MPN (Myeloproliferative Neoplasms) Clinical Trial
Official title:
A Randomized, Double-blind, Placebo-controlled Study of the JAK Inhibitor INCB018424 Tablets Administered Orally to Subjects With Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis or Post-Essential Thrombocythemia Myelofibrosis
This was a randomized, double-blind study comparing the efficacy and safety of ruxolitinib (INCB018424) tablets to matching placebo tablets in patients diagnosed with Myelofibrosis (either Primary Myelofibrosis (PMF) or Post-Polycythemia Vera Myelofibrosis (PPV-MF) or Post-Essential Thrombocythemia Myelofibrosis (PET-MF).
Patients with spleen growth of greater than 25% based on an increase in spleen volume from
Baseline were eligible for early unblinding, and for patients on placebo, cross over to
ruxolitinib prior to the primary study endpoint being reached. If this spleen growth occurred
before Week 24, it must have been accompanied by specific worsening of symptoms, based on
worsening early satiety accompanied by weight loss or worsening pain requiring daily narcotic
use. After Week 24, asymptomatic spleen growth alone was sufficient for early unblinding and
potential cross over. Patients found to have been randomized to ruxolitinib after early
unblinding prior to Week 24 were discontinued.
When half of the patients remaining in the study completed the Week 36 visit and all patients
enrolled completed Week 24 or discontinued, the database was frozen and the primary analysis
was conducted. Once this was complete, all patients were unblinded and patients who had been
randomized to placebo were given the opportunity to cross over to ruxolitinib treatment,
provided hematology laboratory parameters were adequate; Patients receiving benefit could
continue treatment until the later of marketing approval or when the last randomized patient
remaining in the study had completed Week 144 (36 months).
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