Clinical Trials (PDQ®)
|Phase III||Treatment||Closed||18 and over||Pharmaceutical / Industry||INCB 18424-351|
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).
Further Study Information
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, crossover 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 crossover. 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 crossover 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).
- Subjects must be diagnosed with primary myelofibrosis (PMF), post-polycythemia vera-myelofibrosis (PPV-MF) or post-essential thrombocythemia-myelofibrosis (PET-MF) according to the 2008 World Health Organization criteria
- Subjects with myelofibrosis requiring therapy must be classified as high risk OR intermediate risk level 2 according to the prognostic factors defined by the International Working Group
- Subjects with an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, 2 or 3
- Subjects who have not previously received treatment with a Janus kinase (JAK) inhibitor
- Subjects with a life expectancy of less than 6 months
- Subjects with inadequate bone marrow reserve as demonstrated by specific clinical laboratory counts
- Subjects with inadequate liver or renal function
- Subjects with clinically significant bacterial, fungal, parasitic or viral infection which require therapy
- Subjects with an active malignancy over the previous 5 years except specific skin cancers.
- Subjects with severe cardiac conditions
- Subjects who have had splenic irradiation within 12 months
Trial Lead Organizations/Sponsors
|Srdan Verstovsek||Study Director|
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00952289
ClinicalTrials.gov processed this data on September 16, 2014
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