Study of the JAK Inhibitor Ruxolitinib Administered Orally to Patients With Primary Myelofibrosis (PMF), Post-Polycythemia Vera-Myelofibrosis (PPV-MF) or Post-Essential Thrombocythemia-Myelofibrosis (PET-MF)

Part of paid clinical trials in Winter Park, Florida.

Sponsor
Incyte Corporation
Study ID
NCT01317875
Phase
PHASE1
Status
Completed

Conditions

  • Myelofibrosis

Eligibility Criteria

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

Interventions

  • Ruxolitinib — DRUG
    Starting dose of ruxolitinib for cohort 1 in dose escalation phase - 5mg twice a day (BID) Doses will be increased a total of approximately 5mg for successive dosing cohorts based on baseline platelet count

Study Details

This is a Phase IB, open-label, dose-finding study of the JAK 1 and 2 inhibitor ruxolitinib in patients with myelofibrosis (MF). The study consists of two periods: the core study period, comprising the dose escalation stage and the safety extension phase up to Week 24, then the extension study period beyond Week 24 and up to 3 years, to further characterize the safety and efficacy of ruxolitinib in this patient population. The dose escalation phase will enroll successive cohorts of patients who receive increasing doses of ruxolitinib until the maximum safe starting dose (MSSD) is determined. In the safety expansion phase, additional patients will be treated with ruxolitinib at the MSSD defined during dose escalation. The primary objective is to establish the MSSD of ruxolitinib in patients with MF and starting platelet counts \< 100 x 10 \^9/L

Key Dates

Start date
Mar 31, 2011
Status verified
Aug 2025
Primary completion
Dec 31, 2019
Completion
Dec 31, 2019

Study Design

Enrollment
69 participants (actual)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Stratum -1
    Participants with baseline Platelet counts of 75-99 x10\^9/L
  • Experimental: Stratum -2
    Participants with baseline Platelet counts of 50-74 x10\^9/L

Primary Outcome Measure

Number of Participants With Dose Limiting Toxicities [ Time Frame: 28 days ]

Locations (3)

FacilityCityStateZIPSite coordinators
-Winter ParkFlorida32789-
-BaltimoreMaryland21229-
-HoustonTexas77030-

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