drugset / Trial / NCT01032291
A Study to Assess the Efficacy and Safety of Lenalidomide in Combination With Cetuximab in Pre-treated Patients With KRAS Mutant Colorectal Cancer
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2009-12
- Primary completion
- 2011-01
- Completion
- 2011-01
Outcome
Missed primary endpoint
Stopped (Business): “A business decision not to continue with Phase 2b based on non-safety observations during proof of concept phase.”
paper study enrollment was terminated prematurely due to lack of efficacy in both treatment arms and failure to achieve the planned response objective. PMID 24244261 ↗
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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cetuximab | Monoclonal antibody | 250 mg/m2 | Intravenous |
| Subject | Lenalidomide | Other / unclassified | 25 mg | Oral |