Phase 1 Multiple Ascending Dose Study of BMS-754807 in Patients With Solid Tumors in Japan
Phase 1
20 Years
N/A
20 Years
N/A
Not Enrolling
Both
Neoplasms
Both
Neoplasms
Trial Information
Phase 1 Multiple Ascending Dose Study of BMS-754807 in Patients With Solid Tumors in Japan
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To determine the Maximum Tolerated Dose of BMS-754807 based on the Dose Limited Toxicity which observed during the first 28 days
Outcome Time Frame:
Within the first 28 days
Safety Issue:
Yes
Principal Investigator
Bristol-Myers Squibb
Investigator Role:
Study Director
Investigator Affiliation:
Bristol-Myers Squibb
Authority:
Japan: Pharmaceuticals and Medical Devices Agency
Study ID:
CA191-003
NCT ID:
NCT00898716
Start Date:
September 2009
Completion Date:
July 2011
Related Keywords:
- Neoplasms
- Neoplasms
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