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A Study to Assess the Efficacy and Safety of Lenalidomide in Combination With Cetuximab in Pre-treated Patients With KRAS Mutant Colorectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01032291
Recruitment Status : Terminated (A business decision not to continue with Phase 2b based on non-safety observations during proof of concept phase.)
First Posted : December 15, 2009
Results First Posted : May 21, 2013
Last Update Posted : May 21, 2013
Sponsor:
Information provided by (Responsible Party):
Celgene ( Celgene Corporation )

Tracking Information
First Submitted Date  ICMJE December 14, 2009
First Posted Date  ICMJE December 15, 2009
Results First Submitted Date  ICMJE April 1, 2013
Results First Posted Date  ICMJE May 21, 2013
Last Update Posted Date May 21, 2013
Study Start Date  ICMJE December 2009
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 1, 2013)
  • Participants With Dose Limiting Toxicities (DLTs) During the First Treatment Cycle of the Safety Lead-In Period [ Time Frame: Up to Day 28 (Cycle 1) ]
    The number of participants with DLTs determines the maximum tolerated dose of the combination therapy used in the Proof of Concept (POC) period: If <2 of the initial 6 participants experience a DLT, then the POC will start with lenalidomide at 25 mg. If ≥2 of the initial 6 participants experienced a DLT, then 6 more subjects were to be enrolled at 20 mg lenalidomide. If <2 of the additional 6 subjects experienced a DLT, then the lenalidomide starting dose for the POC was to be 20 mg. If ≥2 of the additional 6 subjects experienced a DLT, then 6 more subjects were to be enrolled at 15 mg lenalidomide. If <2 of the additional 6 subjects experienced a DLT, then the POC was to start with lenalidomide at 15 mg. If ≥2 of the additional 6 subjects experienced a DLT, the dosing for the study was to be reassessed by Celgene Corporation and the investigators.
  • Percentage of Participants With a Response to Treatment During the Proof of Concept Period [ Time Frame: week 9 up to week 24 ]
    Tumor response was evaluated every 2 cycles beginning with Cycle 3 Day 1 and at treatment discontinuation. Response and progression were evaluated using the RECIST 1.1 criteria (Eisenhauer, 2009). Treatment response includes both complete response and partial response.
    • Complete response-disappearance of all lesions
    • Partial response-30% decrease in the sum of diameters of target lesions from baseline
    Analysis was not performed due to the early termination of the study.
Original Primary Outcome Measures  ICMJE
 (submitted: December 14, 2009)
  • Phase 2a: Maximum Tolerated Dose (MTD) [ Time Frame: Within 28 days of treatment induction ]
  • Phase 2b: Tumor Response Rate (RECIST 1.1) [ Time Frame: After at least 2 cycles of treatment have been completed ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 1, 2013)
  • Kaplan-Meier Estimates for Progression Free Survival (PFS) [ Time Frame: up to week 24 ]
    PFS was calculated as the time from randomization to the earlier of the first documentation of progressive disease (PD), or death on study due to any cause. Analysis was not performed due to the early termination of the study.
  • Kaplan-Meier Estimates for Duration of Response [ Time Frame: up to week 24 ]
    Duration of response was defined as the time from the initial response date to progressive disease (PD) for participants who achieved an objective confirmed complete response (CR) or partial response (PR). Analysis was not performed due to the early termination of the study.
  • Percentage of Participants With Disease Control [ Time Frame: up to week 24 ]
    Known as the Disease Control Rate (DCR), participants with a complete response, partial response or stable disease contribute to the DCR. This analysis was not performed due to the early termination of the study.
  • Kaplan-Meier Estimates for Overall Survival [ Time Frame: up to 5.5 years ]
    Overall survival was defined as the time between randomization and death. It was intended that participants would be followed for up to 5 years following discontinuation from treatment. Analysis was not performed due to the early termination of the study.
  • Participants With Treatment-Emergent Adverse Events (TEAE) [ Time Frame: up to week 28 ]
    TEAEs are any adverse event occurring or worsening on or after the first treatment of any study drug and within 28 days after the last dose of the last study drug received. Relation to study drug was determined by the investigator. Severity of AE is graded according to National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.0. Severity is a 5-point scale: 3= severe or medically significant but not life-threatening 4=life-threatening, urgent intervention required 5=death related to AE.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 14, 2009)
  • Safety (type, frequency, and severity of adverse events (AEs) and relationship of AEs to study drug) [ Time Frame: Once informed consent is signed until 28 days after last dose ]
  • Progression Free Survival (PFS) [ Time Frame: From start of therapy to progression using RECIST 1.1, death, or discontinuation ]
  • Duration of response [ Time Frame: Length of time from response per RECIST 1.1 until progression, death, or discontinuation ]
  • Overall survival (OS) [ Time Frame: Length of time from start of therapy until death, lost to follow up, or 5 years after treatment discontinuation ]
  • Disease Control Rate (DCR) [ Time Frame: From start of therapy to treatment discontinuation ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Assess the Efficacy and Safety of Lenalidomide in Combination With Cetuximab in Pre-treated Patients With KRAS Mutant Colorectal Cancer
Official Title  ICMJE A Phase 2, Open-Label Study To Evaluate The Efficacy And Safety Of Lenalidomide In Combination With Cetuximab In Pretreated Subjects With K-Ras Mutant Metastatic Colorectal Cancer
Brief Summary The purpose of this study is to determine whether lenalidomide in combination with cetuximab is safe and effective in patients with KRAS mutant colorectal cancer.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Colorectal Cancer
Intervention  ICMJE
  • Drug: cetuximab
    Intravenous infusions of cetuximab (400 mg/m^2 Cycle 1 Day 1, thereafter 250 mg/m^2), administered on days 1, 8, 15 and 22 of each 28 day cycle.
    Other Name: Erbitux
  • Drug: lenalidomide
    Daily oral lenalidomide 25mg on days 1 to 28 of each 28 day cycle
    Other Name: Revlimid
Study Arms  ICMJE
  • Experimental: lenalidomide plus cetuximab
    Combination therapy of lenalidomide plus cetuximab
    Interventions:
    • Drug: cetuximab
    • Drug: lenalidomide
  • Experimental: lenalidomide
    Single agent therapy of lenalidomide
    Intervention: Drug: lenalidomide
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: August 10, 2010)
51
Original Estimated Enrollment  ICMJE
 (submitted: December 14, 2009)
220
Actual Study Completion Date  ICMJE January 2011
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Metastatic colorectal adenocarcinoma.
  2. Confirmed K-RAS mutant tumor
  3. Disease progression on oxaliplatin- AND irinotecan-containing regimens, with at least one of these regimens containing bevacizumab.
  4. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1.

Exclusion Criteria:

  1. Use of chemotherapy, hormonal therapy, immunotherapy or any other cancer or experimental treatment ≤ 28 days prior to the first day of the first cycle.
  2. Radiotherapy for up to ≥ 30% of the bone marrow.
  3. Surgery ≤ 28 days before day 1 of the first cycle (minimally invasive interventions for diagnostic purposes or disease staging are permitted).
  4. Previous treatment with cetuximab, panitumumab, pomalidomide (CC-4047), lenalidomide or thalidomide.
  5. Untreated, symptomatic brain metastases (brain imaging not required).
  6. Venous thromboembolism ≤ 6 months before day1 of the first cycle.
  7. Current congestive heart failure (classes II to IV of the New York Heart Association).
  8. Myocardial infarction ≤ 12 months before day1 of the first cycle.
  9. Uncontrolled hypertension.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Belgium,   Germany,   Italy,   Spain,   Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01032291
Other Study ID Numbers  ICMJE CC-5013-COLO-001
2009-012665-61 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Celgene ( Celgene Corporation )
Study Sponsor  ICMJE Celgene Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Eric Van Cutsem, M.D., Ph,D Universitaire Ziekenhuis Gasthuisberg K.U. Leuven, Belgium
Principal Investigator: Josep Tabernero, M.D. Hospital Vall d´Hebrón, Servicio de Oncología, Barcelona. Spain
PRS Account Celgene
Verification Date April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP