A Study of BMS-863233 in Patients With Hematologic Cancer

Phase 1

Terminated

• Conditions: Refractory Hematologic Cancer
• Interventions: Drug: Cdc7-inhibitor (BMS-863233)

• Registration Number: NCT00838890
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-02-06
• Study First Submitted QC: 2009-02-06
• Study First Posted: 2009-02-09
• Study Start: 2009-03
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Disposition First Submitted: 2011-06-21
• Status Verified: 2015-09
• Disposition First Submitted QC: 2015-09-23
• Last Update Submitted: 2015-09-23
• Disposition First Posted: 2015-10-12
• Last Update Posted: 2015-10-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 11

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cdc7-inhibitor (A)	Cdc7-inhibitor (BMS-863233)	-
Cdc7-inhibitor (B)	Cdc7-inhibitor (BMS-863233)	-

Primary Outcome Measures

Name	Time	Method
To determine maximum tolerated dose and anti-tumor activity of BMS-863233/XL413 when administered to subjects with refractory Hematologic Cancer	Every 21 or 28 days until maximum tolerated dose is reached

Secondary Outcome Measures

Name	Time	Method
To determine the pharmacokinetics of BMS-863233/XL413 when administered to subjects with refractory Hematologic Cancer	Every 21 or 28 days until the MTD is reached
To determine the anti-tumor activity of BMS-863233/XL413 when administered to subjects with refractory Hematologic Cancer	Every 21 or 28 days until the MTD is reached
To determine the safety of BMS-863233/XL413 when administered to subjects with refractory Hematologic Cancer	Every 21 or 28 days until the MTD is reached

Trial Locations

Locations (4)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

H. Lee Moffitt Cancer Center & Research Institute; 🇺🇸 Tampa, Florida, United States

Roswell Park; 🇺🇸 Buffalo, New York, United States

University Of Miami; 🇺🇸 Miami, Florida, United States