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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Secondary ID [1] 0 0
2009-012665-61
Secondary ID [2] 0 0
CC-5013-COLO-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colorectal Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Participants With Dose Limiting Toxicities (DLTs) During the First Treatment Cycle of the Safety Lead-In Period
Timepoint [1] 0 0
Up to Day 28 (Cycle 1)
Primary outcome [2] 0 0
Percentage of Participants With a Response to Treatment During the Proof of Concept Period
Timepoint [2] 0 0
week 9 up to week 24
Secondary outcome [1] 0 0
Kaplan-Meier Estimates for Progression Free Survival (PFS)
Timepoint [1] 0 0
up to week 24
Secondary outcome [2] 0 0
Kaplan-Meier Estimates for Duration of Response
Timepoint [2] 0 0
up to week 24
Secondary outcome [3] 0 0
Percentage of Participants With Disease Control
Timepoint [3] 0 0
up to week 24
Secondary outcome [4] 0 0
Kaplan-Meier Estimates for Overall Survival
Timepoint [4] 0 0
up to 5.5 years
Secondary outcome [5] 0 0
Participants With Treatment-Emergent Adverse Events (TEAE)
Timepoint [5] 0 0
up to week 28

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2011
Sample size
Target
Accrual to date
Final
51
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Flinders Medical Centre, Dept. of Oncology - Bedford Park
Recruitment postcode(s) [1] 0 0
- Bedford Park
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Antwerp
Country [2] 0 0
Belgium
State/province [2] 0 0
Brussels
Country [3] 0 0
Belgium
State/province [3] 0 0
Charleroi
Country [4] 0 0
Belgium
State/province [4] 0 0
Gent
Country [5] 0 0
Belgium
State/province [5] 0 0
Leuven
Country [6] 0 0
Belgium
State/province [6] 0 0
Liège
Country [7] 0 0
Germany
State/province [7] 0 0
Niedersachsen
Country [8] 0 0
Italy
State/province [8] 0 0
Ancona
Country [9] 0 0
Italy
State/province [9] 0 0
Genova
Country [10] 0 0
Italy
State/province [10] 0 0
Milano
Country [11] 0 0
Spain
State/province [11] 0 0
Barcelona
Country [12] 0 0
Spain
State/province [12] 0 0
Santander
Country [13] 0 0
Spain
State/province [13] 0 0
Valencia
Country [14] 0 0
Sweden
State/province [14] 0 0
Gothenburg
Country [15] 0 0
Sweden
State/province [15] 0 0
Stockholm
Country [16] 0 0
Sweden
State/province [16] 0 0
Uppsala

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Celgene Corporation
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT01032291
Trial related presentations / publications
Gandhi AK, Shi T, Li M, Jungnelius U, Romano A, Tabernero J, Siena S, Schafer PH, Chopra R. Immunomodulatory effects in a phase II study of lenalidomide combined with cetuximab in refractory KRAS-mutant metastatic colorectal cancer patients. PLoS One. 2013 Nov 11;8(11):e80437. doi: 10.1371/journal.pone.0080437. eCollection 2013.
Siena S, Van Cutsem E, Li M, Jungnelius U, Romano A, Beck R, Bencardino K, Elez ME, Prenen H, Sanchis M, Sartore-Bianchi A, Tejpar S, Gandhi A, Shi T, Tabernero J. Phase II open-label study to assess efficacy and safety of lenalidomide in combination with cetuximab in KRAS-mutant metastatic colorectal cancer. PLoS One. 2013 Nov 11;8(11):e62264. doi: 10.1371/journal.pone.0062264. eCollection 2013.
Public notes

Contacts
Principal investigator
Name 0 0
Eric Van Cutsem, M.D., Ph,D
Address 0 0
Universitaire Ziekenhuis Gasthuisberg K.U. Leuven, Belgium
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01032291