Open Label Ruxolitinib (INCB018424) in Patients With Myelofibrosis and Post Polycythemia Vera/Essential Thrombocythemia Myelofibrosis

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Incyte Corporation
Study ID
NCT00509899
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Myelofibrosis
  • Polycythemia Vera
  • Thrombocytosis

Eligibility Criteria

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

Interventions

  • Ruxolitinib — DRUG
    5 and 25 mg tablets with a daily dosing range from 10 to 200 mg qd or bid.

Study Details

To determine the safety, tolerability and effectiveness of ruxolitinib (INCB018424), administered orally to patients with Primary Myelofibrosis (PMF), Post Polycythemia Vera Myelofibrosis (PPV-MF) and Essential Thrombocythemia Myelofibrosis (PET-MF).

Key Dates

Start date
Jun 30, 2007
Status verified
Feb 2018
Primary completion
Dec 31, 2007
Completion
Feb 28, 2017

Study Design

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

Arms

  • Experimental: Ruxolitinib
    All participants received oral ruxolitinib. Patients began treatment with either 10 mg twice a day (bid), 15 mg bid, 25 mg bid, 50 mg bid, 25 mg once a day (qd), 50 mg qd, 100 mg qd, or 200 mg qd, depending on the time period when they entered the study. The doses were titrated based on efficacy and safety to a maximum of 25 mg bid for patients who entered the study after sufficient dosing information had been obtained to define the maximum dose for patients in the study. Patients could continue receiving treatment indefinitely if receiving benefit at a dose that continues to maintain benefit but does not exceed a maximum dose of 25 mg BID.

Primary Outcome Measure

Number of Participants With Adverse Events (AEs) [ Time Frame: From Baseline to the interim clinical cut-off date (31 December 2009). The median time on study was 14.8 months, with a range of 26 days to 29.7 months. As of March 1, 2011 the total exposure to ruxolitinib was 269 patient-years. ]

Locations (2)

FacilityCityStateZIPSite coordinators
-RochesterMinnesota--
-HoustonTexas--

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