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A Study Evaluating Tolerability and Efficacy of Navitoclax Alone or in Combination With Ruxolitinib in Participants With Myelofibrosis

Trial Status: Active

This is a Phase 2 open-label, multicenter study evaluating tolerability and efficacy of navitoclax alone or when added to ruxolitinib in participants with myelofibrosis.

Inclusion Criteria

  • Participants with documented diagnosis of intermediate-2 or high-risk primary Myelofibrosis, Post Polycythemia Vera Myelofibrosis or Post-essential Thrombocythemia Myelofibrosis.
  • Participant must be ineligible or unwilling to undergo stem cell transplantation at time of study entry.
  • Eastern Cooperative Oncology Group (ECOG) of 0,1, or 2.
  • Participant must have either received prior treatment with ruxolitinib OR another Janus Kinase 2 (JAK-2) inhibitor therapy OR must not have received any prior treatment with JAK-2 inhibitor or BET inhibitor.
  • Participant has splenomegaly as defined in the protocol.
  • Participant must meet the laboratory parameters (adequate bone marrow, renal and hepatic function) as defined in the protocol.

Exclusion Criteria

  • Splenic irradiation within 6 months prior to screening, or prior splenectomy.
  • Leukemic transformation (> 10% blasts in peripheral blood or bone marrow biopsy).
  • Participant is currently on medications that interfere with coagulation (including warfarin) or platelet function with the exception of low dose aspirin (up to 100 mg) and Low-molecular-weight heparin.
  • Prior therapy with a BH3 mimetic compound.
  • Participant has received strong or moderate CYP3A inhibitors within 14 days prior to the administration of the first dose of navitoclax.

Alabama

Birmingham
University of Alabama at Birmingham Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Nikolaos Papadantonakis
Phone: 205-934-0916

California

Los Angeles
USC / Norris Comprehensive Cancer Center
Status: ACTIVE
Contact: Christine Duran
Phone: 323-865-0371
San Diego
University of California San Diego
Status: CLOSED_TO_ACCRUAL

Florida

Jacksonville
Mayo Clinic in Florida
Status: ACTIVE
Tampa
Moffitt Cancer Center
Status: ACTIVE
Contact: Rami S. Komrokji
Phone: 813-745-4291

Illinois

Chicago
University of Chicago Comprehensive Cancer Center
Status: ACTIVE

Massachusetts

Boston
Brigham and Women's Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Dana-Farber Cancer Institute
Status: TEMPORARILY_CLOSED_TO_ACCRUAL

Ohio

Columbus
Ohio State University Comprehensive Cancer Center
Status: APPROVED

South Carolina

Charleston
Medical University of South Carolina
Status: IN_REVIEW

Texas

Houston
M D Anderson Cancer Center
Status: ACTIVE
San Antonio
Cancer Therapy and Research Center at The UT Health Science Center at San Antonio
Status: ADMINISTRATIVELY_COMPLETE
Contact: Sonia Lisa Creighton
Phone: 210-450-1366

Utah

Salt Lake City
Huntsman Cancer Institute / University of Utah
Status: ACTIVE

Trial Phase Phase II

Trial Type Treatment

Lead Organization
Abbvie

  • Primary ID M16-109
  • Secondary IDs NCI-2017-01899, 2017-001398-17
  • Clinicaltrials.gov ID NCT03222609