All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.
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.
Advanced Hepatocellular Carcinoma With c-MET Dysregulation
Active, not recruiting
Feb 27, 2020
Mar 25, 2013
Sep 27, 2020
18 Years and older (Adult, Older Adult)
INC280 will be administered orally and continuously on a twice a day dosing schedule.
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.
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.