDARD_DEVIATION 5.6 • n=5 Participants
|
|
Argininosuccinate Synthetase (ASS) Assay Result
Negative
|
11 participants
n=5 Participants
|
|
Argininosuccinate Synthetase (ASS) Assay Result
<5% cells positive
|
11 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Every 4 to 8 weeks for up to 16 weeksPopulation: Includes all patients who were evaluable for tumor response allocation.
Tumor responses were evaluated using any appropriate imaging type and were categorized according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Per RECIST for target lesions and assessed by MRI: Complete Response (CR): Disappearance of all target lesions \[no evidence of disease\]; Partial Response (PR): ≥ 30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD): ≥ 20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD): small changes that do not meet above criteria.
Outcome measures
| Measure |
Cohort 1: Sensitive Disease
n=8 Participants
Includes subjects with "sensitive" disease, defined as subjects who were treated with 1 previous line of chemotherapy and maintained an appropriate response for 90 days or more.
|
Cohort 2: Refractory Disease
n=12 Participants
Includes subjects with "refractory" disease, defined as subjects who either (a) were treated with 1 previous line of chemotherapy and either had no response or progressed \< 90 days after completing treatment or (b) required third-line therapy, i.e., had completed 2 previous lines of chemotherapy, regardless of response.
|
|---|---|---|
|
Best Overall Response
Stable disease
|
2 participants
|
2 participants
|
|
Best Overall Response
Progressive disease
|
6 participants
|
10 participants
|
SECONDARY outcome
Timeframe: Every 1 to 4 weeks for up to 16 weeksPopulation: The Safety Analysis Set comprises all subjects who received at least 1 dose of study drug.
Analysis of treatment-emergent adverse events (TEAEs) reported from clinical laboratory tests, physical examinations, and vital signs.
Outcome measures
| Measure |
Cohort 1: Sensitive Disease
n=9 Participants
Includes subjects with "sensitive" disease, defined as subjects who were treated with 1 previous line of chemotherapy and maintained an appropriate response for 90 days or more.
|
Cohort 2: Refractory Disease
n=13 Participants
Includes subjects with "refractory" disease, defined as subjects who either (a) were treated with 1 previous line of chemotherapy and either had no response or progressed \< 90 days after completing treatment or (b) required third-line therapy, i.e., had completed 2 previous lines of chemotherapy, regardless of response.
|
|---|---|---|
|
Assessment of Safety of Arginine Deiminase Pegylated (ADI-PEG) 20
Any TEAE
|
9 participants
|
12 participants
|
|
Assessment of Safety of Arginine Deiminase Pegylated (ADI-PEG) 20
Grade 3 TEAE
|
5 participants
|
1 participants
|
|
Assessment of Safety of Arginine Deiminase Pegylated (ADI-PEG) 20
Grade 4 TEAE
|
1 participants
|
2 participants
|
|
Assessment of Safety of Arginine Deiminase Pegylated (ADI-PEG) 20
Grade 5 TEAE (Death)
|
0 participants
|
3 participants
|
|
Assessment of Safety of Arginine Deiminase Pegylated (ADI-PEG) 20
Treatment-related TEAE
|
4 participants
|
7 participants
|
|
Assessment of Safety of Arginine Deiminase Pegylated (ADI-PEG) 20
Serious TEAE
|
5 participants
|
5 participants
|
|
Assessment of Safety of Arginine Deiminase Pegylated (ADI-PEG) 20
TEAE leading to withdrawal
|
0 participants
|
3 participants
|
SECONDARY outcome
Timeframe: Every 1 to 4 weeks for up to 16 weeksPopulation: The Pharmacodynamic Analysis Set comprises all subjects who received at least 1 dose of study drug and provided plasma samples for pharmacodynamic analyses. A total of 121 plasma samples from 21 subjects were analyzed. Summary data are presented through Day 58, i.e., the last time point with at least 3 samples available for calculation of a mean.
Blood samples were collected from all subjects at enrollment, prior to each treatment, and at the end of study to evaluate changes in plasma arginine and citrulline levels following administration of ADI-PEG 20. Disease state (ie, relapsed sensitive vs refractory) was not considered relevant to this analysis and as such samples were collected without regard for cohort assignment.
Outcome measures
| Measure |
Cohort 1: Sensitive Disease
n=21 Participants
Includes subjects with "sensitive" disease, defined as subjects who were treated with 1 previous line of chemotherapy and maintained an appropriate response for 90 days or more.
|
Cohort 2: Refractory Disease
Includes subjects with "refractory" disease, defined as subjects who either (a) were treated with 1 previous line of chemotherapy and either had no response or progressed \< 90 days after completing treatment or (b) required third-line therapy, i.e., had completed 2 previous lines of chemotherapy, regardless of response.
|
|---|---|---|
|
Assessment of Pharmacodynamics of ADI-PEG 20
Arginine (Day 0)
|
69 uM
Interval 39.0 to 96.0
|
—
|
|
Assessment of Pharmacodynamics of ADI-PEG 20
Arginine (Day 1)
|
110 uM
Interval 26.0 to 321.0
|
—
|
|
Assessment of Pharmacodynamics of ADI-PEG 20
Arginine (Day 8)
|
2 uM
Interval 1.0 to 5.0
|
—
|
|
Assessment of Pharmacodynamics of ADI-PEG 20
Arginine (Day 15)
|
2 uM
Interval 1.0 to 5.0
|
—
|
|
Assessment of Pharmacodynamics of ADI-PEG 20
Arginine (Day 22)
|
3 uM
Interval 1.0 to 12.0
|
—
|
|
Assessment of Pharmacodynamics of ADI-PEG 20
Arginine (Day 29)
|
2 uM
Interval 1.0 to 5.0
|
—
|
|
Assessment of Pharmacodynamics of ADI-PEG 20
Arginine (Day 36)
|
16 uM
Interval 1.0 to 105.0
|
—
|
|
Assessment of Pharmacodynamics of ADI-PEG 20
Arginine (Day 43)
|
11 uM
Interval 1.0 to 67.0
|
—
|
|
Assessment of Pharmacodynamics of ADI-PEG 20
Arginine (Day 50)
|
29 uM
Interval 1.0 to 69.0
|
—
|
|
Assessment of Pharmacodynamics of ADI-PEG 20
Arginine (Day 58)
|
52 uM
Interval 1.0 to 113.0
|
—
|
|
Assessment of Pharmacodynamics of ADI-PEG 20
Citrulline (Day 0)
|
26 uM
Interval 14.0 to 40.0
|
—
|
|
Assessment of Pharmacodynamics of ADI-PEG 20
Citrulline (Day 1)
|
46 uM
Interval 9.0 to 232.0
|
—
|
|
Assessment of Pharmacodynamics of ADI-PEG 20
Citrulline (Day 8)
|
546 uM
Interval 91.0 to 912.0
|
—
|
|
Assessment of Pharmacodynamics of ADI-PEG 20
Citrulline (Day 15)
|
684 uM
Interval 136.0 to 1190.0
|
—
|
|
Assessment of Pharmacodynamics of ADI-PEG 20
Citrulline (Day 22)
|
495 uM
Interval 71.0 to 1130.0
|
—
|
|
Assessment of Pharmacodynamics of ADI-PEG 20
Citrulline (Day 29)
|
409 uM
Interval 91.0 to 982.0
|
—
|
|
Assessment of Pharmacodynamics of ADI-PEG 20
Citrulline (Day 36)
|
223 uM
Interval 15.0 to 367.0
|
—
|
|
Assessment of Pharmacodynamics of ADI-PEG 20
Citrulline (Day 43)
|
222 uM
Interval 60.0 to 530.0
|
—
|
|
Assessment of Pharmacodynamics of ADI-PEG 20
Citrulline (Day 50)
|
222 uM
Interval 42.0 to 632.0
|
—
|
|
Assessment of Pharmacodynamics of ADI-PEG 20
Citrulline (Day 58)
|
119 uM
Interval 43.0 to 316.0
|
—
|
SECONDARY outcome
Timeframe: Every 1 to 4 weeks for up to 16 weeksPopulation: The Pharmacodynamic Analysis Set comprises all subjects who received at least 1 dose of study drug and provided plasma samples for pharmacodynamic analyses. A total of 121 plasma samples from 21 subjects were analyzed. Summary data are presented through Day 58, i.e., the last time point with at least 3 samples available for calculation of a mean.
Blood samples were collected for all subjects at enrollment, prior to each treatment, and at the end of study to evaluate changes in ADI-PEG 20 antibody titer in peripheral blood over time. Disease state (ie, relapsed sensitive vs refractory) was not considered relevant to this analysis and as such samples were collected without regard for cohort assignment.
Outcome measures
| Measure |
Cohort 1: Sensitive Disease
n=21 Participants
Includes subjects with "sensitive" disease, defined as subjects who were treated with 1 previous line of chemotherapy and maintained an appropriate response for 90 days or more.
|
Cohort 2: Refractory Disease
Includes subjects with "refractory" disease, defined as subjects who either (a) were treated with 1 previous line of chemotherapy and either had no response or progressed \< 90 days after completing treatment or (b) required third-line therapy, i.e., had completed 2 previous lines of chemotherapy, regardless of response.
|
|---|---|---|
|
Assessment of Immunogenicity of ADI-PEG 20
Antibody titer (Day 0)
|
0.7 log 10 IU/mL
Interval 0.0 to 2.0
|
—
|
|
Assessment of Immunogenicity of ADI-PEG 20
Antibody titer (Day 1)
|
0.5 log 10 IU/mL
Interval 0.0 to 2.0
|
—
|
|
Assessment of Immunogenicity of ADI-PEG 20
Antibody titer (Day 8)
|
0.4 log 10 IU/mL
Interval 0.0 to 2.0
|
—
|
|
Assessment of Immunogenicity of ADI-PEG 20
Antibody titer (Day 15)
|
1.4 log 10 IU/mL
Interval 0.0 to 3.0
|
—
|
|
Assessment of Immunogenicity of ADI-PEG 20
Antibody titer (Day 22)
|
1.5 log 10 IU/mL
Interval 0.0 to 4.0
|
—
|
|
Assessment of Immunogenicity of ADI-PEG 20
Antibody titer (Day 29)
|
1.3 log 10 IU/mL
Interval 0.0 to 3.0
|
—
|
|
Assessment of Immunogenicity of ADI-PEG 20
Antibody titer (Day 36)
|
1.9 log 10 IU/mL
Interval 0.0 to 5.0
|
—
|
|
Assessment of Immunogenicity of ADI-PEG 20
Antibody titer (Day 43)
|
2.2 log 10 IU/mL
Interval 0.0 to 4.0
|
—
|
|
Assessment of Immunogenicity of ADI-PEG 20
Antibody titer (Day 50)
|
3.4 log 10 IU/mL
Interval 1.0 to 6.0
|
—
|
|
Assessment of Immunogenicity of ADI-PEG 20
Antibody titer (Day 58)
|
4.0 log 10 IU/mL
Interval 3.0 to 5.0
|
—
|
SECONDARY outcome
Timeframe: Every 4 weeks for up to 16 monthsPopulation: Subjects who had survival status recorded during post-study follow-up.
Overall survival was measured from the initial date of treatment to the recorded date of death. Because the study was terminated prematurely, no statistical analyses of overall survival data were performed.
Outcome measures
| Measure |
Cohort 1: Sensitive Disease
n=6 Participants
Includes subjects with "sensitive" disease, defined as subjects who were treated with 1 previous line of chemotherapy and maintained an appropriate response for 90 days or more.
|
Cohort 2: Refractory Disease
n=11 Participants
Includes subjects with "refractory" disease, defined as subjects who either (a) were treated with 1 previous line of chemotherapy and either had no response or progressed \< 90 days after completing treatment or (b) required third-line therapy, i.e., had completed 2 previous lines of chemotherapy, regardless of response.
|
|---|---|---|
|
Assessment of Overall Survival
Alive at last follow-up
|
4 Participants
|
4 Participants
|
|
Assessment of Overall Survival
Not alive at last follow-up
|
2 Participants
|
7 Participants
|
Adverse Events
All Subjects (Safety Analysis Set)
Serious events: 10 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
All Subjects (Safety Analysis Set)
n=22 participants at risk
Includes all subjects in Cohort 1 (n = 9) and Cohort 2 (n = 13) who received at least 1 dose of study drug.
|
|---|---|
|
Blood and lymphatic system disorders
Lymphopenia
|
4.5%
1/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs occurring after the first dose of study drug were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using NCI CTCAE (v4.0), seriousness, study drug action taken, treatment, and outcome. In summaries, treatment-related AEs included those with a "possible", "probable", or "definite" relationship to study drug; preferred terms were counted only once per subject at the maximum reported grade.
|
|
Blood and lymphatic system disorders
Neutropenia
|
4.5%
1/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs occurring after the first dose of study drug were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using NCI CTCAE (v4.0), seriousness, study drug action taken, treatment, and outcome. In summaries, treatment-related AEs included those with a "possible", "probable", or "definite" relationship to study drug; preferred terms were counted only once per subject at the maximum reported grade.
|
|
Cardiac disorders
Cardiac arrest
|
4.5%
1/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs occurring after the first dose of study drug were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using NCI CTCAE (v4.0), seriousness, study drug action taken, treatment, and outcome. In summaries, treatment-related AEs included those with a "possible", "probable", or "definite" relationship to study drug; preferred terms were counted only once per subject at the maximum reported grade.
|
|
General disorders
Non-cardiac chest pain
|
4.5%
1/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs occurring after the first dose of study drug were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using NCI CTCAE (v4.0), seriousness, study drug action taken, treatment, and outcome. In summaries, treatment-related AEs included those with a "possible", "probable", or "definite" relationship to study drug; preferred terms were counted only once per subject at the maximum reported grade.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
9.1%
2/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs occurring after the first dose of study drug were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using NCI CTCAE (v4.0), seriousness, study drug action taken, treatment, and outcome. In summaries, treatment-related AEs included those with a "possible", "probable", or "definite" relationship to study drug; preferred terms were counted only once per subject at the maximum reported grade.
|
|
Nervous system disorders
Hypoaesthesia
|
4.5%
1/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs occurring after the first dose of study drug were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using NCI CTCAE (v4.0), seriousness, study drug action taken, treatment, and outcome. In summaries, treatment-related AEs included those with a "possible", "probable", or "definite" relationship to study drug; preferred terms were counted only once per subject at the maximum reported grade.
|
|
Nervous system disorders
Paraesthesia
|
4.5%
1/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs occurring after the first dose of study drug were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using NCI CTCAE (v4.0), seriousness, study drug action taken, treatment, and outcome. In summaries, treatment-related AEs included those with a "possible", "probable", or "definite" relationship to study drug; preferred terms were counted only once per subject at the maximum reported grade.
|
|
Nervous system disorders
Somnolence
|
4.5%
1/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs occurring after the first dose of study drug were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using NCI CTCAE (v4.0), seriousness, study drug action taken, treatment, and outcome. In summaries, treatment-related AEs included those with a "possible", "probable", or "definite" relationship to study drug; preferred terms were counted only once per subject at the maximum reported grade.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
13.6%
3/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs occurring after the first dose of study drug were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using NCI CTCAE (v4.0), seriousness, study drug action taken, treatment, and outcome. In summaries, treatment-related AEs included those with a "possible", "probable", or "definite" relationship to study drug; preferred terms were counted only once per subject at the maximum reported grade.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
4.5%
1/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs occurring after the first dose of study drug were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using NCI CTCAE (v4.0), seriousness, study drug action taken, treatment, and outcome. In summaries, treatment-related AEs included those with a "possible", "probable", or "definite" relationship to study drug; preferred terms were counted only once per subject at the maximum reported grade.
|
|
Blood and lymphatic system disorders
Leukopenia
|
4.5%
1/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs occurring after the first dose of study drug were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using NCI CTCAE (v4.0), seriousness, study drug action taken, treatment, and outcome. In summaries, treatment-related AEs included those with a "possible", "probable", or "definite" relationship to study drug; preferred terms were counted only once per subject at the maximum reported grade.
|
Other adverse events
| Measure |
All Subjects (Safety Analysis Set)
n=22 participants at risk
Includes all subjects in Cohort 1 (n = 9) and Cohort 2 (n = 13) who received at least 1 dose of study drug.
|
|---|---|
|
Cardiac disorders
Tachycardia
|
9.1%
2/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs occurring after the first dose of study drug were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using NCI CTCAE (v4.0), seriousness, study drug action taken, treatment, and outcome. In summaries, treatment-related AEs included those with a "possible", "probable", or "definite" relationship to study drug; preferred terms were counted only once per subject at the maximum reported grade.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
18.2%
4/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs occurring after the first dose of study drug were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using NCI CTCAE (v4.0), seriousness, study drug action taken, treatment, and outcome. In summaries, treatment-related AEs included those with a "possible", "probable", or "definite" relationship to study drug; preferred terms were counted only once per subject at the maximum reported grade.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
13.6%
3/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs occurring after the first dose of study drug were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using NCI CTCAE (v4.0), seriousness, study drug action taken, treatment, and outcome. In summaries, treatment-related AEs included those with a "possible", "probable", or "definite" relationship to study drug; preferred terms were counted only once per subject at the maximum reported grade.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
9.1%
2/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs occurring after the first dose of study drug were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using NCI CTCAE (v4.0), seriousness, study drug action taken, treatment, and outcome. In summaries, treatment-related AEs included those with a "possible", "probable", or "definite" relationship to study drug; preferred terms were counted only once per subject at the maximum reported grade.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
9.1%
2/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs occurring after the first dose of study drug were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using NCI CTCAE (v4.0), seriousness, study drug action taken, treatment, and outcome. In summaries, treatment-related AEs included those with a "possible", "probable", or "definite" relationship to study drug; preferred terms were counted only once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Constipation
|
18.2%
4/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs occurring after the first dose of study drug were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using NCI CTCAE (v4.0), seriousness, study drug action taken, treatment, and outcome. In summaries, treatment-related AEs included those with a "possible", "probable", or "definite" relationship to study drug; preferred terms were counted only once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Nausea
|
18.2%
4/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs occurring after the first dose of study drug were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using NCI CTCAE (v4.0), seriousness, study drug action taken, treatment, and outcome. In summaries, treatment-related AEs included those with a "possible", "probable", or "definite" relationship to study drug; preferred terms were counted only once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Vomiting
|
18.2%
4/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs occurring after the first dose of study drug were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using NCI CTCAE (v4.0), seriousness, study drug action taken, treatment, and outcome. In summaries, treatment-related AEs included those with a "possible", "probable", or "definite" relationship to study drug; preferred terms were counted only once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Diarrhoea
|
13.6%
3/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs occurring after the first dose of study drug were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using NCI CTCAE (v4.0), seriousness, study drug action taken, treatment, and outcome. In summaries, treatment-related AEs included those with a "possible", "probable", or "definite" relationship to study drug; preferred terms were counted only once per subject at the maximum reported grade.
|
|
General disorders
Fatigue
|
45.5%
10/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs occurring after the first dose of study drug were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using NCI CTCAE (v4.0), seriousness, study drug action taken, treatment, and outcome. In summaries, treatment-related AEs included those with a "possible", "probable", or "definite" relationship to study drug; preferred terms were counted only once per subject at the maximum reported grade.
|
|
General disorders
Asthenia
|
18.2%
4/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs occurring after the first dose of study drug were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using NCI CTCAE (v4.0), seriousness, study drug action taken, treatment, and outcome. In summaries, treatment-related AEs included those with a "possible", "probable", or "definite" relationship to study drug; preferred terms were counted only once per subject at the maximum reported grade.
|
|
General disorders
Chest discomfort
|
9.1%
2/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs occurring after the first dose of study drug were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using NCI CTCAE (v4.0), seriousness, study drug action taken, treatment, and outcome. In summaries, treatment-related AEs included those with a "possible", "probable", or "definite" relationship to study drug; preferred terms were counted only once per subject at the maximum reported grade.
|
|
Infections and infestations
Lower respiratory tract infection
|
9.1%
2/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs occurring after the first dose of study drug were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using NCI CTCAE (v4.0), seriousness, study drug action taken, treatment, and outcome. In summaries, treatment-related AEs included those with a "possible", "probable", or "definite" relationship to study drug; preferred terms were counted only once per subject at the maximum reported grade.
|
|
Investigations
White blood cell count decreased
|
18.2%
4/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs occurring after the first dose of study drug were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using NCI CTCAE (v4.0), seriousness, study drug action taken, treatment, and outcome. In summaries, treatment-related AEs included those with a "possible", "probable", or "definite" relationship to study drug; preferred terms were counted only once per subject at the maximum reported grade.
|
|
Investigations
Platelet count decreased
|
13.6%
3/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs occurring after the first dose of study drug were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using NCI CTCAE (v4.0), seriousness, study drug action taken, treatment, and outcome. In summaries, treatment-related AEs included those with a "possible", "probable", or "definite" relationship to study drug; preferred terms were counted only once per subject at the maximum reported grade.
|
|
Investigations
Blood creatinine increased
|
9.1%
2/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs occurring after the first dose of study drug were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using NCI CTCAE (v4.0), seriousness, study drug action taken, treatment, and outcome. In summaries, treatment-related AEs included those with a "possible", "probable", or "definite" relationship to study drug; preferred terms were counted only once per subject at the maximum reported grade.
|
|
Investigations
Haemoglobin decreased
|
9.1%
2/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs occurring after the first dose of study drug were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using NCI CTCAE (v4.0), seriousness, study drug action taken, treatment, and outcome. In summaries, treatment-related AEs included those with a "possible", "probable", or "definite" relationship to study drug; preferred terms were counted only once per subject at the maximum reported grade.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
31.8%
7/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs occurring after the first dose of study drug were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using NCI CTCAE (v4.0), seriousness, study drug action taken, treatment, and outcome. In summaries, treatment-related AEs included those with a "possible", "probable", or "definite" relationship to study drug; preferred terms were counted only once per subject at the maximum reported grade.
|
|
Metabolism and nutrition disorders
Dehydration
|
9.1%
2/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs occurring after the first dose of study drug were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using NCI CTCAE (v4.0), seriousness, study drug action taken, treatment, and outcome. In summaries, treatment-related AEs included those with a "possible", "probable", or "definite" relationship to study drug; preferred terms were counted only once per subject at the maximum reported grade.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
9.1%
2/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs occurring after the first dose of study drug were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using NCI CTCAE (v4.0), seriousness, study drug action taken, treatment, and outcome. In summaries, treatment-related AEs included those with a "possible", "probable", or "definite" relationship to study drug; preferred terms were counted only once per subject at the maximum reported grade.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.1%
2/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs occurring after the first dose of study drug were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using NCI CTCAE (v4.0), seriousness, study drug action taken, treatment, and outcome. In summaries, treatment-related AEs included those with a "possible", "probable", or "definite" relationship to study drug; preferred terms were counted only once per subject at the maximum reported grade.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
9.1%
2/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs occurring after the first dose of study drug were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using NCI CTCAE (v4.0), seriousness, study drug action taken, treatment, and outcome. In summaries, treatment-related AEs included those with a "possible", "probable", or "definite" relationship to study drug; preferred terms were counted only once per subject at the maximum reported grade.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
9.1%
2/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs occurring after the first dose of study drug were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using NCI CTCAE (v4.0), seriousness, study drug action taken, treatment, and outcome. In summaries, treatment-related AEs included those with a "possible", "probable", or "definite" relationship to study drug; preferred terms were counted only once per subject at the maximum reported grade.
|
|
Nervous system disorders
Dysgeusia
|
9.1%
2/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs occurring after the first dose of study drug were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using NCI CTCAE (v4.0), seriousness, study drug action taken, treatment, and outcome. In summaries, treatment-related AEs included those with a "possible", "probable", or "definite" relationship to study drug; preferred terms were counted only once per subject at the maximum reported grade.
|
|
Nervous system disorders
Headache
|
9.1%
2/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs occurring after the first dose of study drug were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using NCI CTCAE (v4.0), seriousness, study drug action taken, treatment, and outcome. In summaries, treatment-related AEs included those with a "possible", "probable", or "definite" relationship to study drug; preferred terms were counted only once per subject at the maximum reported grade.
|
|
Psychiatric disorders
Insomnia
|
9.1%
2/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs occurring after the first dose of study drug were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using NCI CTCAE (v4.0), seriousness, study drug action taken, treatment, and outcome. In summaries, treatment-related AEs included those with a "possible", "probable", or "definite" relationship to study drug; preferred terms were counted only once per subject at the maximum reported grade.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
9.1%
2/22 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs occurring after the first dose of study drug were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using NCI CTCAE (v4.0), seriousness, study drug action taken, treatment, and outcome. In summaries, treatment-related AEs included those with a "possible", "probable", or "definite" relationship to study drug; preferred terms were counted only once per subject at the maximum reported grade.
|
Additional Information
Jonathan Skipper PhD
Ludwig Institute for Cancer Research
Phone: 12124501539
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60