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

• Status: Active, not recruiting
• Trial end date: 2022-02-11
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals

Criteria

Inclusion Criteria:

• Confirmed c-MET pathway dysregulation.

• Advanced hepatocellular carcinoma which could not be suitable for treatment with locoregional therapies or has progressed following locoregional therapy.

• Measurable disease as determined by RECIST version 1.1.

• Current cirrhotic status of Child-Pugh class A with no encephalopathy.

• Eastern Cooperative Oncology Group (ECOG) performance status < or = 2.

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Received any prior systemic chemotherapy or molecular-targeted therapy for hepatocellular carcinoma such as sorafenib.

• Previous treatment with c-MET inhibitor or hepatocyte growth factor targeting therapy.

• Previous local therapy completed less than 4 weeks prior to dosing and, if present, any acute toxicity > grade 1.

• Known active bleeding (e.g. bleeding from gastro-intestinal ulcers or esophageal varices) within 2 months prior to screening or with history or evidence of inherited bleeding diathesis or coagulopathy.

• Clinically significant venous or arterial thrombotic disease within past 6 months.

• History of acute or chronic pancreatitis, surgery of pancreas or any risk factors that may increase risk of pancreatitis.

• Other protocol-defined exclusion criteria may apply.