Comprehensive Cancer Centers of Nevada | Las Vegas, NV
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About
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.
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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 due to age, comorbidities, or unfit for unrelated or unmatched donor transplantation or unwilling to undergo stem cell transplantation at time of study entry.
Eastern Cooperative Oncology Group (ECOG) of 0, 1, or 2.
Prior treatment must meet at least one of the following criteria:
Prior or current treatment with ruxolitinib and no prior treatment with a Bromodomain and Extra-Terminal motif (BET) proteins inhibitor or another Janus Kinase 2 (JAK-2) inhibitor, and meet all of the following criteria:
Ruxolitinib treatment must meet at least one of the following criteria:
If receiving ruxolitinib at the time of screening, must currently be on a stable dose >=10 mg twice daily of ruxolitinib for >=4 weeks prior to the 1st dose of navitoclax.
Participant has at least 2 symptoms each with a score >=3 or a total score of >=12, as measured by the Myelofibrosis Symptom Assessment Form (MFSAF) v4.0 on at least 4 out of 7 days during screening prior to study drug dosing; OR
Prior treatment with a JAK-2 inhibitor and meet one of the following criteria:
No prior treatment with a JAK-2 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
Primary purpose
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191 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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