Status:
TERMINATED
A Study of BMS-863233 in Patients With Hematologic Cancer
Lead Sponsor:
Bristol-Myers Squibb
Collaborating Sponsors:
Exelixis
Conditions:
Refractory Hematologic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
To determine safety, tolerability and maximum tolerated dose of BMS-63233/XL413 in subjects with Refractory Hematologic Cancer
Eligibility Criteria
Inclusion
- AML by current WHO diagnostic criteria, any FAB type (except APML), Refractory ALL, Accelerated/blast phase CML and Refractory MDS with total IPSS score of 2 or higher
- ECOG performance status \<= 2
- Accessible for treatment, PK sample collection and required study follow-up
- Total Bilirubin ≤ 1.5 x ULN and ALT, AST ≤ 3 x ULN
Exclusion
- Women who are pregnant or breastfeeding
- Subjects with Acute Promyelocytic leukemia disease or CNS leukemia disease)
- Hyperleukocytosis (defined as peripheral WBC \>50,000/uL)
- Treatment with any other investigational agent for any indication within 30 days of protocol enrollment
- Subjects a history of gastrointestinal disease
- Subjects less than four weeks from allogenic or autologous stem cell transplant infusion
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT00838890
Start Date
March 1 2009
End Date
January 1 2010
Last Update
October 12 2015
Active Locations (4)
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1
University Of Miami
Miami, Florida, United States, 33136
2
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States, 33612
3
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
4
Roswell Park
Buffalo, New York, United States, 14263