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

  • Interventional
  • Recruiting
  • NCT03222609
Eligibility Details Visit Clinicaltrials.gov

A Phase 2 Open-Label Study Evaluating Tolerability and Efficacy of Navitoclax Alone or in Combination With Ruxolitinib in Subjects With Myelofibrosis

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.


Age Group
18 Years and up

Accepting Healthy Volunteers?

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.

At a Glance

National Government IDNCT03222609


Lead SponsorAbbVie

Lead PhysicianOlatoyosi Odenike


18 Years and up