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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01032291
Registration number
NCT01032291
Ethics application status
Date submitted
14/12/2009
Date registered
15/12/2009
Date last updated
21/05/2013
Titles & IDs
Public title
A Study to Assess the Efficacy and Safety of Lenalidomide in Combination With Cetuximab in Pre-treated Patients With KRAS Mutant Colorectal Cancer
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Scientific title
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
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Secondary ID [1]
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2009-012665-61
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Secondary ID [2]
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CC-5013-COLO-001
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Colorectal Cancer
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Condition category
Condition code
Cancer
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Bowel - Back passage (rectum) or large bowel (colon)
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - cetuximab
Treatment: Drugs - lenalidomide
Experimental: lenalidomide plus cetuximab - Combination therapy of lenalidomide plus cetuximab
Experimental: lenalidomide - Single agent therapy of lenalidomide
Treatment: Drugs: 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.
Treatment: Drugs: lenalidomide
Daily oral lenalidomide 25mg on days 1 to 28 of each 28 day cycle
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Participants With Dose Limiting Toxicities (DLTs) During the First Treatment Cycle of the Safety Lead-In Period
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Assessment method [1]
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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.
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Timepoint [1]
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Up to Day 28 (Cycle 1)
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Primary outcome [2]
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Percentage of Participants With a Response to Treatment During the Proof of Concept Period
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Assessment method [2]
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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.
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Timepoint [2]
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week 9 up to week 24
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Secondary outcome [1]
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Kaplan-Meier Estimates for Progression Free Survival (PFS)
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Assessment method [1]
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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.
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Timepoint [1]
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up to week 24
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Secondary outcome [2]
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Kaplan-Meier Estimates for Duration of Response
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Assessment method [2]
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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.
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Timepoint [2]
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up to week 24
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Secondary outcome [3]
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Percentage of Participants With Disease Control
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Assessment method [3]
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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.
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Timepoint [3]
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up to week 24
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Secondary outcome [4]
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Kaplan-Meier Estimates for Overall Survival
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Assessment method [4]
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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.
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Timepoint [4]
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up to 5.5 years
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Secondary outcome [5]
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Participants With Treatment-Emergent Adverse Events (TEAE)
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Assessment method [5]
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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.
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Timepoint [5]
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up to week 28
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/12/2009
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/01/2011
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Sample size
Target
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Accrual to date
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Final
51
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Recruitment in Australia
Recruitment state(s)
SA
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Recruitment hospital [1]
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Flinders Medical Centre, Dept. of Oncology - Bedford Park
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Recruitment postcode(s) [1]
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- Bedford Park
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Recruitment outside Australia
Country [1]
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Belgium
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State/province [1]
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Antwerp
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Belgium
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State/province [2]
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Brussels
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Belgium
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Charleroi
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Belgium
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State/province [4]
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Gent
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Country [5]
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Belgium
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State/province [5]
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Leuven
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Country [6]
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Belgium
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State/province [6]
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Liège
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Country [7]
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Germany
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State/province [7]
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Niedersachsen
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Italy
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Ancona
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Italy
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Genova
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Italy
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Milano
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Spain
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State/province [11]
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Barcelona
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Spain
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State/province [12]
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Santander
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Spain
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State/province [13]
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Valencia
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Country [14]
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Sweden
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State/province [14]
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Gothenburg
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Country [15]
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Sweden
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State/province [15]
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Stockholm
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Country [16]
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Sweden
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State/province [16]
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Uppsala
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Celgene Corporation
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01032291
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Eric Van Cutsem, M.D., Ph,D
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Address
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Universitaire Ziekenhuis Gasthuisberg K.U. Leuven, Belgium
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01032291
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