A Study of BMS-863233 in Patients With Hematologic Cancer

Bristol-Myers Squibb (BMS)

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Refractory Hematologic Cancer

Treatments: Drug: Cdc7-inhibitor (BMS-863233)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00838890

CA198-001

Details and patient eligibility

About

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

Enrollment: 11 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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11 participants in 2 patient groups

Cdc7-inhibitor (A)

Active Comparator group

Treatment:

Drug: Cdc7-inhibitor (BMS-863233)

Drug: Cdc7-inhibitor (BMS-863233)

Cdc7-inhibitor (B)

Active Comparator group

Treatment:

Drug: Cdc7-inhibitor (BMS-863233)

Drug: Cdc7-inhibitor (BMS-863233)