Multiple Dose Study In Cancer Patients: Safety and Tolerability of BMS-754807 in Advanced or Metastatic Solid Tumors
- Registration Number
- NCT00569036
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
This is a Phase 1 dose escalation study to determine the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary anti-tumor activity of BMS-754807 in patients with advanced or metastatic solid tumors. In addition, the study is expected to identify the recommended dose or dose range of BMS-754807 for Phase 2 studies
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 63
Inclusion Criteria
- Subjects with advanced or metastatic solid tumors for whom the standard of care is ineffective or inappropriate
- ECOG performance status 0-1
- at least 4 weeks between surgery or last dose prior anti-cancer therapy
Exclusion Criteria
- symptomatic brain metastases
- any disorder or dysregulation of glucose homeostasis {e.g. diabetes)
- uncontrolled or significant cardiovascular disease
- inadequate bone marrow, liver or kidney function
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description BMS-754807 BMS-754807 Single arm, multiple-ascending dose escalation study
- Primary Outcome Measures
Name Time Method Safety - Toxicities will be evaluated according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE) version 3 Continuous assessment throughout the duration of the trial
- Secondary Outcome Measures
Name Time Method Pharmacokinetics assessed during the first 4 weeks of the study Pharmacodynamics assessed during the first 4 weeks of the study Metabolic measures assessed during the first 4 weeks of the study ECG assessed during the first 4 weeks of the study Efficacy Measures assessed every 8 weeks
Trial Locations
- Locations (1)
Local Institution
🇦🇺Nedlands, Western Australia, Australia