NCT01964235

Study of Efficacy and Safety INC280 in Patients With Advanced Hepatocellular Carcinoma

A Randomized Phase II, Double-blind, Placebo-controlled, Multi-center Study to Evaluate the Efficacy and Safety of INC280 in Adult Patients With Advanced Hepatocellular Carcinoma After Progression or Intolerance to Sorafenib Treatment

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is establish whether INC280 is safe and has beneficial effects in patients with advanced hepatocellular carcinoma known to have dysregulation of c-MET pathway and whose disease progressed while on, or after, treatment with sorafenib or who are intolerant to sorafenib. Patients will be randomized in a 2:1 ratio to receive INC280 at 600mg BID plus best supportive care (BSC) or placebo plus BSC, until disease progression or intolerable to study treatment. Patients treated with placebo plus BSC will have the opportunity to receive INC280 treatment upon documented further disease progression (RECIST 1.1) per investigator's discretion after unblinding. Patient will be stratified to geographical region (Asia vs Rest of World ) and tumor burden (present macroscopic vascular invasion and/or extra-hepatic spread vs not present).

Detailed description

Study was cancelled by Sponsor prior to enrollment of patients.

Conditions

• Advanced Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	INC280	INC280 will be administered orally and continuously on a twice a day dosing schedule.
DRUG	Placebo	Placebo will be administered orally and continuously on a twice a day dosing schedule.

Timeline

• Start date: 2016-12-01
• Primary completion: 2019-07-01
• Completion: 2019-07-01
• First posted: 2013-10-17
• Last updated: 2016-09-01

Locations

15 sites across 7 countries: United States, Australia, France, Germany, Hong Kong, Spain, Switzerland