Phase I Study of ARQ 197 in Advanced Hepatocellular Carcinoma
Phase 1
20 Years
N/A
20 Years
N/A
Open (Enrolling)
Both
Advanced Hepatocellular Carcinoma
Both
Advanced Hepatocellular Carcinoma
Trial Information
Phase I Study of ARQ 197 in Advanced Hepatocellular Carcinoma
Inclusion Criteria:
- Confirmed HCC patients who are resistant to, intolerable to, or rejecting a systemic
sorafenib therapy
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Child-Pugh classification A at the time of registration
- Adequate bone marrow, liver, and renal functions within 14 days prior to registration
Exclusion Criteria:
- Prior therapy with a c-Met inhibitor (including ARQ 197)
- Any systemic anti-tumor treatment or investigational agent within 2 weeks prior to
registration. If the treatment/agent was antibody, within 4 weeks
- Local treatment for malignancy within 4 weeks prior to registration
- Major surgical procedure within 4 weeks prior to registration
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Number of participants with dose-limiting toxicity (DLT), as a measure of safety and tolerability
Outcome Description:
Adverse Event collection and assessment will be done for all treated subjects to assess the safety, tolerability. The grading for the severity of the adverse events will be determined according to CTCAE ver 4.0.
Outcome Time Frame:
DLT observation period will be the first 28 days after the start of ARQ 197 treatment.
Safety Issue:
Yes
Authority:
Japan: Ministry of Health, Labor and Welfare
Study ID:
ARQ 197-008
NCT ID:
NCT01656265
Start Date:
July 2012
Completion Date:
Related Keywords:
- Advanced Hepatocellular Carcinoma
- Carcinoma
- Carcinoma, Hepatocellular
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