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A Phase II, Open Label, Single Arm, Multicenter Study of INC280 Administered Orally in Adults With Advanced Hepatocellular Carcinoma

Phase 2
18 Years
Open (Enrolling)
Advanced Hepatocellular Carcinoma With c-MET Dysregulation

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Trial Information

A Phase II, Open Label, Single Arm, Multicenter Study of INC280 Administered Orally in Adults With Advanced Hepatocellular Carcinoma

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

The study includes a Dose-Determining Part and a Dose Expansion Part. Pharmacokinetic and
safety profiles of INC280 in the setting of liver dysfunction will be determined in the
Dose-Determining Part. The Dose Expansion Part will start when the appropriate dose for
patients with liver dysfunction is determined based on pharmacokinetics (PK) and safety data
from the Dose-Determining Part and other INC280 ongoing clinical studies.

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

- 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.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Description:

Time to progression is the time from the date of baseline evaluation to the date of the first documented radiological confirmation of disease progression or death due to underlying cancer.

Outcome Time Frame:

baseline, 6 weeks up to 6 months

Safety Issue:


Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals


China: Food and Drug Administration

Study ID:




Start Date:

March 2013

Completion Date:

November 2015

Related Keywords:

  • Advanced Hepatocellular Carcinoma With c-MET Dysregulation
  • INC280, advanced hepatocellular carcinoma, c-MET pathway dysregulation
  • Carcinoma
  • Carcinoma, Hepatocellular