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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Myelofibrosis

Thank you

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