Trial Information
A Phase I Multiple Ascending Dose Study of BMS-754807 in Combination With Paclitaxel and Carboplatin in Subjects With Advanced or Metastatic Solid Tumors
Inclusion Criteria:
- Subjects with advanced or metastatic solid tumors for whom carboplatin and paclitaxel
is considered an appropriate therapy
- 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
- Evidence of > Grade 1 peripheral neuropathy
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Safety: Toxicities will be evaluated according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE) version 3
Outcome Time Frame:
Continuous assessment throughout the duration of the trial: starting with dosing on Day 1 until after 30 day follow-up following the last dose
Safety Issue:
Yes
Principal Investigator
Bristol-Myers Squibb
Investigator Role:
Study Director
Investigator Affiliation:
Bristol-Myers Squibb
Authority:
Canada: Health Canada
Study ID:
CA191-005
NCT ID:
NCT00793897
Start Date:
April 2009
Completion Date:
June 2012
Related Keywords:
- Advanced Solid Tumors
- Metastatic Solid Tumors
- Subjects with Advanced or Metastatic Solid Tumors or Neoplasms
- Neoplasms