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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Participants With Dose Limiting Toxicities (DLTs) During the First Treatment Cycle of the Safety Lead-In Period

Outcome Description:

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.

Outcome Time Frame:

Up to Day 28 (Cycle 1)

Safety Issue:

Yes

Principal Investigator

Eric Van Cutsem, M.D., Ph,D

Investigator Role:

Principal Investigator

Investigator Affiliation:

Universitaire Ziekenhuis Gasthuisberg K.U. Leuven, Belgium

Authority:

Australia: Department of Health and Ageing Therapeutic Goods Administration

Study ID:

CC-5013-COLO-001

NCT ID:

NCT01032291

Start Date:

December 2009

Completion Date:

January 2011

Related Keywords:

  • Colorectal Cancer
  • Colorectal cancer
  • Revlimid
  • Lenalidomide
  • Cetuximab
  • Erbitux
  • KRAS
  • Colorectal Neoplasms

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