Phase I study of ARQ 197 in HCC
Phase 1
- Conditions
- advanced HCC
- Registration Number
- JPRN-jRCT2080221860
- Lead Sponsor
- Kyowa Hakko Kirin Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 24
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety<br>Dose escalation to evaluate the tolerable dose of ARQ 197, CTCAE ver 4.0
- Secondary Outcome Measures
Name Time Method Pharmacokinetics profiles<br>Antitumor activity<br>Measurement of plasma concentration, RECIST 1.1