drugset / Trial / NCT01715441

Sorafenib in Combination With Irinotecan in Metastatic Colorectal Cancer Patients With KRAS Mutated Tumors

NCT01715441 ↗

Phase 2 Completed 173 enrolled Institut du Cancer de Montpellier - Val d'Aurelle
RandomizedCrossoverOpen-labelTreatment

Summary

The aim of this multicenter randomized phase II trial is to determine the efficacy of sorafenib and irinotecan combination versus irinotecan monotherapy or versus sorafenib monotherapy in metastatic colorectal cancer patients with KRAS mutated tumors after failure of all active drugs known to be effective.

Timeline

Start
2012-09
Primary completion
2015-03
Completion
2015-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Irinotecan Small molecule 120 mg/m2 Intravenous
Subject Irinotecan Small molecule 150 mg/m2 Intravenous
Subject Irinotecan Small molecule 180 mg/m2 Intravenous
Subject Sorafenib Small molecule 400 mg Oral

Indications