A Study of the Safety and Pharmacokinetics of Venetoclax in Pediatric and Young Adult Patients With Relapsed or Refractory Malignancies

Study Identifier
M13-833
CT.gov Identifier
EudraCT Identifier
EUCTIS ID
Not available
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Study Complete

Study Details

Medical Condition
  • Cancer - Other
  • Blood Cancer - Acute Lymphoblastic Leukemia (ALL)
  • Blood Cancer - Acute Myeloid Leukemia (AML)
  • Blood Cancer - Non-Hodgkin's Lymphoma (General)
  • Study Drug
  • chemotherapy
  • venetoclax
  • Phase
    Phase 1
    Sex
    Female & Male
    Age
    0 - 25 Years

    Protocol Summary

    An open-label, global, multi-center study to evaluate the safety and pharmacokinetics of venetoclax monotherapy, to determine the dose limiting toxicity (DLT) and the recommended Phase 2 dose (RPTD), and to assess the preliminary efficacy of venetoclax in pediatric and young adult participants with relapsed or refractory malignancies.

    Study Locations

    Location
    Status
    Location
    Univ California, San Francisco /ID# 163460
    San Francisco, California, United States, 94143-2204
    Status
    Not applicable
    Location
    Children's Hospital Colorado /ID# 161551
    Aurora, Colorado, United States, 80045
    Status
    Not applicable
    Location
    Children's Healthcare of Atlan /ID# 161552
    Atlanta, Georgia, United States, 30322
    Status
    Not applicable
    Location
    Dana-Farber Cancer Institute /ID# 163440
    Boston, Massachusetts, United States, 02215
    Status
    Not applicable
    Location
    Memorial Sloan Kettering Cancer Center-Koch Center /ID# 163444
    New York, New York, United States, 10065-6007
    Status
    Not applicable
    Location
    Cincinnati Children's Hospital /ID# 161550
    Cincinnati, Ohio, United States, 45229
    Status
    Not applicable
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