Trial Information
Phase 1 Ascending Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) of BMS-906024 in Subjects With Relapsed/Refractory T-cell Acute Lymphoblastic Leukemia or T-cell Lymphoblastic Lymphoma
Inclusion Criteria:
- Subjects with T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma
refractory to or relapsed from standard therapies
- Life expectancy of at least 2 months
- Performance status (PS) 0-1 (a measure of the ability to carry out activities of
daily living); subjects with PS 2 are eligible if due to disease related symptoms
- Prior anti-cancer treatment permitted (with specific criteria)
- Adequate organ function
Exclusion Criteria:
- Infection
- Elevated triglycerides
- Gastro-intestinal disease with increased risk of diarrhea (e.g. inflammatory bowel
disease)
- Unable to tolerate bone marrow biopsy
- Taking medications known to increase risk of Torsades De Pointes (an abnormal heart
rhythm)
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 events as well as an assessment 30 days 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:
CA216-002
NCT ID:
NCT01363817
Start Date:
September 2011
Completion Date:
April 2014
Related Keywords:
- Lymphoblastic Leukemia, Acute T-cell
- Precursor T-Cell Lymphoblastic Lymphoma
- Leukemia
- Leukemia, Lymphoid
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Lymphoma
- Lymphoma, Non-Hodgkin
- Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
Name | Location |
Memorial Sloan Kettering Cancer Center |
New York, New York 10021 |
Dana Farber Cancer Institute |
Boston, Massachusetts 02115 |
The University of Texas MD Anderson Cancer Center |
Houston, Texas 77030-4009 |