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A Study of BMS-863233 in Patients With Hematologic Cancer

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Terminated
CT.gov ID
NCT00838890
Collaborator
Exelixis (Industry)
11
Enrollment
4
Locations
2
Arms
10.1
Duration (Months)
2.8
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Cdc7-inhibitor (BMS-863233)
  • Drug: Cdc7-inhibitor (BMS-863233)
 Phase 1/Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
11 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 1/2, Multiple Ascending Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BMS-863233 in Subjects With Refractory Hematologic Malignancies
Study Start Date :
Mar 1, 2009
Actual Primary Completion Date :
Jan 1, 2010
Actual Study Completion Date :
Jan 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Cdc7-inhibitor (A)

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 Names:
  • BMS-863233

    		•
    Active Comparator: Cdc7-inhibitor (B)

    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 Names:
  • BMS-863233

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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]

    2. 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]

    3. 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]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Of Miami Miami Florida United States 33136
    2 H. Lee Moffitt Cancer Center & Research Institute Tampa Florida United States 33612
    3 Massachusetts General Hospital Boston Massachusetts United States 02114
    4 Roswell Park Buffalo New York United States 14263

    Sponsors and Collaborators

    • Bristol-Myers Squibb
    • Exelixis

    Investigators

    • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Bristol-Myers Squibb
    ClinicalTrials.gov Identifier:
    NCT00838890
    Other Study ID Numbers:
    • CA198-001
    First Posted:
    Feb 9, 2009
    Last Update Posted:
    Oct 12, 2015
    Last Verified:
    Sep 1, 2015
    Additional relevant MeSH terms:
    Hematologic Neoplasms

    Study Results

    No Results Posted as of Oct 12, 2015