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.
- 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.
- 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.
University of Alabama at Birmingham Cancer Center
Contact: Nikolaos Papadantonakis
City of Hope Comprehensive Cancer Center
USC / Norris Comprehensive Cancer Center
Contact: Christine Duran
University of California San Diego
Mayo Clinic in Florida
Moffitt Cancer Center
Contact: Rami S. Komrokji
University of Chicago Comprehensive Cancer Center
Brigham and Women's Hospital
Dana-Farber Cancer Institute
Ohio State University Comprehensive Cancer Center
Medical University of South Carolina
M D Anderson Cancer Center
Cancer Therapy and Research Center at The UT Health Science Center at San Antonio
Contact: Sonia Lisa Creighton
Salt Lake City
Huntsman Cancer Institute / University of Utah
Trial Phase Phase II
Trial Type Treatment
- Primary ID M16-109
- Secondary IDs NCI-2017-01899, 2017-001398-17
- Clinicaltrials.gov ID NCT03222609