Unresectable Hepatocellular Carcinoma Clinical Trial
Official title:
A Randomized Controlled Phase 2 Trial of ARQ 197 in Patients With Unresectable Hepatocellular Carcinoma (HCC) Who Have Failed One Prior Systemic Therapy
This is a global randomized, placebo-controlled, double-blinded Phase 2 study designed to compare treatment of ARQ 197 versus placebo in patients with unresectable HCC who had radiographic disease progression after systemic first line therapy or were unable to tolerate the therapy.
Patients will be randomly assigned in a 2:1 ratio to receive ARQ 197 or placebo. The
treatment assignment will be stratified based on Eastern Cooperative Oncology Group (ECOG)
performance status (PS), and vascular invasion status. The treatment with ARQ 197 or placebo
will be continued until progression of disease, unacceptable toxicity, or another
discontinuation criterion listed in this protocol is met.
After radiographic disease progression is documented, treatment assignment will be
unblinded. Patients who were assigned to placebo arm and had documented radiographic disease
progression will have the option to receive ARQ 197 and will be evaluated for objective
response rate and disease control rate continuously.
The study will continue until 78 total time to progression events are reached. At the end of
study, all remaining patients still on treatment will have the option to be rolled over to
another study to continue their treatment.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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