A Study of Venetoclax and Dinaciclib (MK7965) in Patients With Relapsed/Refractory Acute Myeloid Leukemia

Study Identifier
M16-183
CT.gov Identifier
NCT03484520
EudraCT Identifier
2017-003213-26
EUCTIS ID
Not available
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Study Details

Medical Condition
  • Blood Cancer - Acute Myeloid Leukemia (AML)
    • Study Drug
  • Venetoclax
  • Dinaciclib
    • Phase
    Phase 1
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Diagnosis of acute myeloid leukemia (AML) by World Health Organization criteria excluding acute promyelocytic leukemia (APL)-M3. * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2. * Participant must have adequate hematologic, renal, and liver function laboratory values as described in the protocol.
    Exclusion Criteria:
    * Known central nervous system leukemia * Severe chronic obstructive pulmonary disease (COPD) with hypoxemia * History of any malignancy within the last 6 months except for those specified in this protocol and low-grade malignancies not requiring active treatment. * Prior allogeneic stem cell transplant within 6 months of study drug administration and no requirement for graft versus host therapy. * History of clinically significant medical condition that, in the opinion of the investigator, would adversely affect participation in this study. * Known active infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C. * History of tumor lysis syndrome (TLS) due to previous exposure to venetoclax.

    Protocol Summary

    An open-label, dose-escalation study to assess safety, pharmacokinetics and efficacy as well as determine the recommended Phase 2 doses of co-administered therapy of dinaciclib and venetoclax for patients with relapsed or refractory Acute Myeloid Leukemia (R/R AML).

    Study Locations

    Location
    Status
    Location
    University of Arkansas /ID# 200016
    Little Rock, Arkansas, United States, 72205
    Status
    Not applicable
    Location
    David Geffen School of Medicin /ID# 200015
    Los Angeles, California, United States, 90095
    Status
    Not applicable
    Location
    The University ofChicago /ID# 200017
    Chicago, Illinois, United States, 60637
    Status
    Not applicable
    Location
    University of Maryland School of Medicine /ID# 204015
    Baltimore, Maryland, United States, 21201-1544
    Status
    Not applicable
    Location
    Wake Forest Baptist Medical Center /ID# 200288
    Winston-Salem, North Carolina, United States, 27157-0001
    Status
    Not applicable
    Location
    The Ohio State University /ID# 200668
    Columbus, Ohio, United States, 43210
    Status
    Not applicable
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