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.

Gender
All

Age Group
18 Years and up

Accepting Healthy Volunteers?
No

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

IRB#IRB17-1150

Lead SponsorAbbVie

Lead PhysicianOlatoyosi Odenike

Collaborator(s)N/A

EligibilityAll
18 Years and up
Recruiting