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A Randomized, Double-blind, Placebo-controlled Study of the JAK Inhibitor INCB018424 Tablets Administered Orally to Subjects With Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis or Post-Essential Thrombocythemia Myelofibrosis

Phase 3
18 Years
Open (Enrolling)

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Trial Information

A Randomized, Double-blind, Placebo-controlled Study of the JAK Inhibitor INCB018424 Tablets Administered Orally to Subjects With Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis or Post-Essential Thrombocythemia Myelofibrosis

Patients with spleen growth of greater than 25% based on an increase in spleen volume from
Baseline were eligible for early unblinding, and for patients on placebo, crossover to
ruxolitinib prior to the primary study endpoint being reached. If this spleen growth
occurred before Week 24, it must have been accompanied by specific worsening of symptoms,
based on worsening early satiety accompanied by weight loss or worsening pain requiring
daily narcotic use. After Week 24, asymptomatic spleen growth alone was sufficient for early
unblinding and potential crossover. Patients found to have been randomized to ruxolitinib
after early unblinding prior to Week 24 were discontinued.

When half of the patients remaining in the study completed the Week 36 visit and all
patients enrolled completed Week 24 or discontinued, the database was frozen and the primary
analysis was conducted. Once this was complete, all patients were unblinded and patients who
had been randomized to placebo were given the opportunity to crossover to ruxolitinib
treatment, provided hematology laboratory parameters were adequate; Patients receiving
benefit could continue treatment until the later of marketing approval or when the last
randomized patient remaining in the study had completed Week 144 (36 months).

Inclusion Criteria:

- Subjects must be diagnosed with primary myelofibrosis (PMF), post-polycythemia
vera-myelofibrosis (PPV-MF) or post-essential thrombocythemia-myelofibrosis (PET-MF)
according to the 2008 World Health Organization criteria

- Subjects with myelofibrosis requiring therapy must be classified as high risk OR
intermediate risk level 2 according to the prognostic factors defined by the
International Working Group

- Subjects with an Eastern Cooperative Oncology Group (ECOG) performance status of 0,
1, 2 or 3

- Subjects who have not previously received treatment with a Janus kinase (JAK)

Exclusion Criteria:

- Subjects with a life expectancy of less than 6 months

- Subjects with inadequate bone marrow reserve as demonstrated by specific clinical
laboratory counts

- Subjects with inadequate liver or renal function

- Subjects with clinically significant bacterial, fungal, parasitic or viral infection
which require therapy

- Subjects with an active malignancy over the previous 5 years except specific skin

- Subjects with severe cardiac conditions

- Subjects who have had splenic irradiation within 12 months

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Number of Participants Achieving ≥ 35% Reduction in Spleen Volume From Baseline to Week 24

Outcome Description:

Spleen volume was assessed by magnetic resonance imaging (MRI) or by computed tomograpy (CT) scans if MRI was not suitable, and analyzed by a blinded central laboratory reader. Patients who withdrew, crossed over to ruxolitinib prior to the visit, or had a missing value at the visit were considered non-responders.

Outcome Time Frame:

Baseline and Week 24

Safety Issue:


Principal Investigator

Srdan Verstovsek, MD, PhD

Investigator Role:

Study Director

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Food and Drug Administration

Study ID:

INCB 18424-351



Start Date:

August 2009

Completion Date:

June 2015

Related Keywords:

  • Myelofibrosis
  • Myelofibrosis
  • Post-Polycythemia Vera Myelofibrosis
  • Post-Essential Thrombocythemia Myelofibrosis
  • Primary Myelofibrosis
  • Polycythemia
  • Polycythemia Vera
  • Thrombocythemia, Essential
  • Thrombocytosis



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