JPRN-jRCT2080221860UnknownPhase 1
Phase I study of ARQ 197 in advanced hepatocellular carcinoma
Kyowa Hakko Kirin Co., Ltd.0 sites24 target enrollmentStarted: July 20, 2012Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Sponsor
- Enrollment
- 24
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- >= 20age old to ot applicable (—)
- Sex
- All
Inclusion Criteria
- •Major 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
- •Major 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
Investigators
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Safety Study of ARQ 197 in Cirrhotic Patients With Hepatocellular Carcinoma (HCC)Hepatocellular CarcinomaCirrhosisNCT00802555ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)21
