A Study of ABT-263 in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia

Study Identifier
M06-873
CT.gov Identifier
NCT00481091
EudraCT Identifier
2007-002143-25
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Results Available

Protocol
Available Language(s): English
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Statistical Analysis Plan
Available Language(s): English
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Plain Language Summary
Available Language(s): English, German
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Study Details

Medical Condition
  • Blood Cancer - Chronic Lymphocytic Leukemia (CLL)
    • Study Drug
  • ABT-263
    • Phase
    Phase 1/Phase 2
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Relapsed or refractory CLL and require treatment in opinion of investigator. * Eastern Cooperative Oncology Group (ECOG) \<= 1. * Adequate bone marrow independent of growth factor support, renal and hepatic function per defined laboratory criteria.
    Exclusion Criteria:
    * History or is clinically suspicious for cancer-related Central Nervous System disease. * Receipt of allogenic or autologous stem cell transplant. * Recent history (within 1 year of first dose) of underlying, predisposing condition of bleeding or currently exhibits signs of bleeding. * Active peptic ulcer disease or other potentially hemorrhagic esophagitis/gastritis. * Active immune thrombocytopenic purpura or history of being refractory to platelet transfusions (within 1 year of first dose).

    Protocol Summary

    The Phase 1 portion of the study will evaluate the pharmacokinetic profile and safety of ABT-263 under two different dosing schedules with the objective of defining the dose limiting toxicity and maximum tolerated dose. The Phase 2a portion of the study will evaluate ABT-263 at the defined recommended Phase 2 dose to obtain additional safety information and a preliminary assessment of efficacy. The Extension Study portion will allow active subjects to continue to receive ABT-263 for up to 11 years after the last subject transitions with less frequent study evaluations.

    Study Locations

    Location
    Status
    Location
    Moores Cancer Center at UC San Diego /ID# 5566
    La Jolla, California, United States, 92093
    Status
    Not applicable
    Location
    Dana-Farber Cancer Institute /ID# 5547
    Boston, Massachusetts, United States, 02215
    Status
    Not applicable
    Location
    University of Nebraska Medical Center /ID# 12261
    Omaha, Nebraska, United States, 68198
    Status
    Not applicable
    Location
    North Shore University Hospital /ID# 12267
    New Hyde Park, New York, United States, 11040
    Status
    Not applicable
    Location
    University of Texas MD Anderson Cancer Center /ID# 5575
    Houston, Texas, United States, 77030
    Status
    Not applicable
    Location
    Northwest Medical Specialties - Tacoma /ID# 26428
    Tacoma, Washington, United States, 98405
    Status
    Not applicable
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