A Study of BMS-863233 in Patients With Hematologic Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2010-01-31

Brief Summary

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

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Detailed Description

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Conditions

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Refractory Hematologic Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cdc7-inhibitor (A)

Group Type ACTIVE_COMPARATOR

Cdc7-inhibitor (BMS-863233)

Intervention Type DRUG

Tablets, Oral, QD x 14 days until MTD is achieved, 14 days per 28 day cycle/QD, 12 months

Cdc7-inhibitor (B)

Group Type ACTIVE_COMPARATOR

Cdc7-inhibitor (BMS-863233)

Intervention Type DRUG

Tablets, Oral, MTD of Cdc7-inhibitor (A) Arm, QD x 7 days until MTD achieved, 7 days per 21 day cycle/QD, 12 months

Interventions

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Cdc7-inhibitor (BMS-863233)

Tablets, Oral, QD x 14 days until MTD is achieved, 14 days per 28 day cycle/QD, 12 months

Intervention Type DRUG

Cdc7-inhibitor (BMS-863233)

Tablets, Oral, MTD of Cdc7-inhibitor (A) Arm, QD x 7 days until MTD achieved, 7 days per 21 day cycle/QD, 12 months

Intervention Type DRUG

Other Intervention Names

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BMS-863233 BMS-863233

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No