Neoplasms Clinical Trial
Official title:
A Phase 1b/2, Multi-center, Uncontrolled, Open-label, Dose Escalation Study of Refametinib (BAY86-9766) in Combination With Regorafenib (BAY73-4506) in Patients With Advanced or Metastatic Cancer
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.
Number of treatment-emergent Adverse Events (AEs) will be reported in Adverse Events section.
Study was originally designed with both Phase I and Phase II part, but sponsor decided not to
conduct Phase 2 part due to strategic portfolio re-prioritization.
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