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Clinical Trial Summary

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).


Clinical Trial Description

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). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT00952289
Study type Interventional
Source Incyte Corporation
Contact
Status Completed
Phase Phase 3
Start date August 2009
Completion date October 2015

See also
  Status Clinical Trial Phase
Terminated NCT03123588 - Phase 2 Study of Ruxolitinib Versus Anagrelide in Subjects With Essential Thrombocythemia Who Are Resistant to or Intolerant of Hydroxyurea (RESET-272) Phase 2
Completed NCT01348490 - Ruxolitinib (INCB018424) in Participants With Primary Myelofibrosis (PMF), Post Essential Thrombocythemia-myelofibrosis and Post Polycythemia Vera-myelofibrosis (PPV-MF) Phase 2
Completed NCT02252159 - Prospective Observational Study Of Patients With Polycythemia Vera In US Clinical Practices (REVEAL)
Completed NCT01633372 - An Open Label Study of Itacitinib Administered Orally in Patients With Myelofibrosis Phase 2
Completed NCT03144687 - A Study of Itacitinib in Combination With Low-Dose Ruxolitinib or Itacitinib Alone Following Ruxolitinib in Participants With Myelofibrosis Phase 2
Completed NCT02718300 - A Study of INCB050465 in Combination With Ruxolitinib in Subjects With Myelofibrosis Phase 2
Completed NCT02953704 - Myelofibrosis and Essential Thrombocythemia Observational Study (MOST)
Active, not recruiting NCT03011372 - A Study to Evaluate the Efficacy and Safety of Pemigatinib (INCB054828) in Subjects With Myeloid/Lymphoid Neoplasms With FGFR1 Rearrangement - (FIGHT-203) Phase 2