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

Withdrawn before enrolling · Phase 2 · Has a placebo group

Conditions studied: Advanced Hepatocellular Carcinoma

In brief

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).

Key facts

Study ID

NCT01964235

Run by

Novartis Pharmaceuticals

People needed

0

Starts

2016-12-01

Expected to finish

2019-07-01

Last updated by the study team

2016-09-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Confirmed c-MET pathway dysregulation.- Hepatocellular carcinoma stage B or C according to the Barcelona Clinic Liver cancer staging classification. - Current cirrhotic status of Child-Pugh class A with no encephalopathy. - Documented disease progression during or after discontinuation of sorafenib treatment or intolerance to sorafenib treatment. - Measurable disease as determined by RECIST v1.1. - ECOG performance status ≤ 1

You may not qualify if…

• Previous local antineoplastic therapy or investigational drug completed less than 5 half-lives of the agent prior to randomization and have not recovered from clinically significant toxicity from such treatment to grade ≤1 by the NCI-CTCAE. - Received any targeted therapy other than sorafenib.
• Active bleeding within 28 days prior to screening visit including variceal bleeding (esophageal varices should be treated according to standard practice and procedure completed 28 days prior to screening visit). - Clinically significant venous or arterial thrombotic disease within past 6 months.

Where it is running

• Massachusetts General Hospital Mass General Hospital — Boston, Massachusetts, United States
• Research Medical Center Onc Dept — Kansas City, Missouri, United States
• Novartis Investigative Site — Kogarah, New South Wales, Australia
• Novartis Investigative Site — Heidelberg, Victoria, Australia
• Novartis Investigative Site — Clichy, France
• Novartis Investigative Site — Lille, France
• Novartis Investigative Site — Montpellier, France
• Novartis Investigative Site — Nice, France
• Novartis Investigative Site — Essen, Germany
• Novartis Investigative Site — Würzburg, Germany
• Novartis Investigative Site — Hong Kong, Hong Kong
• Novartis Investigative Site — Hong Kong SAR, Hong Kong
• Novartis Investigative Site — Córdoba, Andalusia, Spain
• Novartis Investigative Site — Bern, Switzerland
• Novartis Investigative Site — Geneva, Switzerland

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.