A Study of BMS-863233 in Patients With Hematologic Cancer

• Status: Terminated
• Trial end date: 2010-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Collaborator: Exelixis

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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