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

Launched by NOVARTIS PHARMACEUTICALS · Nov 29, 2012

Keywords

ClinConnect Summary

This study was 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 were not eligible for or had disease progression after surgical or locoregional therapies, with c-MET dysregulation.

The study included a Dose-Determining Part and a Dose Expansion Part. Pharmacokinetic and safety profiles of INC280 in the setting of liver dysfunction were determined in the Dose-Determining Part. The Dose Expansion Part started when the appropriate dose for patient...

Gender

ALL

Eligibility 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.
• 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.