Japanese Phase 1 Study of BMS-844203 (CT322)
Phase 1
Withdrawn
- Conditions
- Neoplasms
- Interventions
- Drug: BMS-844203 (CT-322)
- Registration Number
- NCT01146171
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this clinical study is to evaluate the safety and tolerability of CT-322 monotherapy to determine the recommended dose for phase II and subsequent studies
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Advanced or metastatic solid tumors for whom the standard of care is ineffective or inappropriate
- Life expectancy of at least 3 months
- Eastern Cooperative Oncology Group performance 0-1
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Exclusion Criteria
- Subject has uncontrolled diabetes or hypertension
- Clinical significant bleeding diathesis or coagulopathy
- Thrombotic or embolic cerebrovascular accident
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description BMS-844203 (CT-322) BMS-844203 (CT-322) -
- Primary Outcome Measures
Name Time Method Determine recommended dose for Phase 2 study of CT-322 Within the first 28 days
- Secondary Outcome Measures
Name Time Method To assess the plasma pharmacokinetics of CT-322. Pharmacokinetics of CT-322 will be derived from plasma concentration versus time data. The pharmacokinetic parameters to be assessed include Cmax, Cmin, Tmax, AUC (INF), AUC (TAU), T-HALF, etc. Cycle 2 and beyond (up to 6 cycle): Day 1 at each cycle and then every 3 cycles thereafter To assess anti-tumor activity of CT-322 Every 8 weeks To assess the effects of CT-322 on plasma VEGF levels Cycle 3: Day 1 To assess the presence of anti CT-322 antibodies Cycle 3 and beyond (up to 6 cycle): Day 1 at each cycle and then every 3 cycles thereafter
Trial Locations
- Locations (1)
Local Institution
🇯🇵Osaka-Sayama-Shi, Osaka, Japan