Phase 1 Ascending Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) of BMS-906024 in Subjects With Advanced Solid Tumors
18 Years
N/A
Both
Cancer
Trial Information
Phase 1 Ascending Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) of BMS-906024 in Subjects With Advanced Solid Tumors
Inclusion Criteria:
- Subjects with advanced or metastatic solid tumors (non-hematologic) refractory to or
relapsed from standard therapies or for which there is no know effective treatment
during dose escalation.
- Subjects with colorectal cancer, non-small cell lung cancer, triple-negative breast
or other solid tumor types for which Notch activation has been demonstrated (such as
pancreatic, ovarian and melanoma) during dose expansion
- Biopsy accessible tumor (may be waived under certain circumstances)
- Life expectancy of at least 3 months
- Eastern Cooperative Oncology Group (ECOG) 0-1
- Adequate organ and bone marrow function
Exclusion Criteria:
- Infection
- Elevated triglycerides
- Gastrointestinal (GI) disease with increased risk of diarrhea (e.g. inflammatory
bowel disease (IBD))
- Taking medications known to increase risk of Torsades De Pointes
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Number of subjects with adverse events as a measure of safety and tolerability.
Outcome Time Frame:
Weekly assessments until study discontinuation due to disease progression or unacceptable adverse event as well as an assessment 30 day after treatment discontinuation with an average time on study expected to be <1 year.
Safety Issue:
Yes
Principal Investigator
Bristol-Myers Squibb
Investigator Role:
Study Director
Investigator Affiliation:
Bristol-Myers Squibb
Authority:
United States: Food and Drug Administration
Study ID:
CA216-001
NCT ID:
NCT01292655
Start Date:
March 2011
Completion Date:
February 2015
Related Keywords:
- Cancer
Name | Location |
|---|---|
| Wayne State University | Detroit, Michigan 48202 |
| Local Institution | Austin, Texas |
| Local Institution | Jackson, Mississippi |
| Anthony El-Khoueiry, Md | Los Angeles, California 90033 |
