An Open-Label Phase-1 Study of OPB-31121 in Patients With Advanced Solid Tumors
Phase 1
- Conditions
- Solid Tumor
- Registration Number
- NCT00657176
- Lead Sponsor
- Korea Otsuka Pharmaceutical Co., Ltd.
- Brief Summary
This is an open-label, non-randomized, single-center, dose-escalation study in patients with advanced solid tumors. Six dose levels (100, 200, 400, 600, 800, and 1000 mg/day) are planned for the study. In this study, OPB-31121's potential for toxic effects will be evaluated in patients with advanced solid tumors to evaluate the recommended dose for use in subsequent studies. The pharmacokinetics and antitumor effect of the compound will also be investigated.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 36
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Maximum tolerated dose Cycle 1
- Secondary Outcome Measures
Name Time Method Safety and dose-limiting toxicity Duration of Study Pharmacokinetics Cycle 1 Antitumor effect Duration of study
Trial Locations
- Locations (1)
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of