ARQ 197 in Combination With Chemotherapy in Patients With Metastatic Colorectal Cancer
Summary
ARQ 197 or placebo in combination with irinotecan and cetuximab in participants with metastatic colorectal cancer (CRC), in participants with wild-type KRAS alleles who have failed front-line systemic therapy, to evaluate the safety, tolerability, and efficacy of ARQ 197, define the recommended dose for Phase 2. After the recommended dose is determined for Phase 2, participants receive study drug or placebo with irinotecan and cetuximab.
Timeline
- Start
- 2010-01-26
- Primary completion
- 2012-10-12
- Completion
- 2015-02-20
Outcome
Missed primary endpoint
registry analysis (superiority test); Phase 2: Placebo+Cetuximab+Irinotecan vs Phase 2: ARQ 197+Cetuximab+Irinotecan; p = 0.3815; Log Rank NCT01075048 ↗
registry analysis (superiority test); Phase 2: Placebo+Cetuximab+Irinotecan vs Phase 2: ARQ 197+Cetuximab+Irinotecan; p = 0.4488; Log Rank NCT01075048 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tivantinib | Small molecule | 120 mg | — |
| Background | Cetuximab | Monoclonal antibody | 500 mg/m2 | Intravenous |
| Background | Irinotecan | Small molecule | 180 mg/m2 | Intravenous |