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Trial record 1 of 1 for:    NCT01348490
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Ruxolitinib (INCB018424) in Subjects With Primary Myelofibrosis, Post Essential Thrombocythemia-myelofibrosis and Post Polycythemia Vera-myelofibrosis

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Incyte Corporation
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation
ClinicalTrials.gov Identifier:
NCT01348490
First received: May 4, 2011
Last updated: August 26, 2014
Last verified: August 2014
  Purpose

To evaluate the effects of treatment with ruxolitinib (INCB018424) on spleen volume, symptoms and potential side effects in patients with PMF, PPV-MF and PET-MF who have platelet counts of 50 x 10^9/L to 100 x 10^9/L. It is anticipated that individualized dose optimization from the starting ruxolitinib level of 5 mg bid will be associated with reductions in splenomegaly, MF-associated symptoms and inflammatory cytokine levels.


Condition Intervention Phase
Primary Myelofibrosis
Post Essential Thrombocythemia-myelofibrosis
Post Polycythemia Vera-myelofibrosis
Drug: Ruxolitinib (INCB018424)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label Assessment of Safety and Efficacy of Ruxolitinib (INCB018424) in Subjects With Primary Myelofibrosis (PMF), Post Essential Thrombocythemia-myelofibrosis (PPV-MF) and Post Polycythemia Vera-myelofibrosis (PET-MF) Who Have Platelet Counts of 50 x 10^9/L to 100 x 10^9/L

Resource links provided by NLM:


Further study details as provided by Incyte Corporation:

Primary Outcome Measures:
  • Measure spleen volume changes in patients with PMF, PPV-MF and PET-MF [ Time Frame: Measured at baseline and Week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Establish adequate dose of INCB018424 in patients with low platelets [ Time Frame: Baseline, every four weeks through Week 24, thereafter every 12 weeks until study completion at week 156. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 150
Study Start Date: June 2011
Estimated Study Completion Date: September 2020
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ruxolitinib (INCB018424) Drug: Ruxolitinib (INCB018424)
Ruxolitinib (INCB018424), 5 mg bid

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed with PMF, PPV-MF or PET-MF as confirmed by bone marrow biopsy
  • Discontinuation of all drugs used to treat underlying MF disease at least 7 days prior to baseline visit
  • INR < 1.5 or PTT value < 1.5 x upper limit of normal (ULN) at study entry
  • Hemoglobin level at least 6.5 g/dL at Screening visit
  • Willingness to be transfused to treat low hemoglobin levels

Exclusion Criteria:

  • Females who are pregnant, unable to comply with birth control use to avoid becoming pregnant or breastfeeding
  • Males who cannot comply with birth control use to avoid fathering a child
  • Platelet count < 50 x10^9/L or absolute neutrophil count (ANC) < 1 x10^9/L at the Screening visit
  • Inadequate liver or renal function; Intracranial bleeds or invasive malignancy over the previous 2 years - international normalized ratio (INR) laboratory values cannot be > 1.5 x upper limit of normal at study entry.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01348490

Contacts
Contact: Incyte Corporation Call Center 1.855.463.3463

  Show 38 Study Locations
Sponsors and Collaborators
Incyte Corporation
Investigators
Study Director: Lance Leopold, MD Incyte Corporation
  More Information

No publications provided by Incyte Corporation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT01348490     History of Changes
Other Study ID Numbers: INCB18424-258
Study First Received: May 4, 2011
Last Updated: August 26, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Incyte Corporation:
PMF
PPV-MF
PET-MF

Additional relevant MeSH terms:
Polycythemia
Polycythemia Vera
Primary Myelofibrosis
Thrombocythemia, Essential
Thrombocytosis
Blood Coagulation Disorders
Blood Platelet Disorders
Bone Marrow Diseases
Hematologic Diseases
Hemorrhagic Disorders
Myeloproliferative Disorders

ClinicalTrials.gov processed this record on November 27, 2014