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
Sponsor
Celgene (Industry)
Overall Status
Terminated
CT.gov ID
NCT00537511
Collaborator
(none)
22
6
1
34
3.7
0.1
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1/Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
22 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date
:
Feb 1, 2008
Actual Primary Completion Date
:
Nov 1, 2010
Actual Study Completion Date
:
Dec 1, 2010
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Dose-finding arm: Pomalidomide + Cisplatin + Etoposide 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. |
Drug: Pomalidomide
Other Names:
Drug: Cisplatin
Other Names:
Drug: Etoposide
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Maximum Tolerated Dose (MTD) [Cycle 1 (21 days)]
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.)
Secondary Outcome Measures
- Number of Participants With Dose Limiting Toxicities (DLTs) During the MTD Phase [Cycles 1 - 6 (21-day cycles)]
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.
- Tumor Response Rate According to Response Evaluation Criteria in Solid Tumors (RECIST) [Cycles 1 -6 (21-day cycles)]
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.
- Duration of Response [From first Partial Response (PR) or Complete Response (CR) to disease progression (maximum of 19.4 weeks)]
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.
- Overall Survival [From enrollment through study termination (approximately 35 months)]
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.
- Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the MTD (Combination Treatment) Phase [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).]
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.
- Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Recovery Period or Maintenance (Monotherapy) Phase [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).]
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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ireland Cancer Center, Case Western Reserve University, Division of Hematology/Oncology | Cleveland | Ohio | United States | 44106 |
| 2 | Pennsylvania State University | Hershey | Pennsylvania | United States | 17033 |
| 3 | University of Texas Southwestern Medical Center | Dallas | Texas | United States | 75390 |
| 4 | Juranvinski Cancer Center - Medical Oncology | Hamilton | Ontario | Canada | L8V 5C2 |
| 5 | Princess Margaret Hospital | Toronto | Ontario | Canada | M5G 2M9 |
| 6 | Mc Gill University - Department of Oncology - Clinical Research Program | Montreal | Quebec | Canada | H2W 1S6 |
Sponsors and Collaborators
- Celgene
Investigators
- Study Director: Ulf Jungnelius, MD, Celgene Corporation
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Celgene
ClinicalTrials.gov Identifier:
NCT00537511
Other Study ID Numbers:
- CC-4047-SCLC-002
First Posted:
Oct 1, 2007
Last Update Posted:
Nov 19, 2019
Last Verified:
Nov 1, 2019
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Pomalidomide (Overall) |
|---|---|
| Arm/Group Description | 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. |
| Period Title: Treatment Period (Combination) | |
| STARTED | 22 |
| Intent-to-Treat (ITT) Populaton | 22 |
| Safety Population | 22 |
| COMPLETED | 17 |
| NOT COMPLETED | 5 |
| Period Title: Treatment Period (Combination) | |
| STARTED | 17 |
| COMPLETED | 11 |
| NOT COMPLETED | 6 |
| Period Title: Treatment Period (Combination) | |
| STARTED | 11 |
| COMPLETED | 3 |
| NOT COMPLETED | 8 |
| Period Title: Treatment Period (Combination) | |
| STARTED | 8 |
| COMPLETED | 0 |
| NOT COMPLETED | 8 |
Baseline Characteristics
| Arm/Group Title | Pomalidomide (Overall) |
|---|---|
| Arm/Group Description | 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. |
| Overall Participants | 22 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
63.9
(8.76)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
4
18.2%
|
| Male |
18
81.8%
|
| Race/Ethnicity, Customized (participants) [Number] | |
| Caucasian (White) |
22
100%
|
| Non-caucasian |
0
0%
|
Outcome Measures
| Title | Maximum Tolerated Dose (MTD) |
|---|---|
| Description | 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.) |
| Time Frame | Cycle 1 (21 days) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population |
| Arm/Group Title | Pomalidomide (Overall) |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 22 |
| Number [mg] |
4
|
| Title | Number of Participants With Dose Limiting Toxicities (DLTs) During the MTD Phase |
|---|---|
| Description | 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. |
| Time Frame | Cycles 1 - 6 (21-day cycles) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population |
| Arm/Group Title | Pomalidomide 1 mg | Pomalidomide 3 mg | Pomalidomide 4 mg | Pomalidomide 5 mg |
|---|---|---|---|---|
| Arm/Group Description | 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). | 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). | 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). | 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). |
| Measure Participants | 6 | 4 | 6 | 6 |
| Number [participants] |
1
4.5%
|
0
NaN
|
0
NaN
|
2
NaN
|
| Title | Tumor Response Rate According to Response Evaluation Criteria in Solid Tumors (RECIST) |
|---|---|
| Description | 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. |
| Time Frame | Cycles 1 -6 (21-day cycles) |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Pomalidomide 1 mg | Pomalidomide 3 mg | Pomalidomide 4 mg | Pomalidomide 5 mg | Pomalidomide (Overall, MTD Phase) |
|---|---|---|---|---|---|
| Arm/Group Description | 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). | 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). | 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). | 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). | 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). |
| Measure Participants | 6 | 4 | 6 | 6 | 22 |
| Complete Response |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
| Partial Response |
3
13.6%
|
3
NaN
|
2
NaN
|
3
NaN
|
11
NaN
|
| No Change/Stable Disease |
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
| Progressive Disease |
1
4.5%
|
1
NaN
|
1
NaN
|
1
NaN
|
4
NaN
|
| Not Assessed |
0
0%
|
0
NaN
|
1
NaN
|
0
NaN
|
1
NaN
|
| Missing |
2
9.1%
|
0
NaN
|
2
NaN
|
2
NaN
|
6
NaN
|
| Title | Duration of Response |
|---|---|
| Description | 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. |
| Time Frame | From first Partial Response (PR) or Complete Response (CR) to disease progression (maximum of 19.4 weeks) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of participants in ITT population who were considered Responders. |
| Arm/Group Title | Pomalidomide (Overall) |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 11 |
| Mean (Standard Deviation) [weeks] |
13.2
(5.54)
|
| Title | Overall Survival |
|---|---|
| Description | 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. |
| Time Frame | From enrollment through study termination (approximately 35 months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants in the ITT population. |
| Arm/Group Title | Pomalidomide (Overall) |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 22 |
| Median (95% Confidence Interval) [weeks] |
49.6
|
| Title | Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the MTD (Combination Treatment) Phase |
|---|---|
| Description | 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. |
| Time Frame | 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). |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population |
| Arm/Group Title | Pomalidomide 1 mg | Pomalidomide 3 mg | Pomalidomide 4 mg | Pomalidomide 5 mg | Pomalidomide (Overall, MTD Phase) |
|---|---|---|---|---|---|
| Arm/Group Description | 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). | 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). | 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). | 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). | 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). |
| Measure Participants | 6 | 4 | 6 | 6 | 22 |
| ≥1 TEAE |
6
27.3%
|
4
NaN
|
6
NaN
|
6
NaN
|
22
NaN
|
| ≥1 TEAE related to pomalidomide (POM) |
6
27.3%
|
4
NaN
|
6
NaN
|
6
NaN
|
22
NaN
|
| ≥1 TEAE related to cisplatin and/or etoposide(C/E) |
6
27.3%
|
4
NaN
|
6
NaN
|
6
NaN
|
22
NaN
|
| ≥1 Grade 3 or higher (GR3+) TEAE |
6
27.3%
|
4
NaN
|
6
NaN
|
6
NaN
|
22
NaN
|
| ≥1 GR 3+ TEAE related to POM |
3
13.6%
|
2
NaN
|
4
NaN
|
5
NaN
|
14
NaN
|
| ≥1 GR 3+ TEAE related to C/E |
6
27.3%
|
3
NaN
|
6
NaN
|
5
NaN
|
20
NaN
|
| ≥1 Serious TEAE |
3
13.6%
|
1
NaN
|
3
NaN
|
3
NaN
|
10
NaN
|
| ≥1 Serious TEAE related to POM |
2
9.1%
|
1
NaN
|
1
NaN
|
3
NaN
|
7
NaN
|
| ≥1 Serious TEAE related to C/E |
2
9.1%
|
1
NaN
|
3
NaN
|
3
NaN
|
9
NaN
|
| ≥1 TEAE leading to (→) withdrawal of POM |
2
9.1%
|
0
NaN
|
2
NaN
|
2
NaN
|
6
NaN
|
| ≥1 TEAE → withdrawal of C/E |
2
9.1%
|
1
NaN
|
1
NaN
|
2
NaN
|
6
NaN
|
| ≥1 TEAE → dose reduction/interruption of POM |
5
22.7%
|
2
NaN
|
4
NaN
|
4
NaN
|
15
NaN
|
| ≥1 TEAE → dose reduction/interruption of C/E |
3
13.6%
|
3
NaN
|
3
NaN
|
4
NaN
|
13
NaN
|
| Title | Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Recovery Period or Maintenance (Monotherapy) Phase |
|---|---|
| Description | 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. |
| Time Frame | 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). |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population; participants continuing in the Recovery Period and Maintenance Phase. |
| Arm/Group Title | Pomalidomide (Overall) |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 11 |
| ≥1 TEAE |
9
40.9%
|
| ≥1 TEAE related to pomalidomide (POM) |
8
36.4%
|
| ≥1 TEAE related to cisplatin and/or etoposide (C/E |
7
31.8%
|
| ≥1 Grade 3 or higher (GR3+) TEAE |
6
27.3%
|
| ≥1 GR 3+ TEAE related to POM |
2
9.1%
|
| ≥1 GR 3+ TEAE related to C/E |
2
9.1%
|
| ≥1 TEAE → dose reduction/interruption of POM |
2
9.1%
|
Adverse Events
| 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. | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting 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). | |||||||||
| Arm/Group Title | Pomalidomide 1 mg | Pomalidomide 3 mg | Pomalidomide 4 mg | Pomalidomide 5 mg | Pomalidomide (Overall) | |||||
| Arm/Group Description | 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). | 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). | 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). | 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). | 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. | |||||
All Cause Mortality |
||||||||||
| Pomalidomide 1 mg | Pomalidomide 3 mg | Pomalidomide 4 mg | Pomalidomide 5 mg | Pomalidomide (Overall) | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | |||||
Serious Adverse Events |
||||||||||
| Pomalidomide 1 mg | Pomalidomide 3 mg | Pomalidomide 4 mg | Pomalidomide 5 mg | Pomalidomide (Overall) | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 3/6 (50%) | 1/4 (25%) | 3/6 (50%) | 3/6 (50%) | 10/22 (45.5%) | |||||
| Blood and lymphatic system disorders | ||||||||||
| Febrile Neutropenia | 0/6 (0%) | 1/4 (25%) | 0/6 (0%) | 1/6 (16.7%) | 2/22 (9.1%) | |||||
| Cardiac disorders | ||||||||||
| Atrioventricular Block Complete | 0/6 (0%) | 0/4 (0%) | 0/6 (0%) | 1/6 (16.7%) | 1/22 (4.5%) | |||||
| Gastrointestinal disorders | ||||||||||
| Diverticular Perforation | 0/6 (0%) | 0/4 (0%) | 0/6 (0%) | 1/6 (16.7%) | 1/22 (4.5%) | |||||
| General disorders | ||||||||||
| Fatigue | 1/6 (16.7%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 1/22 (4.5%) | |||||
| Infections and infestations | ||||||||||
| Neutropenic Infection | 1/6 (16.7%) | 0/4 (0%) | 0/6 (0%) | 1/6 (16.7%) | 2/22 (9.1%) | |||||
| Sepsis | 1/6 (16.7%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 1/22 (4.5%) | |||||
| Investigations | ||||||||||
| Blood Creatinine Increased | 0/6 (0%) | 0/4 (0%) | 1/6 (16.7%) | 0/6 (0%) | 1/22 (4.5%) | |||||
| Metabolism and nutrition disorders | ||||||||||
| Hypoglycaemia | 1/6 (16.7%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 1/22 (4.5%) | |||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||
| Breast Cancer | 1/6 (16.7%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 1/22 (4.5%) | |||||
| Nervous system disorders | ||||||||||
| Cerebral Ischaemia | 1/6 (16.7%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 1/22 (4.5%) | |||||
| Convulsion | 1/6 (16.7%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 1/22 (4.5%) | |||||
| Transient Ischaemic Attack | 0/6 (0%) | 0/4 (0%) | 0/6 (0%) | 1/6 (16.7%) | 1/22 (4.5%) | |||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||
| Pulmonary Embolism | 0/6 (0%) | 0/4 (0%) | 2/6 (33.3%) | 0/6 (0%) | 2/22 (9.1%) | |||||
Other (Not Including Serious) Adverse Events |
||||||||||
| Pomalidomide 1 mg | Pomalidomide 3 mg | Pomalidomide 4 mg | Pomalidomide 5 mg | Pomalidomide (Overall) | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 6/6 (100%) | 4/4 (100%) | 6/6 (100%) | 6/6 (100%) | 22/22 (100%) | |||||
| Blood and lymphatic system disorders | ||||||||||
| Neutropenia | 3/6 (50%) | 2/4 (50%) | 3/6 (50%) | 5/6 (83.3%) | 13/22 (59.1%) | |||||
| Thrombocytopenia | 1/6 (16.7%) | 2/4 (50%) | 0/6 (0%) | 2/6 (33.3%) | 5/22 (22.7%) | |||||
| Anaemia | 1/6 (16.7%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 1/22 (4.5%) | |||||
| Leukopenia | 0/6 (0%) | 0/4 (0%) | 1/6 (16.7%) | 0/6 (0%) | 1/22 (4.5%) | |||||
| Pancytopenia | 0/6 (0%) | 0/4 (0%) | 0/6 (0%) | 1/6 (16.7%) | 1/22 (4.5%) | |||||
| Cardiac disorders | ||||||||||
| Atrial fibrillation | 0/6 (0%) | 0/4 (0%) | 1/6 (16.7%) | 2/6 (33.3%) | 3/22 (13.6%) | |||||
| Angina pectoris | 0/6 (0%) | 1/4 (25%) | 0/6 (0%) | 0/6 (0%) | 1/22 (4.5%) | |||||
| Myocardial ischaemia | 0/6 (0%) | 1/4 (25%) | 0/6 (0%) | 0/6 (0%) | 1/22 (4.5%) | |||||
| Ear and labyrinth disorders | ||||||||||
| Tinnitus | 0/6 (0%) | 2/4 (50%) | 0/6 (0%) | 1/6 (16.7%) | 3/22 (13.6%) | |||||
| Ear pain | 0/6 (0%) | 0/4 (0%) | 0/6 (0%) | 1/6 (16.7%) | 1/22 (4.5%) | |||||
| Endocrine disorders | ||||||||||
| Hyperthyroidism | 0/6 (0%) | 0/4 (0%) | 0/6 (0%) | 1/6 (16.7%) | 1/22 (4.5%) | |||||
| Hypothyroidism | 0/6 (0%) | 0/4 (0%) | 0/6 (0%) | 1/6 (16.7%) | 1/22 (4.5%) | |||||
| Eye disorders | ||||||||||
| Lacrimation increased | 1/6 (16.7%) | 1/4 (25%) | 0/6 (0%) | 0/6 (0%) | 2/22 (9.1%) | |||||
| Vision blurred | 0/6 (0%) | 0/4 (0%) | 1/6 (16.7%) | 1/6 (16.7%) | 2/22 (9.1%) | |||||
| Cataract | 1/6 (16.7%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 1/22 (4.5%) | |||||
| Diplopia | 0/6 (0%) | 0/4 (0%) | 0/6 (0%) | 1/6 (16.7%) | 1/22 (4.5%) | |||||
| Dry eye | 0/6 (0%) | 0/4 (0%) | 1/6 (16.7%) | 0/6 (0%) | 1/22 (4.5%) | |||||
| Eye pain | 0/6 (0%) | 0/4 (0%) | 0/6 (0%) | 1/6 (16.7%) | 1/22 (4.5%) | |||||
| Gastrointestinal disorders | ||||||||||
| Nausea | 3/6 (50%) | 2/4 (50%) | 5/6 (83.3%) | 5/6 (83.3%) | 15/22 (68.2%) | |||||
| Constipation | 3/6 (50%) | 2/4 (50%) | 4/6 (66.7%) | 4/6 (66.7%) | 13/22 (59.1%) | |||||
| Diarrhoea | 3/6 (50%) | 0/4 (0%) | 1/6 (16.7%) | 2/6 (33.3%) | 6/22 (27.3%) | |||||
| Dyspepsia | 2/6 (33.3%) | 0/4 (0%) | 2/6 (33.3%) | 2/6 (33.3%) | 6/22 (27.3%) | |||||
| Vomiting | 1/6 (16.7%) | 0/4 (0%) | 2/6 (33.3%) | 3/6 (50%) | 6/22 (27.3%) | |||||
| Abdominal pain | 1/6 (16.7%) | 1/4 (25%) | 0/6 (0%) | 2/6 (33.3%) | 4/22 (18.2%) | |||||
| Abdominal distension | 0/6 (0%) | 0/4 (0%) | 1/6 (16.7%) | 0/6 (0%) | 1/22 (4.5%) | |||||
| Dental discomfort | 0/6 (0%) | 0/4 (0%) | 1/6 (16.7%) | 0/6 (0%) | 1/22 (4.5%) | |||||
| Dysphagia | 0/6 (0%) | 0/4 (0%) | 1/6 (16.7%) | 0/6 (0%) | 1/22 (4.5%) | |||||
| Flatulence | 1/6 (16.7%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 1/22 (4.5%) | |||||
| Haemorrhoids | 0/6 (0%) | 0/4 (0%) | 0/6 (0%) | 1/6 (16.7%) | 1/22 (4.5%) | |||||
| Ileus | 0/6 (0%) | 0/4 (0%) | 0/6 (0%) | 1/6 (16.7%) | 1/22 (4.5%) | |||||
| Rectal haemorrhage | 0/6 (0%) | 0/4 (0%) | 0/6 (0%) | 1/6 (16.7%) | 1/22 (4.5%) | |||||
| Tooth loss | 0/6 (0%) | 1/4 (25%) | 0/6 (0%) | 0/6 (0%) | 1/22 (4.5%) | |||||
| General disorders | ||||||||||
| Fatigue | 5/6 (83.3%) | 4/4 (100%) | 6/6 (100%) | 6/6 (100%) | 21/22 (95.5%) | |||||
| Oedema peripheral | 2/6 (33.3%) | 1/4 (25%) | 3/6 (50%) | 3/6 (50%) | 9/22 (40.9%) | |||||
| Asthenia | 1/6 (16.7%) | 1/4 (25%) | 0/6 (0%) | 1/6 (16.7%) | 3/22 (13.6%) | |||||
| Chest discomfort | 1/6 (16.7%) | 0/4 (0%) | 1/6 (16.7%) | 1/6 (16.7%) | 3/22 (13.6%) | |||||
| Chest pain | 0/6 (0%) | 0/4 (0%) | 2/6 (33.3%) | 1/6 (16.7%) | 3/22 (13.6%) | |||||
| Pyrexia | 1/6 (16.7%) | 0/4 (0%) | 1/6 (16.7%) | 1/6 (16.7%) | 3/22 (13.6%) | |||||
| Chills | 0/6 (0%) | 0/4 (0%) | 1/6 (16.7%) | 1/6 (16.7%) | 2/22 (9.1%) | |||||
| Irritability | 1/6 (16.7%) | 0/4 (0%) | 0/6 (0%) | 1/6 (16.7%) | 2/22 (9.1%) | |||||
| Face oedema | 0/6 (0%) | 0/4 (0%) | 0/6 (0%) | 1/6 (16.7%) | 1/22 (4.5%) | |||||
| Facial pain | 0/6 (0%) | 0/4 (0%) | 1/6 (16.7%) | 0/6 (0%) | 1/22 (4.5%) | |||||
| Infusion site reaction | 0/6 (0%) | 0/4 (0%) | 0/6 (0%) | 1/6 (16.7%) | 1/22 (4.5%) | |||||
| Injection site reaction | 0/6 (0%) | 0/4 (0%) | 1/6 (16.7%) | 0/6 (0%) | 1/22 (4.5%) | |||||
| Mucosal inflammation | 1/6 (16.7%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 1/22 (4.5%) | |||||
| Immune system disorders | ||||||||||
| Hypersensitivity | 1/6 (16.7%) | 1/4 (25%) | 0/6 (0%) | 0/6 (0%) | 2/22 (9.1%) | |||||
| Infections and infestations | ||||||||||
| Rhinitis | 1/6 (16.7%) | 0/4 (0%) | 0/6 (0%) | 3/6 (50%) | 4/22 (18.2%) | |||||
| Nasopharyngitis | 0/6 (0%) | 0/4 (0%) | 1/6 (16.7%) | 1/6 (16.7%) | 2/22 (9.1%) | |||||
| Oral candidiasis | 0/6 (0%) | 1/4 (25%) | 1/6 (16.7%) | 0/6 (0%) | 2/22 (9.1%) | |||||
| Pneumonia | 0/6 (0%) | 0/4 (0%) | 2/6 (33.3%) | 0/6 (0%) | 2/22 (9.1%) | |||||
| Sinusitis | 1/6 (16.7%) | 1/4 (25%) | 0/6 (0%) | 0/6 (0%) | 2/22 (9.1%) | |||||
| Cellulitis | 0/6 (0%) | 1/4 (25%) | 0/6 (0%) | 0/6 (0%) | 1/22 (4.5%) | |||||
| Infected cyst | 0/6 (0%) | 0/4 (0%) | 1/6 (16.7%) | 0/6 (0%) | 1/22 (4.5%) | |||||
| Influenza | 0/6 (0%) | 0/4 (0%) | 0/6 (0%) | 1/6 (16.7%) | 1/22 (4.5%) | |||||
| Laryngitis | 0/6 (0%) | 0/4 (0%) | 1/6 (16.7%) | 0/6 (0%) | 1/22 (4.5%) | |||||
| Lobar pneumonia | 0/6 (0%) | 0/4 (0%) | 0/6 (0%) | 1/6 (16.7%) | 1/22 (4.5%) | |||||
| Mastoiditis | 1/6 (16.7%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 1/22 (4.5%) | |||||
| Respiratory tract infection | 0/6 (0%) | 1/4 (25%) | 0/6 (0%) | 0/6 (0%) | 1/22 (4.5%) | |||||
| Skin infection | 0/6 (0%) | 0/4 (0%) | 1/6 (16.7%) | 0/6 (0%) | 1/22 (4.5%) | |||||
| Upper respiratory tract infection | 0/6 (0%) | 0/4 (0%) | 0/6 (0%) | 1/6 (16.7%) | 1/22 (4.5%) | |||||
| Urinary tract infection | 0/6 (0%) | 1/4 (25%) | 0/6 (0%) | 0/6 (0%) | 1/22 (4.5%) | |||||
| Injury, poisoning and procedural complications | ||||||||||
| Contusion | 2/6 (33.3%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 2/22 (9.1%) | |||||
| Contrast media reaction | 0/6 (0%) | 0/4 (0%) | 0/6 (0%) | 1/6 (16.7%) | 1/22 (4.5%) | |||||
| Excoriation | 1/6 (16.7%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 1/22 (4.5%) | |||||
| Investigations | ||||||||||
| Haemoglobin decreased | 2/6 (33.3%) | 2/4 (50%) | 2/6 (33.3%) | 3/6 (50%) | 9/22 (40.9%) | |||||
| Weight decreased | 0/6 (0%) | 2/4 (50%) | 0/6 (0%) | 1/6 (16.7%) | 3/22 (13.6%) | |||||
| Blood creatinine increased | 1/6 (16.7%) | 1/4 (25%) | 0/6 (0%) | 0/6 (0%) | 2/22 (9.1%) | |||||
| Platelet count decreased | 0/6 (0%) | 1/4 (25%) | 0/6 (0%) | 1/6 (16.7%) | 2/22 (9.1%) | |||||
| Blood magnesium decreased | 0/6 (0%) | 0/4 (0%) | 0/6 (0%) | 1/6 (16.7%) | 1/22 (4.5%) | |||||
| Blood potassium decreased | 0/6 (0%) | 1/4 (25%) | 0/6 (0%) | 0/6 (0%) | 1/22 (4.5%) | |||||
| Creatinine renal clearance decreased | 0/6 (0%) | 0/4 (0%) | 1/6 (16.7%) | 0/6 (0%) | 1/22 (4.5%) | |||||
| Electrocardiogram qt prolonged | 0/6 (0%) | 1/4 (25%) | 0/6 (0%) | 0/6 (0%) | 1/22 (4.5%) | |||||
| Electrocardiogram st-t segment abnormal | 1/6 (16.7%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 1/22 (4.5%) | |||||
| Weight increased | 1/6 (16.7%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 1/22 (4.5%) | |||||
| Metabolism and nutrition disorders | ||||||||||
| Decreased appetite | 2/6 (33.3%) | 2/4 (50%) | 4/6 (66.7%) | 0/6 (0%) | 8/22 (36.4%) | |||||
| Dehydration | 1/6 (16.7%) | 0/4 (0%) | 1/6 (16.7%) | 2/6 (33.3%) | 4/22 (18.2%) | |||||
| Diabetes mellitus | 0/6 (0%) | 0/4 (0%) | 1/6 (16.7%) | 1/6 (16.7%) | 2/22 (9.1%) | |||||
| Hypoalbuminaemia | 0/6 (0%) | 0/4 (0%) | 0/6 (0%) | 2/6 (33.3%) | 2/22 (9.1%) | |||||
| Hypocalcaemia | 0/6 (0%) | 0/4 (0%) | 0/6 (0%) | 2/6 (33.3%) | 2/22 (9.1%) | |||||
| Hypokalaemia | 0/6 (0%) | 0/4 (0%) | 0/6 (0%) | 2/6 (33.3%) | 2/22 (9.1%) | |||||
| Hypomagnesaemia | 0/6 (0%) | 0/4 (0%) | 0/6 (0%) | 2/6 (33.3%) | 2/22 (9.1%) | |||||
| Hyponatraemia | 1/6 (16.7%) | 0/4 (0%) | 0/6 (0%) | 1/6 (16.7%) | 2/22 (9.1%) | |||||
| Hypophosphataemia | 0/6 (0%) | 0/4 (0%) | 0/6 (0%) | 2/6 (33.3%) | 2/22 (9.1%) | |||||
| Gout | 0/6 (0%) | 0/4 (0%) | 0/6 (0%) | 1/6 (16.7%) | 1/22 (4.5%) | |||||
| Hyperkalaemia | 1/6 (16.7%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 1/22 (4.5%) | |||||
| Musculoskeletal and connective tissue disorders | ||||||||||
| Musculoskeletal chest pain | 2/6 (33.3%) | 2/4 (50%) | 1/6 (16.7%) | 1/6 (16.7%) | 6/22 (27.3%) | |||||
| Muscular weakness | 1/6 (16.7%) | 2/4 (50%) | 0/6 (0%) | 1/6 (16.7%) | 4/22 (18.2%) | |||||
| Arthralgia | 1/6 (16.7%) | 2/4 (50%) | 0/6 (0%) | 0/6 (0%) | 3/22 (13.6%) | |||||
| Back pain | 1/6 (16.7%) | 0/4 (0%) | 0/6 (0%) | 1/6 (16.7%) | 2/22 (9.1%) | |||||
| Myalgia | 0/6 (0%) | 1/4 (25%) | 0/6 (0%) | 1/6 (16.7%) | 2/22 (9.1%) | |||||
| Neck pain | 1/6 (16.7%) | 1/4 (25%) | 0/6 (0%) | 0/6 (0%) | 2/22 (9.1%) | |||||
| Pain in extremity | 1/6 (16.7%) | 0/4 (0%) | 1/6 (16.7%) | 0/6 (0%) | 2/22 (9.1%) | |||||
| Arthritis | 0/6 (0%) | 0/4 (0%) | 1/6 (16.7%) | 0/6 (0%) | 1/22 (4.5%) | |||||
| Muscle spasms | 0/6 (0%) | 1/4 (25%) | 0/6 (0%) | 0/6 (0%) | 1/22 (4.5%) | |||||
| Musculoskeletal pain | 0/6 (0%) | 1/4 (25%) | 0/6 (0%) | 0/6 (0%) | 1/22 (4.5%) | |||||
| Osteoarthritis | 0/6 (0%) | 1/4 (25%) | 0/6 (0%) | 0/6 (0%) | 1/22 (4.5%) | |||||
| Pain in jaw | 0/6 (0%) | 1/4 (25%) | 0/6 (0%) | 0/6 (0%) | 1/22 (4.5%) | |||||
| Nervous system disorders | ||||||||||
| Peripheral sensory neuropathy | 2/6 (33.3%) | 3/4 (75%) | 2/6 (33.3%) | 2/6 (33.3%) | 9/22 (40.9%) | |||||
| Dizziness | 3/6 (50%) | 0/4 (0%) | 1/6 (16.7%) | 2/6 (33.3%) | 6/22 (27.3%) | |||||
| Dysgeusia | 2/6 (33.3%) | 2/4 (50%) | 2/6 (33.3%) | 0/6 (0%) | 6/22 (27.3%) | |||||
| Headache | 0/6 (0%) | 0/4 (0%) | 4/6 (66.7%) | 0/6 (0%) | 4/22 (18.2%) | |||||
| Tremor | 2/6 (33.3%) | 0/4 (0%) | 1/6 (16.7%) | 0/6 (0%) | 3/22 (13.6%) | |||||
| Memory impairment | 1/6 (16.7%) | 1/4 (25%) | 0/6 (0%) | 0/6 (0%) | 2/22 (9.1%) | |||||
| Apraxia | 0/6 (0%) | 0/4 (0%) | 0/6 (0%) | 1/6 (16.7%) | 1/22 (4.5%) | |||||
| Ataxia | 1/6 (16.7%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 1/22 (4.5%) | |||||
| Convulsion | 0/6 (0%) | 0/4 (0%) | 1/6 (16.7%) | 0/6 (0%) | 1/22 (4.5%) | |||||
| Hypoaesthesia | 0/6 (0%) | 0/4 (0%) | 0/6 (0%) | 1/6 (16.7%) | 1/22 (4.5%) | |||||
| Lethargy | 1/6 (16.7%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 1/22 (4.5%) | |||||
| Speech disorder | 1/6 (16.7%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 1/22 (4.5%) | |||||
| Syncope | 0/6 (0%) | 0/4 (0%) | 0/6 (0%) | 1/6 (16.7%) | 1/22 (4.5%) | |||||
| Psychiatric disorders | ||||||||||
| Depression | 1/6 (16.7%) | 1/4 (25%) | 1/6 (16.7%) | 1/6 (16.7%) | 4/22 (18.2%) | |||||
| Insomnia | 1/6 (16.7%) | 1/4 (25%) | 0/6 (0%) | 2/6 (33.3%) | 4/22 (18.2%) | |||||
| Anxiety | 0/6 (0%) | 0/4 (0%) | 1/6 (16.7%) | 0/6 (0%) | 1/22 (4.5%) | |||||
| Confusional state | 0/6 (0%) | 0/4 (0%) | 0/6 (0%) | 1/6 (16.7%) | 1/22 (4.5%) | |||||
| Personality change | 0/6 (0%) | 0/4 (0%) | 0/6 (0%) | 1/6 (16.7%) | 1/22 (4.5%) | |||||
| Renal and urinary disorders | ||||||||||
| Nocturia | 0/6 (0%) | 0/4 (0%) | 1/6 (16.7%) | 1/6 (16.7%) | 2/22 (9.1%) | |||||
| Urinary incontinence | 1/6 (16.7%) | 1/4 (25%) | 0/6 (0%) | 0/6 (0%) | 2/22 (9.1%) | |||||
| Pollakiuria | 0/6 (0%) | 1/4 (25%) | 0/6 (0%) | 0/6 (0%) | 1/22 (4.5%) | |||||
| Reproductive system and breast disorders | ||||||||||
| Breast tenderness | 0/6 (0%) | 1/4 (25%) | 0/6 (0%) | 0/6 (0%) | 1/22 (4.5%) | |||||
| Erectile dysfunction | 0/6 (0%) | 0/4 (0%) | 0/6 (0%) | 1/6 (16.7%) | 1/22 (4.5%) | |||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||
| Dyspnoea | 2/6 (33.3%) | 1/4 (25%) | 4/6 (66.7%) | 2/6 (33.3%) | 9/22 (40.9%) | |||||
| Cough | 1/6 (16.7%) | 2/4 (50%) | 0/6 (0%) | 1/6 (16.7%) | 4/22 (18.2%) | |||||
| Haemoptysis | 0/6 (0%) | 1/4 (25%) | 1/6 (16.7%) | 1/6 (16.7%) | 3/22 (13.6%) | |||||
| Dysphonia | 1/6 (16.7%) | 1/4 (25%) | 0/6 (0%) | 0/6 (0%) | 2/22 (9.1%) | |||||
| Epistaxis | 0/6 (0%) | 1/4 (25%) | 0/6 (0%) | 1/6 (16.7%) | 2/22 (9.1%) | |||||
| Oropharyngeal pain | 0/6 (0%) | 0/4 (0%) | 0/6 (0%) | 2/6 (33.3%) | 2/22 (9.1%) | |||||
| Allergic sinusitis | 1/6 (16.7%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 1/22 (4.5%) | |||||
| Hiccups | 0/6 (0%) | 1/4 (25%) | 0/6 (0%) | 0/6 (0%) | 1/22 (4.5%) | |||||
| Hypoxia | 0/6 (0%) | 0/4 (0%) | 1/6 (16.7%) | 0/6 (0%) | 1/22 (4.5%) | |||||
| Pleural effusion | 0/6 (0%) | 0/4 (0%) | 0/6 (0%) | 1/6 (16.7%) | 1/22 (4.5%) | |||||
| Pleurisy | 0/6 (0%) | 0/4 (0%) | 0/6 (0%) | 1/6 (16.7%) | 1/22 (4.5%) | |||||
| Rhinitis allergic | 0/6 (0%) | 0/4 (0%) | 1/6 (16.7%) | 0/6 (0%) | 1/22 (4.5%) | |||||
| Rhinorrhoea | 1/6 (16.7%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 1/22 (4.5%) | |||||
| Skin and subcutaneous tissue disorders | ||||||||||
| Alopecia | 3/6 (50%) | 3/4 (75%) | 1/6 (16.7%) | 5/6 (83.3%) | 12/22 (54.5%) | |||||
| Rash | 1/6 (16.7%) | 1/4 (25%) | 3/6 (50%) | 2/6 (33.3%) | 7/22 (31.8%) | |||||
| Dry skin | 1/6 (16.7%) | 1/4 (25%) | 1/6 (16.7%) | 2/6 (33.3%) | 5/22 (22.7%) | |||||
| Pruritus | 0/6 (0%) | 0/4 (0%) | 2/6 (33.3%) | 1/6 (16.7%) | 3/22 (13.6%) | |||||
| Rash erythematous | 0/6 (0%) | 0/4 (0%) | 1/6 (16.7%) | 1/6 (16.7%) | 2/22 (9.1%) | |||||
| Skin lesion | 0/6 (0%) | 1/4 (25%) | 1/6 (16.7%) | 0/6 (0%) | 2/22 (9.1%) | |||||
| Dermal cyst | 1/6 (16.7%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 1/22 (4.5%) | |||||
| Hyperhidrosis | 0/6 (0%) | 0/4 (0%) | 0/6 (0%) | 1/6 (16.7%) | 1/22 (4.5%) | |||||
| Hypoaesthesia facial | 0/6 (0%) | 0/4 (0%) | 1/6 (16.7%) | 0/6 (0%) | 1/22 (4.5%) | |||||
| Petechiae | 1/6 (16.7%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 1/22 (4.5%) | |||||
| Rash pruritic | 1/6 (16.7%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 1/22 (4.5%) | |||||
| Vascular disorders | ||||||||||
| Hypotension | 1/6 (16.7%) | 0/4 (0%) | 1/6 (16.7%) | 3/6 (50%) | 5/22 (22.7%) | |||||
| Flushing | 1/6 (16.7%) | 1/4 (25%) | 0/6 (0%) | 1/6 (16.7%) | 3/22 (13.6%) | |||||
| Phlebitis | 0/6 (0%) | 0/4 (0%) | 1/6 (16.7%) | 0/6 (0%) | 1/22 (4.5%) | |||||
| Thrombophlebitis superficial | 0/6 (0%) | 1/4 (25%) | 0/6 (0%) | 0/6 (0%) | 1/22 (4.5%) | |||||
| Thrombosis | 0/6 (0%) | 1/4 (25%) | 0/6 (0%) | 0/6 (0%) | 1/22 (4.5%) | |||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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.
Results Point of Contact
| Name/Title | Associate Director, Clinical Trial Disclosure |
|---|---|
| Organization | Celgene |
| Phone | 1-888-260-1599 |
| clinicaltrialdisclosure@celgene.com |
Responsible Party:
Celgene
ClinicalTrials.gov Identifier:
NCT00537511
Other Study ID Numbers:
- CC-4047-SCLC-002
First Posted:
Oct 1, 2007
Last Update Posted:
Nov 19, 2019
Last Verified:
Nov 1, 2019