NCT01915589

Refametinib(BAY86-9766) in RAS Mutant Hepatocellular Carcinoma (HCC)

A Prospective, Single-arm, Multicenter, Uncontrolled, Open-label Phase II Trial of Refametinib (BAY86-9766) in Patients With RAS Mutant Hepatocellular Carcinoma (HCC)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a study to investigate the potential clinical benefit of refametinib in patients with unresectable or metastatic HCC carrying a RAS mutation. The study will be conducted in 2 stages. Approximately 95 patients (15 at Stage 1/ 80 at Stage 2) will be accrued to this study to receive treatment. Stage 2 of the trial will only be conducted if at least 5 out of 15 patients at Stage 1 show at least confirmed partial response (PR) according to modified response evaluation criteria in solid tumors (mRECIST) assessed by central image review. Refametinib is an oral (i.e. taken by mouth) protein kinase inhibitor. A kinase inhibitor targets certain key proteins that are essential for the survival of the cancer cell. By specifically targeting these proteins, refametinib may stop cancer growth. The growth of the tumor may be decreased by preventing these specific proteins from functioning. The primary endpoint (the most meaningful result to be tracked) of this study is based on the rate of response, i.e. the disease getting smaller. The aim is to show that the therapy with refametinib improves the response rate in this RAS mutation patient population.

Conditions

• Carcinoma, Hepatocellular

Interventions

Type	Name	Description
DRUG	Refametinib (BAY86-9766)	All patients who meet the entry criteria will receive refametinib 50 mg (2x20 mg + 1x10 mg capsules or 50 mg tablet) bid.

Timeline

• Start date: 2013-09-16
• Primary completion: 2014-10-08
• Completion: 2014-10-08
• First posted: 2013-08-05
• Last updated: 2021-04-08

Locations

58 sites across 17 countries: United States, Austria, Belgium, Czechia, France, Germany, Hong Kong, Hungary, Italy, Japan, New Zealand, South Korea, Spain, Switzerland, Taiwan, Thailand, United Kingdom