Study of Ruxolitinib (INCB018424) Sustained Release Formulation in Myelofibrosis Patients

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Incyte Corporation
Study ID
NCT01340651
Phase
PHASE2
Status
Completed

Conditions

  • Myelofibrosis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ruxolitinib — DRUG
    Ruxolitinib was supplied as SR and IR formulated tablets.

Study Details

The purpose of this study is to determine the safety and tolerability of ruxolitinib (INCB018424) sustained release (SR) formulation in participants with primary myelofibrosis (PMF), post-polycythemia vera MF (PPV-MF), and post-essential thrombocythemia MF (PET-MF).

Key Dates

Start date
Mar 31, 2011
Status verified
Dec 2013
Primary completion
Jul 31, 2012
Completion
Jul 31, 2012

Study Design

Enrollment
41 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Ruxolitinib 25 mg SR/10, 15, or 20 mg IR
    Participants began administration with 25 mg ruxolitinib sustained release (SR) once daily (QD). After 8 weeks, if there was inadequate efficacy, the dose level could be titrated to 50 mg SR QD or 25 mg SR every other day (QOD) alternating with 50 mg SR QOD. At Week 16, participants transitioned to ruxolitinib 10, 15, or 20 mg immediate release (IR) orally twice daily. Participants who continued to demonstrate benefit in the opinion of the investigator could remain on ruxolitinib IR until the last participant completed Week 36 or the commercial availability of ruxolitinib IR, whichever was earlier; the dose received was based on platelet counts at the time of transition.

Primary Outcome Measure

Percentage of Participants With at Least 1 Adverse Event From Baseline Through Week 16 [ Time Frame: Baseline to Week 16 ]

Locations (3)

FacilityCityStateZIPSite coordinators
-ScottsdaleArizona--
-Winter ParkFlorida--
-HoustonTexasTX-

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