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

Phase 2WithdrawnNCT01964235

Novartis Pharmaceuticals

Overview

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).

Study was cancelled by Sponsor prior to enrollment of patients.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Conditions

Advanced Hepatocellular Carcinoma

Interventions

INC280DRUG

INC280 will be administered orally and continuously on a twice a day dosing schedule.

PlaceboDRUG

Placebo will be administered orally and continuously on a twice a day dosing schedule.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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.

Locations (15)

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

Outcomes

Primary Outcomes

Time to progression using Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1

Time to progression is the time from the date of baseline evaluation to the date of the first documented radiological confirmation of disease progression.

Time frame: baseline, 6 weeks up to 6 months

Secondary Outcomes

Best Overall Response

Best overall response is defined as the best response recorded from the date of randomization until the date of last tumor assessment per RECIST version 1.1.

Time frame: date of treatment, every 6 weeks up to 6 months

Overall Response Rate

Overall Response Rate is defined as the proportion of patients with a best overall response of complete response or partial response at any time on study per RECIST version 1.1.

Time frame: baseline, every 6 weeks up to 6 months

Disease Control Rate

Disease control rate is defined as the proportion of patients with a best overall response of complete response, partial response or stable disease at any time on study per RECIST version 1.1.

Time frame: baseline, every 6 weeks up to 6 months

Progression Free Survival

Progression free survival is defined as the time from date of randomization to the date of the first radiologically documented progression or death due to any cause. If a patient has not experienced radiologically documented progression or death, progression free survival is censored at the date of last adequate tumor assessment.

Time frame: randomization, every 6 weeks up to 6 months

Overall Survival

Overall survival is defined as the time from date of randomization to the date of death due to any cause. If a patient is not known to have died, survival will be censored at the date of last contact.

Data from ClinicalTrials.gov

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