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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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 or death due to underlying cancer.
baseline, 6 weeks up to 6 months
China: Food and Drug Administration