Multiple Ascending Dose Study of BMS-754807 in Patients With Solid Tumors in Japan
- Registration Number
- NCT00898716
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this clinical study is to establish the maximum tolerated dose of BMS-754807 when administered orally on a once daily schedule in subjects with solid tumors.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
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
Exclusion Criteria
- Any disorder with dysregulation of glucose homeostasis
- Dumping syndrome
- History of glucose intolerance
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description BMS-754807 BMS-754807 -
- Primary Outcome Measures
Name Time Method To determine the Maximum Tolerated Dose of BMS-754807 based on the Dose Limited Toxicity which observed during the first 28 days Within the first 28 days
- Secondary Outcome Measures
Name Time Method To assess the safety and tolerability Day 1, 8, 15, 22, 29, thereafter every 2 weeks To establish recommended Phase 2 dose of BMS-754807 when administered orally on a once daily schedule Day 1, 8, 15, 22, 29, thereafter every 2 weeks To assess the metabolic effect on blood glucose Day 1, 8, 15, 22, 29, thereafter every 2 weeks To assess the pharmacokinetics of BMS-754807 administered orally on a once daily schedule Day 1, 8, 15, 22, 29, thereafter every 2 weeks To assess any preliminary evidence of anti-tumor activity Day 1, 8, 15, 22, 29, thereafter every 2 weeks To explore potential biomarkers of biological response Day 1, 8, 15, 22, 29, thereafter every 2 weeks
Trial Locations
- Locations (1)
Local Institution
🇯🇵Chuo-Ku, Tokyo, Japan