A Study of BMS-863233 in Patients With Hematologic Cancer

This study has been terminated.

Sponsor:

Collaborator:

Exelixis

Information provided by:

Bristol-Myers Squibb

ClinicalTrials.gov Identifier:

NCT00838890

First received: February 6, 2009

Last updated: January 24, 2011

Last verified: October 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

February 6, 2009

Last Updated Date

January 24, 2011

Start Date ^ICMJE

March 2009

Estimated Primary Completion Date

November 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

To determine maximum tolerated dose and anti-tumor activity of BMS-863233/XL413 when administered to subjects with refractory Hematologic Cancer [ Time Frame: Every 21 or 28 days until maximum tolerated dose is reached ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00838890 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To determine the safety of BMS-863233/XL413 when administered to subjects with refractory Hematologic Cancer [ Time Frame: Every 21 or 28 days until the MTD is reached ] [ Designated as safety issue: Yes ]
To determine the pharmacokinetics of BMS-863233/XL413 when administered to subjects with refractory Hematologic Cancer [ Time Frame: Every 21 or 28 days until the MTD is reached ] [ Designated as safety issue: No ]
To determine the anti-tumor activity of BMS-863233/XL413 when administered to subjects with refractory Hematologic Cancer [ Time Frame: Every 21 or 28 days until the MTD is reached ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

A Study of BMS-863233 in Patients With Hematologic Cancer

Official Title ^ICMJE

A Phase 1/2, Multiple Ascending Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BMS-863233 in Subjects With Refractory Hematologic Malignancies

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1
Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Refractory Hematologic Cancer

Intervention ^ICMJE

Drug: Cdc7-inhibitor (BMS-863233)
Tablets, Oral, QD x 14 days until MTD is achieved, 14 days per 28 day cycle/QD, 12 months

Other Name: BMS-863233
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

Other Name: BMS-863233

Study Arm (s)

Active Comparator: Cdc7-inhibitor (A)
Intervention: Drug: Cdc7-inhibitor (BMS-863233)
Active Comparator: Cdc7-inhibitor (B)
Intervention: Drug: Cdc7-inhibitor (BMS-863233)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Estimated Enrollment ^ICMJE

Estimated Completion Date

November 2009

Estimated Primary Completion Date

November 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00838890

Other Study ID Numbers ^ICMJE

CA198-001

Has Data Monitoring Committee

Not Provided

Responsible Party

Study Director, Bristol-Myers Squibb

Study Sponsor ^ICMJE

Bristol-Myers Squibb

Collaborators ^ICMJE

Exelixis

Investigators ^ICMJE

Study Director:

Bristol-Myers Squibb

Information Provided By

Bristol-Myers Squibb

Verification Date

October 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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