A Phase 1 Study Evaluating the Safety and Pharmacokinetics of ABT-199 in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia and Non-Hodgkin Lymphoma

Study Identifier
M12-175
CT.gov Identifier
EudraCT Identifier
Not available
EUCTIS ID
Not available
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Study Complete

Results Available

Scientific Result Summary
Available Language(s): English

Study Details

Medical Condition
  • Blood Cancer - Chronic Lymphocytic Leukemia (CLL)
  • Blood Cancer - Non-Hodgkin's Lymphoma (General)
  • Study Drug
  • ABT-199
  • Phase
    Phase 1
    Sex
    Female & Male
    Age
    18 - 99 Years

    Protocol Summary

    This is a Phase 1, open-label, multicenter study evaluating the safety and PK profile of ABT-199 under a once daily dosing schedule. Two arms will be implemented for dose escalation: Arm A, CLL/SLL subjects and Arm B, NHL subjects. Arm A is designed to enroll approximately 116 subjects with relapsed or refractory CLL or SLL and Arm B is designed to enroll approximately 95 subjects with relapsed or refractory NHL. Fifty-six subjects were enrolled in Arm A and approximately 55 subjects will be enrolled in Arm B during the dose escalation portion of the study, with the objective of defining dose limiting toxicities (DLTs) and the MTD. Once the MTD is declared for the arm, approximately 60 additional CLL/SLL subjects in Arm A and approximately 20 additional DLBCL subjects and 20 additional follicular lymphoma subjects in Arm B will be enrolled in an expanded safety portion of the study at the recommended phase 2 dose (RPTD) and schedule.

    Study Locations

    Location
    Status
    Location
    University of Arizona Cancer Center - North Campus /ID# 52902
    Tucson, Arizona, United States, 85719-1478
    Status
    Not applicable
    Location
    Ucsd /Id# 48325
    La Jolla, California, United States, 92093
    Status
    Not applicable
    Location
    Dana-Farber Cancer Institute /ID# 48324
    Boston, Massachusetts, United States, 02215
    Status
    Not applicable
    Location
    Memorial Sloan Kettering Cancer Center /ID# 56810
    New York, New York, United States, 10065-6007
    Status
    Not applicable
    Location
    University of Texas MD Anderson Cancer Center /ID# 48326
    Houston, Texas, United States, 77030
    Status
    Not applicable
    Location
    Swedish Medical Center /ID# 135853
    Seattle, Washington, United States, 98104
    Status
    Not applicable
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