A Study Evaluating Safety and Tolerability, and Pharmacokinetics of Navitoclax Monotherapy and in Combination With Ruxolitinib in Participants With Myeloproliferative Neoplasm

Study Identifier
M19-753
CT.gov Identifier
EudraCT Identifier
EUCTIS ID
Not available
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Study Details

Medical Condition
  • Solid Tumors (General)
  • Study Drug
  • Navitoclax
  • Ruxolitinib
  • Celecoxib
  • Phase
    Phase 1
    Sex
    Female & Male
    Age
    18+ years

    Protocol Summary

    There are 5 parts to this study for which the primary objectives are to evaluate safety, tolerability, and pharmacokinetics (PK) of navitoclax when administered alone (Part 1) or when administered in combination with ruxolitinib (Part 2). In Part 2, participants must have been receiving a stable dose of ruxolitinib therapy for at least 12 weeks prior to study enrollment. In Part 3, all eligible participants will receive navitoclax, with the primary objective being to evaluate potential navitoclax effect on QTc prolongation. In Part 4, effect of navitoclax is evaluated on the PK, safety, and tolerability of a single dose of celecoxib. In Part 5, all eligible participants will receive ruxolitinib twice daily and navitoclax once daily for drug-drug interaction (DDI) assessment, followed by continued administration of navitoclax in combination with ruxolitinib.

    Study Locations

    Location
    Status
    Location
    City of Hope /ID# 239769
    Duarte, California, United States, 91010
    Status
    Not applicable
    Location
    Providence - St. Jude Medical Center /ID# 242558
    Fullerton, California, United States, 92835
    Status
    Not applicable
    Location
    Moores Cancer Center at UC San Diego /ID# 229584
    La Jolla, California, United States, 92093
    Status
    Not applicable
    Location
    UCLA /Id# 222784
    Los Angeles, California, United States, 90095-1678
    Status
    Not applicable
    Location
    Northwestern University Feinberg School of Medicine /ID# 224203
    Chicago, Illinois, United States, 60611-2927
    Status
    Not applicable
    Location
    Norton Cancer Institute - St. Matthews /ID# 239300
    Louisville, Kentucky, United States, 40207
    Status
    Not applicable
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