drugset / Trial / NCT02168777

Refametinib (BAY86-9766) in Combination With Regorafenib (Stivarga, BAY73-4506) in Patients With Advanced or Metastatic Cancer

NCT02168777

Phase 1 Terminated 20 enrolled Bayer
Non-randomizedParallel-groupOpen-labelTreatment

Summary

Phase I: Determine the maximum tolerated dose of combination of Regorafenib with Refametinib through a dose escalation study, all tumor types that meet certain inclusion/exclusion criteria can be entered. After the recommended dose is determined, the Phase II portion of the study will evaluate tolerability and efficacy of the combination treatment in patients with breast cancer, lung cancer, or colorectal cancer, respectively.

Timeline

Start
2014-06-23
Primary completion
2015-10-23
Completion
2016-04-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Refametinib Small molecule 20 mg
Subject Refametinib Small molecule 30 mg
Subject Regorafenib Small molecule 80 mg
Subject Regorafenib Small molecule 120 mg

Indications