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

Inclusion Criteria

• Participants with documented diagnosis of intermediate 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
• ECOG of 0,1, or 2.
• Participant must have either received prior treatment with ruxolitinib OR another JAK-2 inhibitor therapy OR must not have received any prior treatment with JAK-2 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.

Lead Organization
Abbvie