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A Study of BMS-863233 in Patients With Hematologic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00838890
Recruitment Status : Terminated
First Posted : February 9, 2009
Last Update Posted : October 12, 2015
Sponsor:
Collaborator:
Exelixis
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE February 6, 2009
First Posted Date  ICMJE February 9, 2009
Last Update Posted Date October 12, 2015
Study Start Date  ICMJE March 2009
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 6, 2009)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 6, 2009)
  • 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 ]
  • 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 ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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 Arms  ICMJE
  • 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
Actual Enrollment  ICMJE
 (submitted: September 23, 2015)
11
Original Estimated Enrollment  ICMJE
 (submitted: February 6, 2009)
90
Actual Study Completion Date  ICMJE January 2010
Actual Primary Completion Date January 2010   (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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00838890
Other Study ID Numbers  ICMJE CA198-001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bristol-Myers Squibb
Study Sponsor  ICMJE Bristol-Myers Squibb
Collaborators  ICMJE Exelixis
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date September 2015

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