An Open Label Assessment of Once Daily Dosing of a Sustained Release (SR) Formulation of INCB018424 in Patients With Primary Myelofibrosis, Post Essential Thrombocythemia-Myelofibrosis and Post Polycythemia Vera-Myelofibrosis
18 Years
N/A
Both
Myelofibrosis
Trial Information
An Open Label Assessment of Once Daily Dosing of a Sustained Release (SR) Formulation of INCB018424 in Patients With Primary Myelofibrosis, Post Essential Thrombocythemia-Myelofibrosis and Post Polycythemia Vera-Myelofibrosis
The study will enroll approximately 40 subjects with PMF, PPV-MF or PET-MF. Subjects will
take INCB018424 SR (ruxolitinib SR)once daily for 16 consecutive weeks and then transition
to a comparable twice daily dose regimen of INCB018424 (ruxolitinib) using the immediate
release (IR) tablets which have been under investigation in controlled Phase 1, 2 and 3
clinical trials.
The study is comprised of 4 phases:
Screening Baseline Treatment Phase (INCB018424 SR qd; 16 weeks) Extension Phase (INCB018424
IR bid).
Subjects receiving benefit from treatment with INCB018424 (ruxolitinib) may continue further
participation with IR tablets up to the time of marketing approval and commercial
availability of INCB018424 (ruxolitinib) tablets. Follow-up will occur at least 30 days
following the last dose of INCB018424 (ruxolitinib).
Inclusion Criteria:
- Subjects 18 years of age or older
- Subjects must be diagnosed with PMF, PPV-MF or PET-MF
- Subjects with MF requiring therapy must be classified as high risk (3 or more
prognostic factors), intermediate risk level 2 (2 prognostic factors) or intermediate
risk level 1 (1 prognostic factor)defined by IMG-MRT
- Subjects must have a palpable spleen measuring 5 cm or greater below the costal
margin
Exclusion Criteria:
- Subjects with a life expectancy of less than 6 months
- Subjects of childbearing potential who are unwilling to take appropriate precautions
to avoid pregnancy or fathering a child
- Subjects with inadequate bone marrow reserve
- Subjects with history of platelet counts < 50,000/μL, platelet transfusion(s) or ANC
levels < 500/μL in the month prior to Screening
- Subjects with inadequate liver or renal function at Screening and Baseline visits
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Change in platelet count from Baseline to each visit where platelet count is measured during the treatment phase of the study.
Outcome Time Frame:
Baseline and every 1-2 weeks through the Week 16 Visit or until early termination from the study.
Safety Issue:
Yes
Principal Investigator
Srdan Verstovsek, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
M.D. Anderson Cancer Center
Authority:
United States: Food and Drug Administration
Study ID:
18424-260
NCT ID:
NCT01340651
Start Date:
March 2011
Completion Date:
August 2012
Related Keywords:
- Myelofibrosis
- Myelofibrosis
- myeloproliferative neoplasms
- PMF, PET-MF and PPV-MF
- Primary Myelofibrosis
- Thrombocythemia, Essential
Name | Location |
|---|---|
| Phoenix, Arizona 85012 | |
| Miami, Florida 33176 | |
| Austin, Texas 78705 |
