Safety Study of ARQ 197 in Cirrhotic Patients With Hepatocellular Carcinoma (HCC)
NCT00802555 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21
Last updated 2012-07-12
Summary
Multi-center, single-arm Phase 1b study designed to evaluate safety and tolerability of ARQ 197 in cirrhotic patients with HCC.
Conditions
- Cirrhosis
- Hepatocellular Carcinoma
Interventions
- DRUG
-
ARQ 197
360 mg administered twice daily until disease progression, unacceptable toxicity, or other discontinuation criterion is met
Sponsors & Collaborators
-
ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-01-31
- Primary Completion
- 2011-12-31
- Completion
- 2011-12-31
Countries
- United States
- Italy
- Spain
Study Locations
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