A Phase I/II Study to Determine the Maximum Tolerated Dos... | NCT00537511 | Trialant
NCT00537511
Sponsor
Celgene
Status
Terminated
Last Update Posted
Nov 19, 2019Actual
Enrollment
22Actual
Phase
Phase 1Phase 2
Conditions
Carcinoma, Small Cell
Interventions
Pomalidomide
Cisplatin
Etoposide
Countries
United States
Canada
Protocol Section
Identification Module
NCT ID
NCT00537511
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CC-4047-SCLC-002
Secondary IDs
Not provided
Brief Title
A Phase I/II Study to Determine the Maximum Tolerated Dose (MTD) and Safety of CC-4047 (Pomalidomide) Administered in Conjunction With Cisplatin and Etoposide
Official Title
A Multicenter, Phase I/IIA, Open-Label, Dose-Escalation Study to Determine the Maximum Tolerated Dose and To Evaluate the Safety Profile of CC-4047 Administered in Combination With Cisplatin and Etoposide in Patients With Extensive Disease Small Cell Lung Cancer
Acronym
Not provided
Organization
CelgeneINDUSTRY
Status Module
Record Verification Date
Nov 2019
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
This study was terminated for administrative reasons.
Expanded Access Info
No
Start Date
Feb 1, 2008Actual
Primary Completion Date
Nov 1, 2010Actual
Completion Date
Dec 1, 2010Actual
First Submitted Date
Sep 27, 2007
First Submission Date that Met QC Criteria
Sep 27, 2007
First Posted Date
Oct 1, 2007Estimated
Results Waived
Not provided
Results First Submitted Date
Mar 6, 2013
Results First Submitted that Met QC Criteria
Mar 6, 2013
Results First Posted Date
Apr 17, 2013Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Nov 6, 2019
Last Update Posted Date
Nov 19, 2019Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
CelgeneINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to determine the maximum tolerated dose and safety of CC-4047 (pomalidomide) given in combination with cisplatin and etoposide in patients with extensive disease small cell lung cancer.
Oral pomalidomide 1 mg - 5 mg daily (QD) for 14 consecutive days of a 21-day cycle, in combination with intravenous (IV) cisplatin 25 mg/m^2 and IV etoposide 100 mg/m^2 on Days 1, 2 and 3 of each cycle during the dose-finding phase (Treatment and Extension Periods; 6 cycles in total). Dose escalation followed a standard phase 1 3+3 design. Participants continuing took only their pomalidomide dose (monotherapy) for an additional 3-week Recovery Period (14 days of consecutive dosing followed by 7 days of no study medication). Participants continuing took oral pomalidomide 5 mg QD as monotherapy for 14 consecutive days of each 21-day cycle until disease progression in the Maintenance Phase.
The MTD was defined as the highest dose level at which no more than 1 in 6 participants experienced a dose-limiting toxicity (DLT) during the first 21-day cycle of treatment. The MTD Phase included the Treatment period (Cycle 1: Identification of the MTD) and the Extension period (Cycles 2 to 6: Confirmation of Safety of the MTD). (See Secondary Outcome Measure 2 for data on DLTs.)
Cycle 1 (21 days)
Secondary Outcomes
Measure
Description
Time Frame
Number of Participants With Dose Limiting Toxicities (DLTs) During the MTD Phase
For the purposes of determining the MTD (see Primary Outcome Measure), a DLT was defined as any 1 or more of the following: inability to deliver all 3 doses of cisplatin and etoposide due to toxicity; inability to deliver 14 consecutive days of daily pomalidomide dosing because the participant did not tolerate the medication due to any of the following: ≥ grade 3 non-hematological toxicity (excluding alopecia) occurring before Day 14 of pomalidomide dosing; febrile neutropenia (absolute neutrophil count [ANC] <1,000/µL and fever >101ºF, core temperature); grade 4 neutropenia of ≥7 days duration with onset on or before Day 14 of pomalidomide dosing; platelet count <25,000/µL occurring before Day 14 of pomalidomide dosing. National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE), Version 4.0, grades: 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
signature of informed consent
Age >= 18
histologically or cytologically confirmed small cell lung cancer (SCLC)
extensive stage SCLC
Eastern Cooperative Oncology Group (ECOG) Performance Status 0, 1 or 2
brain metastases that are asymptomatic and do not require steroid control
females of child bearing potential must use two forms of birth control
Exclusion Criteria:
pregnant or lactating females
prior use of cytotoxic chemotherapy
surgery within 14 days of study
radiation within 14 days of study
prior therapy with CC-4047 (pomalidomide), lenalidomide or thalidomide
concurrent use or anticipated use of anti-cancer agents
absolute neutrophil count (ANC) < 1500/mm^3
platelets < 100 x 10^3/µL
serum creatinine >2.5 mg/dL
serum glutamic oxaloacetic transaminase (SGOT) or serum glutamic pyruvic transaminase (SGPT) > 3.0 x upper limit of normal (ULN)
serum total bilirubin > 1.8 mg/dL
uncontrolled hypercalcemia
creatinine clearance <50 mL/min
uncontrolled hypertension
neuropathy >= grade 2
body mass index (BMI) >= 40
any other active invasive malignancy requiring treatment
known chronic infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV)
inability or unwillingness to comply with birth control requirements
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Ulf Jungnelius, MD
Celgene Corporation
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Ireland Cancer Center, Case Western Reserve University, Division of Hematology/Oncology
Ellis PM, Jungnelius U, Zhang J, Fandi A, Beck R, Shepherd FA. A phase I study of pomalidomide (CC-4047) in combination with cisplatin and etoposide in patients with extensive-stage small-cell lung cancer. J Thorac Oncol. 2013 Apr;8(4):423-8. doi: 10.1097/JTO.0b013e318282707b.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Not provided
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Pomalidomide (Overall)
Oral pomalidomide 1 mg - 5 mg daily (QD) for 14 consecutive days of a 21-day cycle, in combination with intravenous (IV) cisplatin 25 mg/m^2 and IV etoposide 100 mg/m^2 on Days 1, 2 and 3 of each cycle during the dose-finding phase (Treatment and Extension Periods; 6 cycles in total). Dose escalation followed a standard phase 1 3+3 design. Participants continuing took only their pomalidomide dose (monotherapy) for an additional 3-week Recovery Period (14 days of consecutive dosing followed by 7 days of no study medication). Participants continuing took oral pomalidomide 5 mg QD as monotherapy for 14 consecutive days of each 21-day cycle until disease progression in the Maintenance Phase.
Tumor Response Rate According to Response Evaluation Criteria in Solid Tumors (RECIST)
Investigator's best assessment of response based on RECIST criteria during the MTD phase. For target lesions: Complete Response (CR)=Disappearance of all target lesions; Partial Response (PR)=≥30% decrease in sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD; Progressed Disease (PD)=≥20% increase in sum of LD of target lesions taking as reference the smallest sum LD recorded since treatment started or the appearance of ≥1 new lesions; Stable Disease (SD)=Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference the smallest sum LD since treatment started. For non-target lesions: CR= Disappearance of all non-target lesions and normalization of tumor marker level; Incomplete Response/SD=Persistence of ≥1 non-target lesions and/or maintenance of tumor marker level above normal limits; PD=Appearance of ≥1 new lesions; unequivocal progression of existing non-target lesions.
Cycles 1 -6 (21-day cycles)
Duration of Response
Duration of Response was calculated from first Partial Response (PR) or Complete Response (CR) to disease progression. Duration of response was censored at the last date that the participant was known to be progression-free for: 1) participants who had not progressed at the time of analysis; 2) participants who had been removed from the treatment phase prior to documentation of progression.
From first Partial Response (PR) or Complete Response (CR) to disease progression (maximum of 19.4 weeks)
Overall Survival
Overall Survival was defined as time (in weeks) from enrollment to death. The median is based on Kaplan-Meier estimate, with 95% confidence intervals about the median overall survival. Overall survival was censored at the last time participant was known to be alive for those who were alive at time of analysis.
From enrollment through study termination (approximately 35 months)
Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the MTD (Combination Treatment) Phase
Adverse event (AE) = any noxious, unintended, or untoward medical occurrence occurring at any dose that may appear or worsen in a participant during the course of a study, including new intercurrent illness, worsening concomitant illness, injury, or any concomitant impairment of participant's health, including laboratory test values, regardless of etiology. Serious adverse event (SAE) = any AE which: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. TEAE = any AE occurring or worsening on or after the first treatment with any study drug. Related = suspected by investigator to be related to study treatment. National Cancer Institute [NCI] Common Toxicity Criteria for Adverse Events [CTCAE], Version 4.0, grades: 1 = mild, 2 = moderate, 3 = severe, 4 = life threatening, 5 = death.
Cycles 1-6 (21-day cycles). Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6).
Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Recovery Period or Maintenance (Monotherapy) Phase
Adverse event (AE) = any noxious, unintended, or untoward medical occurrence occurring at any dose that may appear or worsen in a participant during the course of a study, including new intercurrent illness, worsening concomitant illness, injury, or any concomitant impairment of participant's health, including laboratory test values, regardless of etiology. TEAE = any AE occurring or worsening on or after the first treatment with any study drug. 'Related' = suspected by investigator to be related to study treatment. National Cancer Institute [NCI] Common Toxicity Criteria for Adverse Events [CTCAE], Version 4.0, grades: 1 = mild, 2 = moderate, 3 = severe, 4 = life threatening, 5 = death.
Cycle 7 to discontinuation (21-day cycles). Median (full range) duration of exposure (in weeks) to pomalidomide during Maintenance Phase was 5.0 (1.1, 36.0).
Pennsylvania State University
Hershey
Pennsylvania
17033
United States
University of Texas Southwestern Medical Center
Dallas
Texas
75390
United States
Juranvinski Cancer Center - Medical Oncology
Hamilton
Ontario
L8V 5C2
Canada
Princess Margaret Hospital
Toronto
Ontario
M5G 2M9
Canada
Mc Gill University - Department of Oncology - Clinical Research Program
Montreal
Quebec
H2W 1S6
Canada
FG00022 subjects
Intent-to-Treat (ITT) Populaton
FG00022 subjectsITT = all participants enrolled in the study.
Safety Population
FG00022 subjectsSafety = All participants who took ≥1 dose of study treatment.
COMPLETED
FG00017 subjects
NOT COMPLETED
FG0005 subjects
Extension Period (Combination)
Type
Comment
Milestone Data
STARTED
FG00017 subjects
COMPLETED
FG00011 subjects
NOT COMPLETED
FG0006 subjects
Recovery Period (Monotherapy)
Type
Comment
Milestone Data
STARTED
FG00011 subjects
COMPLETED
FG0003 subjects
NOT COMPLETED
FG0008 subjects
Maintenance Phase (Monotherapy)
Type
Comment
Milestone Data
STARTED
FG0008 subjects
COMPLETED
FG0000 subjects
NOT COMPLETED
FG0008 subjects
Safety Population
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Pomalidomide (Overall)
Oral pomalidomide 1 mg - 5 mg daily (QD) for 14 consecutive days of a 21-day cycle, in combination with intravenous (IV) cisplatin 25 mg/m^2 and IV etoposide 100 mg/m^2 on Days 1, 2 and 3 of each cycle during the dose-finding phase (Treatment and Extension Periods; 6 cycles in total). Dose escalation followed a standard phase 1 3+3 design. Participants continuing took only their pomalidomide dose (monotherapy) for an additional 3-week Recovery Period (14 days of consecutive dosing followed by 7 days of no study medication). Participants continuing took oral pomalidomide 5 mg QD as monotherapy for 14 consecutive days of each 21-day cycle until disease progression in the Maintenance Phase.
Denominators
Units
Counts
Participants
BG00022
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00063.9± 8.76
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0004
Male
BG00018
Race/Ethnicity, Customized
Number
participants
Title
Denominators
Categories
Caucasian (White)
Title
Measurements
BG00022
Non-caucasian
Title
Measurements
BG000
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Maximum Tolerated Dose (MTD)
The MTD was defined as the highest dose level at which no more than 1 in 6 participants experienced a dose-limiting toxicity (DLT) during the first 21-day cycle of treatment. The MTD Phase included the Treatment period (Cycle 1: Identification of the MTD) and the Extension period (Cycles 2 to 6: Confirmation of Safety of the MTD). (See Secondary Outcome Measure 2 for data on DLTs.)
Safety Population
Posted
Number
mg
Cycle 1 (21 days)
ID
Title
Description
OG000
Pomalidomide (Overall)
Oral pomalidomide 1 mg - 5 mg daily (QD) for 14 consecutive days of a 21-day cycle, in combination with intravenous (IV) cisplatin 25 mg/m^2 and IV etoposide 100 mg/m^2 on Days 1, 2 and 3 of each cycle during the dose-finding phase (Treatment and Extension Periods; 6 cycles in total). Dose escalation followed a standard phase 1 3+3 design. Participants continuing took only their pomalidomide dose (monotherapy) for an additional 3-week Recovery Period (14 days of consecutive dosing followed by 7 days of no study medication). Participants continuing took oral pomalidomide 5 mg QD as monotherapy for 14 consecutive days of each 21-day cycle until disease progression in the Maintenance Phase.
Units
Counts
Participants
OG00022
Title
Denominators
Categories
Title
Measurements
OG0004
Secondary
Number of Participants With Dose Limiting Toxicities (DLTs) During the MTD Phase
For the purposes of determining the MTD (see Primary Outcome Measure), a DLT was defined as any 1 or more of the following: inability to deliver all 3 doses of cisplatin and etoposide due to toxicity; inability to deliver 14 consecutive days of daily pomalidomide dosing because the participant did not tolerate the medication due to any of the following: ≥ grade 3 non-hematological toxicity (excluding alopecia) occurring before Day 14 of pomalidomide dosing; febrile neutropenia (absolute neutrophil count [ANC] <1,000/µL and fever >101ºF, core temperature); grade 4 neutropenia of ≥7 days duration with onset on or before Day 14 of pomalidomide dosing; platelet count <25,000/µL occurring before Day 14 of pomalidomide dosing. National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE), Version 4.0, grades: 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death.
Safety Population
Posted
Number
participants
Cycles 1 - 6 (21-day cycles)
ID
Title
Description
OG000
Pomalidomide 1 mg
Oral pomalidomide 1 mg QD for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m^2 and etoposide 100 mg/m^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
OG001
Pomalidomide 3 mg
Oral pomalidomide 3 mg QD for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m^2 and etoposide 100 mg/m^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
Secondary
Tumor Response Rate According to Response Evaluation Criteria in Solid Tumors (RECIST)
Investigator's best assessment of response based on RECIST criteria during the MTD phase. For target lesions: Complete Response (CR)=Disappearance of all target lesions; Partial Response (PR)=≥30% decrease in sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD; Progressed Disease (PD)=≥20% increase in sum of LD of target lesions taking as reference the smallest sum LD recorded since treatment started or the appearance of ≥1 new lesions; Stable Disease (SD)=Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference the smallest sum LD since treatment started. For non-target lesions: CR= Disappearance of all non-target lesions and normalization of tumor marker level; Incomplete Response/SD=Persistence of ≥1 non-target lesions and/or maintenance of tumor marker level above normal limits; PD=Appearance of ≥1 new lesions; unequivocal progression of existing non-target lesions.
ITT population. 'Not Assessed' category includes participants who did not have adequate data for response assessment at baseline and/or post-baseline prior to the use of any non-protocol anti-tumor therapy.
Posted
Number
participants
Cycles 1 -6 (21-day cycles)
ID
Title
Description
OG000
Pomalidomide 1 mg
Oral pomalidomide 1 mg QD for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m^2 and etoposide 100 mg/m^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
Secondary
Duration of Response
Duration of Response was calculated from first Partial Response (PR) or Complete Response (CR) to disease progression. Duration of response was censored at the last date that the participant was known to be progression-free for: 1) participants who had not progressed at the time of analysis; 2) participants who had been removed from the treatment phase prior to documentation of progression.
Number of participants in ITT population who were considered Responders.
Posted
Mean
Standard Deviation
weeks
From first Partial Response (PR) or Complete Response (CR) to disease progression (maximum of 19.4 weeks)
ID
Title
Description
OG000
Pomalidomide (Overall)
Oral pomalidomide 1 mg - 5 mg daily (QD) for 14 consecutive days of a 21-day cycle, in combination with intravenous (IV) cisplatin 25 mg/m^2 and IV etoposide 100 mg/m^2 on Days 1, 2 and 3 of each cycle during the dose-finding phase (Treatment and Extension Periods; 6 cycles in total). Dose escalation followed a standard phase 1 3+3 design. Participants continuing took only their pomalidomide dose (monotherapy) for an additional 3-week Recovery Period (14 days of consecutive dosing followed by 7 days of no study medication). Participants continuing took oral pomalidomide 5 mg QD as monotherapy for 14 consecutive days of each 21-day cycle until disease progression in the Maintenance Phase.
Units
Counts
Secondary
Overall Survival
Overall Survival was defined as time (in weeks) from enrollment to death. The median is based on Kaplan-Meier estimate, with 95% confidence intervals about the median overall survival. Overall survival was censored at the last time participant was known to be alive for those who were alive at time of analysis.
Participants in the ITT population.
Posted
Median
95% Confidence Interval
weeks
From enrollment through study termination (approximately 35 months)
ID
Title
Description
OG000
Pomalidomide (Overall)
Oral pomalidomide 1 mg - 5 mg daily (QD) for 14 consecutive days of a 21-day cycle, in combination with intravenous (IV) cisplatin 25 mg/m^2 and IV etoposide 100 mg/m^2 on Days 1, 2 and 3 of each cycle during the dose-finding phase (Treatment and Extension Periods; 6 cycles in total). Dose escalation followed a standard phase 1 3+3 design. Participants continuing took only their pomalidomide dose (monotherapy) for an additional 3-week Recovery Period (14 days of consecutive dosing followed by 7 days of no study medication). Participants continuing took oral pomalidomide 5 mg QD as monotherapy for 14 consecutive days of each 21-day cycle until disease progression in the Maintenance Phase.
Units
Counts
Participants
Secondary
Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the MTD (Combination Treatment) Phase
Adverse event (AE) = any noxious, unintended, or untoward medical occurrence occurring at any dose that may appear or worsen in a participant during the course of a study, including new intercurrent illness, worsening concomitant illness, injury, or any concomitant impairment of participant's health, including laboratory test values, regardless of etiology. Serious adverse event (SAE) = any AE which: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. TEAE = any AE occurring or worsening on or after the first treatment with any study drug. Related = suspected by investigator to be related to study treatment. National Cancer Institute [NCI] Common Toxicity Criteria for Adverse Events [CTCAE], Version 4.0, grades: 1 = mild, 2 = moderate, 3 = severe, 4 = life threatening, 5 = death.
Safety population
Posted
Number
participants
Cycles 1-6 (21-day cycles). Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6).
ID
Title
Description
OG000
Pomalidomide 1 mg
Participants received daily oral pomalidomide 1 mg for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m^2 and etoposide 100 mg/m^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
Secondary
Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Recovery Period or Maintenance (Monotherapy) Phase
Adverse event (AE) = any noxious, unintended, or untoward medical occurrence occurring at any dose that may appear or worsen in a participant during the course of a study, including new intercurrent illness, worsening concomitant illness, injury, or any concomitant impairment of participant's health, including laboratory test values, regardless of etiology. TEAE = any AE occurring or worsening on or after the first treatment with any study drug. 'Related' = suspected by investigator to be related to study treatment. National Cancer Institute [NCI] Common Toxicity Criteria for Adverse Events [CTCAE], Version 4.0, grades: 1 = mild, 2 = moderate, 3 = severe, 4 = life threatening, 5 = death.
Safety population; participants continuing in the Recovery Period and Maintenance Phase.
Posted
Number
participants
Cycle 7 to discontinuation (21-day cycles). Median (full range) duration of exposure (in weeks) to pomalidomide during Maintenance Phase was 5.0 (1.1, 36.0).
ID
Title
Description
OG000
Pomalidomide (Overall)
Oral pomalidomide 1 mg - 5 mg daily (QD) for 14 consecutive days of a 21-day cycle, in combination with intravenous (IV) cisplatin 25 mg/m^2 and IV etoposide 100 mg/m^2 on Days 1, 2 and 3 of each cycle during the dose-finding phase (Treatment and Extension Periods; 6 cycles in total). Dose escalation followed a standard phase 1 3+3 design. Participants continuing took only their pomalidomide dose (monotherapy) for an additional 3-week Recovery Period (14 days of consecutive dosing followed by 7 days of no study medication). Participants continuing took oral pomalidomide 5 mg QD as monotherapy for 14 consecutive days of each 21-day cycle until disease progression in the Maintenance Phase.
Time Frame
Treatment-emergent adverse events (TEAEs) were defined as any AE occurring or worsening on or after the first treatment of the study medication and within 30 days after the last dose. See Additional Description for duration of exposure for each treatment.
Description
Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6). Pomalidomide (Maintenance Phase): 5.0 (1.1, 36.0).
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Pomalidomide 1 mg
Oral pomalidomide 1 mg QD for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m^2 and etoposide 100 mg/m^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
3
6
6
6
EG001
Pomalidomide 3 mg
Oral pomalidomide 3 mg QD for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m^2 and etoposide 100 mg/m^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
1
4
4
4
EG002
Pomalidomide 4 mg
Oral pomalidomide 4 mg QD for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m^2 and etoposide 100 mg/m^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
3
6
6
6
EG003
Pomalidomide 5 mg
Oral pomalidomide 5 mg QD for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m^2 and etoposide 100 mg/m^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
3
6
6
6
EG004
Pomalidomide (Overall)
Oral pomalidomide 1 mg - 5 mg daily (QD) for 14 consecutive days of a 21-day cycle, in combination with intravenous (IV) cisplatin 25 mg/m^2 and IV etoposide 100 mg/m^2 on Days 1, 2 and 3 of each cycle during the dose-finding phase (Treatment and Extension Periods; 6 cycles in total). Dose escalation followed a standard phase 1 3+3 design. Participants continuing took only their pomalidomide dose (monotherapy) for an additional 3-week Recovery Period (14 days of consecutive dosing followed by 7 days of no study medication). Participants continuing took oral pomalidomide 5 mg QD as monotherapy for 14 consecutive days of each 21-day cycle until disease progression in the Maintenance Phase.
10
22
22
22
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Febrile Neutropenia
Blood and lymphatic system disorders
MedDRA (14.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected4 at risk
EG0020 affected6 at risk
EG0031 affected6 at risk
EG004
Atrioventricular Block Complete
Cardiac disorders
MedDRA (14.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Diverticular Perforation
Gastrointestinal disorders
MedDRA (14.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Fatigue
General disorders
MedDRA (14.0)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Neutropenic Infection
Infections and infestations
MedDRA (14.0)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Sepsis
Infections and infestations
MedDRA (14.0)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Blood Creatinine Increased
Investigations
MedDRA (14.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected4 at risk
EG0021 affected6 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA (14.0)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Breast Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (14.0)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Cerebral Ischaemia
Nervous system disorders
MedDRA (14.0)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Convulsion
Nervous system disorders
MedDRA (14.0)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Pulmonary Embolism
Respiratory, thoracic and mediastinal disorders
MedDRA (14.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected4 at risk
EG0022 affected6 at risk
EG003
Transient Ischaemic Attack
Nervous system disorders
MedDRA (14.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Fatigue
General disorders
MedDRA (14.0)
Systematic Assessment
EG0005 affected6 at risk
EG0014 affected4 at risk
EG0026 affected6 at risk
EG0036 affected6 at risk
EG00421 affected22 at risk
Oedema peripheral
General disorders
MedDRA (14.0)
Systematic Assessment
EG0002 affected6 at risk
EG0011 affected4 at risk
EG0023 affected6 at risk
EG003
Asthenia
General disorders
MedDRA (14.0)
Systematic Assessment
EG0001 affected6 at risk
EG0011 affected4 at risk
EG0020 affected6 at risk
EG003
Chest discomfort
General disorders
MedDRA (14.0)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected4 at risk
EG0021 affected6 at risk
EG003
Chest pain
General disorders
MedDRA (14.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected4 at risk
EG0022 affected6 at risk
EG003
Pyrexia
General disorders
MedDRA (14.0)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected4 at risk
EG0021 affected6 at risk
EG003
Chills
General disorders
MedDRA (14.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected4 at risk
EG0021 affected6 at risk
EG003
Irritability
General disorders
MedDRA (14.0)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Face oedema
General disorders
MedDRA (14.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Facial pain
General disorders
MedDRA (14.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected4 at risk
EG0021 affected6 at risk
EG003
Infusion site reaction
General disorders
MedDRA (14.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Injection site reaction
General disorders
MedDRA (14.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected4 at risk
EG0021 affected6 at risk
EG003
Mucosal inflammation
General disorders
MedDRA (14.0)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (14.0)
Systematic Assessment
EG0003 affected6 at risk
EG0012 affected4 at risk
EG0025 affected6 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA (14.0)
Systematic Assessment
EG0003 affected6 at risk
EG0012 affected4 at risk
EG0024 affected6 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (14.0)
Systematic Assessment
EG0003 affected6 at risk
EG0010 affected4 at risk
EG0021 affected6 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA (14.0)
Systematic Assessment
EG0002 affected6 at risk
EG0010 affected4 at risk
EG0022 affected6 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (14.0)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected4 at risk
EG0022 affected6 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA (14.0)
Systematic Assessment
EG0001 affected6 at risk
EG0011 affected4 at risk
EG0020 affected6 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA (14.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected4 at risk
EG0021 affected6 at risk
EG003
Dental discomfort
Gastrointestinal disorders
MedDRA (14.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected4 at risk
EG0021 affected6 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA (14.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected4 at risk
EG0021 affected6 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA (14.0)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA (14.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Ileus
Gastrointestinal disorders
MedDRA (14.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA (14.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Tooth loss
Gastrointestinal disorders
MedDRA (14.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected4 at risk
EG0020 affected6 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (14.0)
Systematic Assessment
EG0002 affected6 at risk
EG0011 affected4 at risk
EG0024 affected6 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA (14.0)
Systematic Assessment
EG0001 affected6 at risk
EG0012 affected4 at risk
EG0020 affected6 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA (14.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected4 at risk
EG0021 affected6 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA (14.0)
Systematic Assessment
EG0001 affected6 at risk
EG0011 affected4 at risk
EG0020 affected6 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA (14.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected4 at risk
EG0020 affected6 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA (14.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Allergic sinusitis
Respiratory, thoracic and mediastinal disorders
MedDRA (14.0)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
MedDRA (14.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected4 at risk
EG0020 affected6 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA (14.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected4 at risk
EG0021 affected6 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA (14.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Pleurisy
Respiratory, thoracic and mediastinal disorders
MedDRA (14.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA (14.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected4 at risk
EG0021 affected6 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA (14.0)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA (14.0)
Systematic Assessment
EG0002 affected6 at risk
EG0013 affected4 at risk
EG0022 affected6 at risk
EG003
Dizziness
Nervous system disorders
MedDRA (14.0)
Systematic Assessment
EG0003 affected6 at risk
EG0010 affected4 at risk
EG0021 affected6 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA (14.0)
Systematic Assessment
EG0002 affected6 at risk
EG0012 affected4 at risk
EG0022 affected6 at risk
EG003
Headache
Nervous system disorders
MedDRA (14.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected4 at risk
EG0024 affected6 at risk
EG003
Tremor
Nervous system disorders
MedDRA (14.0)
Systematic Assessment
EG0002 affected6 at risk
EG0010 affected4 at risk
EG0021 affected6 at risk
EG003
Memory impairment
Nervous system disorders
MedDRA (14.0)
Systematic Assessment
EG0001 affected6 at risk
EG0011 affected4 at risk
EG0020 affected6 at risk
EG003
Apraxia
Nervous system disorders
MedDRA (14.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Ataxia
Nervous system disorders
MedDRA (14.0)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Convulsion
Nervous system disorders
MedDRA (14.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected4 at risk
EG0021 affected6 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA (14.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Lethargy
Nervous system disorders
MedDRA (14.0)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Speech disorder
Nervous system disorders
MedDRA (14.0)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Syncope
Nervous system disorders
MedDRA (14.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0003 affected6 at risk
EG0013 affected4 at risk
EG0021 affected6 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0001 affected6 at risk
EG0011 affected4 at risk
EG0023 affected6 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0001 affected6 at risk
EG0011 affected4 at risk
EG0021 affected6 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected4 at risk
EG0022 affected6 at risk
EG003
Rash erythematous
Skin and subcutaneous tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected4 at risk
EG0021 affected6 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected4 at risk
EG0021 affected6 at risk
EG003
Dermal cyst
Skin and subcutaneous tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Hypoaesthesia facial
Skin and subcutaneous tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected4 at risk
EG0021 affected6 at risk
EG003
Petechiae
Skin and subcutaneous tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Rash pruritic
Skin and subcutaneous tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA (14.0)
Systematic Assessment
EG0002 affected6 at risk
EG0012 affected4 at risk
EG0024 affected6 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA (14.0)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected4 at risk
EG0021 affected6 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA (14.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected4 at risk
EG0021 affected6 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA (14.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA (14.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA (14.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA (14.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA (14.0)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA (14.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Gout
Metabolism and nutrition disorders
MedDRA (14.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA (14.0)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Rhinitis
Infections and infestations
MedDRA (14.0)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA (14.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected4 at risk
EG0021 affected6 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA (14.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected4 at risk
EG0021 affected6 at risk
EG003
Pneumonia
Infections and infestations
MedDRA (14.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected4 at risk
EG0022 affected6 at risk
EG003
Sinusitis
Infections and infestations
MedDRA (14.0)
Systematic Assessment
EG0001 affected6 at risk
EG0011 affected4 at risk
EG0020 affected6 at risk
EG003
Cellulitis
Infections and infestations
MedDRA (14.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected4 at risk
EG0020 affected6 at risk
EG003
Infected cyst
Infections and infestations
MedDRA (14.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected4 at risk
EG0021 affected6 at risk
EG003
Influenza
Infections and infestations
MedDRA (14.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Laryngitis
Infections and infestations
MedDRA (14.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected4 at risk
EG0021 affected6 at risk
EG003
Lobar pneumonia
Infections and infestations
MedDRA (14.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Mastoiditis
Infections and infestations
MedDRA (14.0)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA (14.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected4 at risk
EG0020 affected6 at risk
EG003
Skin infection
Infections and infestations
MedDRA (14.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected4 at risk
EG0021 affected6 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA (14.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (14.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected4 at risk
EG0020 affected6 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA (14.0)
Systematic Assessment
EG0003 affected6 at risk
EG0012 affected4 at risk
EG0023 affected6 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA (14.0)
Systematic Assessment
EG0001 affected6 at risk
EG0012 affected4 at risk
EG0020 affected6 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA (14.0)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA (14.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected4 at risk
EG0021 affected6 at risk
EG003
Pancytopenia
Blood and lymphatic system disorders
MedDRA (14.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA (14.0)
Systematic Assessment
EG0002 affected6 at risk
EG0012 affected4 at risk
EG0022 affected6 at risk
EG003
Weight decreased
Investigations
MedDRA (14.0)
Systematic Assessment
EG0000 affected6 at risk
EG0012 affected4 at risk
EG0020 affected6 at risk
EG003
Blood creatinine increased
Investigations
MedDRA (14.0)
Systematic Assessment
EG0001 affected6 at risk
EG0011 affected4 at risk
EG0020 affected6 at risk
EG003
Platelet count decreased
Investigations
MedDRA (14.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected4 at risk
EG0020 affected6 at risk
EG003
Blood magnesium decreased
Investigations
MedDRA (14.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Blood potassium decreased
Investigations
MedDRA (14.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected4 at risk
EG0020 affected6 at risk
EG003
Creatinine renal clearance decreased
Investigations
MedDRA (14.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected4 at risk
EG0021 affected6 at risk
EG003
Electrocardiogram qt prolonged
Investigations
MedDRA (14.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected4 at risk
EG0020 affected6 at risk
EG003
Electrocardiogram st-t segment abnormal
Investigations
MedDRA (14.0)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Weight increased
Investigations
MedDRA (14.0)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0002 affected6 at risk
EG0012 affected4 at risk
EG0021 affected6 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0001 affected6 at risk
EG0012 affected4 at risk
EG0020 affected6 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0001 affected6 at risk
EG0012 affected4 at risk
EG0020 affected6 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected4 at risk
EG0020 affected6 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0001 affected6 at risk
EG0011 affected4 at risk
EG0020 affected6 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected4 at risk
EG0021 affected6 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected4 at risk
EG0021 affected6 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected4 at risk
EG0020 affected6 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected4 at risk
EG0020 affected6 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected4 at risk
EG0020 affected6 at risk
EG003
Pain in jaw
Musculoskeletal and connective tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected4 at risk
EG0020 affected6 at risk
EG003
Hypotension
Vascular disorders
MedDRA (14.0)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected4 at risk
EG0021 affected6 at risk
EG003
Flushing
Vascular disorders
MedDRA (14.0)
Systematic Assessment
EG0001 affected6 at risk
EG0011 affected4 at risk
EG0020 affected6 at risk
EG003
Phlebitis
Vascular disorders
MedDRA (14.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected4 at risk
EG0021 affected6 at risk
EG003
Thrombophlebitis superficial
Vascular disorders
MedDRA (14.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected4 at risk
EG0020 affected6 at risk
EG003
Thrombosis
Vascular disorders
MedDRA (14.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected4 at risk
EG0020 affected6 at risk
EG003
Depression
Psychiatric disorders
MedDRA (14.0)
Systematic Assessment
EG0001 affected6 at risk
EG0011 affected4 at risk
EG0021 affected6 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA (14.0)
Systematic Assessment
EG0001 affected6 at risk
EG0011 affected4 at risk
EG0020 affected6 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA (14.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected4 at risk
EG0021 affected6 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA (14.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Personality change
Psychiatric disorders
MedDRA (14.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Lacrimation increased
Eye disorders
MedDRA (14.0)
Systematic Assessment
EG0001 affected6 at risk
EG0011 affected4 at risk
EG0020 affected6 at risk
EG003
Vision blurred
Eye disorders
MedDRA (14.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected4 at risk
EG0021 affected6 at risk
EG003
Cataract
Eye disorders
MedDRA (14.0)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Diplopia
Eye disorders
MedDRA (14.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Dry eye
Eye disorders
MedDRA (14.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected4 at risk
EG0021 affected6 at risk
EG003
Eye pain
Eye disorders
MedDRA (14.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Nocturia
Renal and urinary disorders
MedDRA (14.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected4 at risk
EG0021 affected6 at risk
EG003
Urinary incontinence
Renal and urinary disorders
MedDRA (14.0)
Systematic Assessment
EG0001 affected6 at risk
EG0011 affected4 at risk
EG0020 affected6 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA (14.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected4 at risk
EG0020 affected6 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA (14.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected4 at risk
EG0021 affected6 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA (14.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected4 at risk
EG0020 affected6 at risk
EG003
Myocardial ischaemia
Cardiac disorders
MedDRA (14.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected4 at risk
EG0020 affected6 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA (14.0)
Systematic Assessment
EG0000 affected6 at risk
EG0012 affected4 at risk
EG0020 affected6 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA (14.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA (14.0)
Systematic Assessment
EG0002 affected6 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Contrast media reaction
Injury, poisoning and procedural complications
MedDRA (14.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Excoriation
Injury, poisoning and procedural complications
MedDRA (14.0)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Hyperthyroidism
Endocrine disorders
MedDRA (14.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA (14.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA (14.0)
Systematic Assessment
EG0001 affected6 at risk
EG0011 affected4 at risk
EG0020 affected6 at risk
EG003
Breast tenderness
Reproductive system and breast disorders
MedDRA (14.0)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected4 at risk
EG0020 affected6 at risk
EG003
Erectile dysfunction
Reproductive system and breast disorders
MedDRA (14.0)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Upon investigator submission of a publication or presentation to Celgene, Celgene shall complete its review within 60 days after receipt of the proposed publication or presentation. Upon Celgene's request, proposed publication or presentation will be delayed up to 60 additional days to enable Celgene to secure adequate intellectual property protection of property of Celgene that would be affected by such proposed publication or presentation.
Point of Contact
Title
Organization
Phone
Extension
Email
Associate Director, Clinical Trial Disclosure
Celgene
1-888-260-1599
clinicaltrialdisclosure@celgene.com
ID
Term
D018288
Carcinoma, Small Cell
Ancestor Terms
ID
Term
D002277
Carcinoma
D009375
Neoplasms, Glandular and Epithelial
D009370
Neoplasms by Histologic Type
D009369
Neoplasms
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C467566
pomalidomide
D002945
Cisplatin
D005047
Etoposide
C061400
etoposide phosphate
Ancestor Terms
ID
Term
D017606
Chlorine Compounds
D007287
Inorganic Chemicals
D017672
Nitrogen Compounds
D017671
Platinum Compounds
D011034
Podophyllotoxin
D013764
Tetrahydronaphthalenes
D009281
Naphthalenes
D011084
Polycyclic Aromatic Hydrocarbons
D006841
Hydrocarbons, Aromatic
D006844
Hydrocarbons, Cyclic
D006838
Hydrocarbons
D009930
Organic Chemicals
D011083
Polycyclic Compounds
D005960
Glucosides
D006027
Glycosides
D002241
Carbohydrates
Browse Leaves
Not provided
Browse Branches
Not provided
0
OG002
Pomalidomide 4 mg
Oral pomalidomide 4 mg QD for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m^2 and etoposide 100 mg/m^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
OG003
Pomalidomide 5 mg
Oral pomalidomide 5 mg QD for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m^2 and etoposide 100 mg/m^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
Units
Counts
Participants
OG0006
OG0014
OG0026
OG0036
Title
Denominators
Categories
Title
Measurements
OG0001
OG0010
OG0020
OG0032
OG001
Pomalidomide 3 mg
Oral pomalidomide 3 mg QD for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m^2 and etoposide 100 mg/m^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
OG002
Pomalidomide 4 mg
Oral pomalidomide 4 mg QD for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m^2 and etoposide 100 mg/m^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
OG003
Pomalidomide 5 mg
Oral pomalidomide 5 mg QD for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m^2 and etoposide 100 mg/m^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
OG004
Pomalidomide (Overall, MTD Phase)
Participants received daily oral pomalidomide 1 mg to 5 mg for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m^2 and etoposide 100 mg/m^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
Units
Counts
Participants
OG0006
OG0014
OG0026
OG0036
OG00422
Title
Denominators
Categories
Complete Response
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
Partial Response
Title
Measurements
OG0003
OG0013
OG0022
OG003
No Change/Stable Disease
Title
Measurements
OG0000
OG0010
OG0020
OG003
Progressive Disease
Title
Measurements
OG0001
OG0011
OG0021
OG003
Not Assessed
Title
Measurements
OG0000
OG0010
OG0021
OG003
Missing
Title
Measurements
OG0002
OG0010
OG0022
OG003
Participants
OG00011
Title
Denominators
Categories
Title
Measurements
OG00013.2± 5.54
OG00022
Title
Denominators
Categories
Title
Measurements
OG00049.6(28.0 to 63.9)
OG001
Pomalidomide 3 mg
Participants received daily oral pomalidomide 3 mg for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m^2 and etoposide 100 mg/m^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
OG002
Pomalidomide 4 mg
Participants received daily oral pomalidomide 4 mg for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m^2 and etoposide 100 mg/m^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
OG003
Pomalidomide 5 mg
Participants received daily oral pomalidomide 5 mg for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m^2 and etoposide 100 mg/m^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
OG004
Pomalidomide (Overall, MTD Phase)
Participants received daily oral pomalidomide 1 mg to 5 mg for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m^2 and etoposide 100 mg/m^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
Units
Counts
Participants
OG0006
OG0014
OG0026
OG0036
OG00422
Title
Denominators
Categories
≥1 TEAE
Title
Measurements
OG0006
OG0014
OG0026
OG0036
OG00422
≥1 TEAE related to pomalidomide (POM)
Title
Measurements
OG0006
OG0014
OG0026
OG003
≥1 TEAE related to cisplatin and/or etoposide(C/E)
Title
Measurements
OG0006
OG0014
OG0026
OG003
≥1 Grade 3 or higher (GR3+) TEAE
Title
Measurements
OG0006
OG0014
OG0026
OG003
≥1 GR 3+ TEAE related to POM
Title
Measurements
OG0003
OG0012
OG0024
OG003
≥1 GR 3+ TEAE related to C/E
Title
Measurements
OG0006
OG0013
OG0026
OG003
≥1 Serious TEAE
Title
Measurements
OG0003
OG0011
OG0023
OG003
≥1 Serious TEAE related to POM
Title
Measurements
OG0002
OG0011
OG0021
OG003
≥1 Serious TEAE related to C/E
Title
Measurements
OG0002
OG0011
OG0023
OG003
≥1 TEAE leading to (→) withdrawal of POM
Title
Measurements
OG0002
OG0010
OG0022
OG003
≥1 TEAE → withdrawal of C/E
Title
Measurements
OG0002
OG0011
OG0021
OG003
≥1 TEAE → dose reduction/interruption of POM
Title
Measurements
OG0005
OG0012
OG0024
OG003
≥1 TEAE → dose reduction/interruption of C/E
Title
Measurements
OG0003
OG0013
OG0023
OG003
Units
Counts
Participants
OG00011
Title
Denominators
Categories
≥1 TEAE
Title
Measurements
OG0009
≥1 TEAE related to pomalidomide (POM)
Title
Measurements
OG0008
≥1 TEAE related to cisplatin and/or etoposide (C/E