Spots Global Cancer Trial Database for Study Efficacy and Safety of INC280 in Patients With Advanced Hepatocellular Carcinoma.

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Trial Identification

Brief Title: Study Efficacy and Safety of INC280 in Patients With Advanced Hepatocellular Carcinoma.

Official Title: A Phase II, Open Label, Single Arm, Multicenter Study of INC280 Administered Orally in Adults With Advanced Hepatocellular Carcinoma

Study ID: NCT01737827

Conditions

Advanced Hepatocellular Carcinoma With c-MET Dysregulation

Interventions

INC280

Study Description

Brief Summary: This study is to find out if INC280 is safe and has beneficial effects in patients with advanced hepatocellular carcinoma known to have dysregulation of c-MET pathway.

Detailed Description: This study is designed as a Phase II, single arm, open-label, multicenter study to evaluate the safety and efficacy of INC280 as first-line treatment in patients with advanced hepatocellular carcinoma (HCC) who are not eligible for or had disease progression after surgical or locoregional therapies, with c- MET dysregulation. The study includes a Dose-Determining Part and a Dose Expansion Part. Pharmacokinetic and safety profiles of INC280 in the setting of liver dysfunction will be determined in the Dose-Determining Part. The Dose Expansion Part will start when the appropriate dose for patients with liver dysfunction is determined based on pharmacokinetics (PK) and safety data from the Dose-Determining Part and other INC280 ongoing clinical studies.