A Phase I Multiple Ascending Dose Study of BMS-754807 in Subjects With Advanced or Metastatic Solid Tumors
Phase 1
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Neoplasms, Solid Tumors, Metastases
Both
Neoplasms, Solid Tumors, Metastases
Trial Information
A Phase I Multiple Ascending Dose Study of BMS-754807 in Subjects With Advanced or Metastatic Solid Tumors
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
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
Safety Issue:
Yes
Principal Investigator
Bristol-Myers Squibb
Investigator Role:
Study Director
Investigator Affiliation:
Bristol-Myers Squibb
Authority:
Australia: Department of Health and Ageing Therapeutic Goods Administration
Study ID:
CA191-002
NCT ID:
NCT00569036
Start Date:
April 2008
Completion Date:
September 2012
Related Keywords:
- Neoplasms
- Solid Tumors
- Metastases
- Advanced or Metastatic Solid Tumors or Neoplasms
- Neoplasms
- Neoplasm Metastasis
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