NCT00537511|TerminatedPhase 1/2Results
Study Stopped
This study was terminated for administrative reasons.
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This study was terminated for administrative reasons.
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
Sponsor study identifier
interventional
22
2 countries
6
Study Start
February 1, 2008
Actual (reported)Primary Completion
November 1, 2010
Actual (reported)Study Completion
December 1, 2010
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 1, 2010
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 27, 2007
Actual (reported)October 1, 2007
Actual (reported)February 1, 2008
Actual (reported)November 1, 2010
Actual (reported)December 1, 2010
Actual (reported)April 17, 2013
Actual (reported)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.)
Cycle 1 (21 days)
Number of Participants With Dose Limiting Toxicities (DLTs) During the MTD Phase
Cycles 1 - 6 (21-day cycles)
Tumor Response Rate According to Response Evaluation Criteria in Solid Tumors (RECIST)
Cycles 1 -6 (21-day cycles)
Duration of Response
From first Partial Response (PR) or Complete Response (CR) to disease progression (maximum of 19.4 weeks)
Overall Survival
From enrollment through study termination (approximately 35 months)
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).
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.
Ireland Cancer Center, Case Western Reserve University, Division of Hematology/Oncology
Cleveland, Ohio, 44106, United States
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
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.
Ulf Jungnelius, MD
Celgene Corporation
22 participants (actual enrollment reported by the registry).
First Submitted
September 27, 2007
First Posted
October 1, 2007
Study Start
February 1, 2008
Actual (reported)Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
November 1, 2010
Actual (reported)Study Completion
December 1, 2010
Actual (reported)Last Updated
November 19, 2019
Results First Posted
April 17, 2013
Record last verified: 2019-11
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Source: ClinicalTrials.gov.
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