A Study of BMS-863233 in Patients With Hematologic Cancer

Stopped early · Phase 1/Phase 2

Conditions studied: Refractory Hematologic Cancer

In brief

To determine safety, tolerability and maximum tolerated dose of BMS-63233/XL413 in subjects with Refractory Hematologic Cancer

Key facts

Study ID

NCT00838890

Run by

Bristol-Myers Squibb

People needed

11

Starts

2009-03-01

Expected to finish

2010-01-01

Last updated by the study team

2015-10-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University Of Miami — Miami, Florida, United States
• H. Lee Moffitt Cancer Center & Research Institute — Tampa, Florida, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Roswell Park — Buffalo, New York, United States

Full record on ClinicalTrials.gov

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