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

February 6, 2009
January 24, 2011
March 2009
November 2009   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00838890 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Study of BMS-863233 in Patients With Hematologic Cancer
A Phase 1/2, Multiple Ascending Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BMS-863233 in Subjects With Refractory Hematologic Malignancies

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

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Refractory Hematologic Cancer
  • 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
  • Active Comparator: Cdc7-inhibitor (A)
    Intervention: Drug: Cdc7-inhibitor (BMS-863233)
  • Active Comparator: Cdc7-inhibitor (B)
    Intervention: Drug: Cdc7-inhibitor (BMS-863233)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
90
November 2009
November 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00838890
CA198-001
Not Provided
Study Director, Bristol-Myers Squibb
Bristol-Myers Squibb
Exelixis
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
October 2010

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