A Study of ABT-263 in Subjects With Relapsed or Refractory Lymphoid Malignancies

Study Identifier
M06-814
CT.gov Identifier
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact
Study Complete

Study Details

Medical Condition
  • Blood Cancer - Chronic Lymphocytic Leukemia (CLL)
  • Blood Cancer - Other
  • Blood Cancer - Non-Hodgkin's Lymphoma (General)
  • Blood Cancer - Follicular Lymphoma (FL)
  • Blood Cancer - Mantle Cell Lymphoma (MCL)
  • Study Drug
  • ABT-263
  • Phase
    Phase 1/Phase 2
    Sex
    Female & Male
    Age
    18 - 99 Years

    Protocol Summary

    The Phase 1 portion of the study evaluated the pharmacokinetic profile and safety of ABT-263 with the objective of defining the dose limiting toxicity and maximum tolerated dose in subjects with lymphoid malignancies. The Phase 2a portion of the study is evaluating ABT-263 using a step-up dosing regimen and may be increased to the defined recommended Phase 2 dose to obtain additional safety information and a preliminary assessment of efficacy in subject with lymphoid malignancies. The Extension portion of the study is to allow Phase 2a subjects who remain active 1 year after the last subject enrolls or who have been on study approximately 1 year to continue receiving ABT-263 with less frequent study evaluations. Subjects in the Extension Study will continue receiving study drug for up to 7 years after the last subject transitions to the Extension Study, or until disease progression or toxicity that necessitates discontinuation (whichever comes first).

    Study Locations

    Location
    Status
    Location
    Site Reference ID/Investigator# 4997
    Los Angeles, California, United States, 90033
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 9104
    Los Angeles, California, United States, 90095
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 2613
    Bethesda, Maryland, United States, 20892
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 40243
    Boston, Massachusetts, United States, 02215
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 4745
    Boston, Massachusetts, United States, 02215
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 2628
    Buffalo, New York, United States, 14263
    Status
    Not applicable
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