Trial record 1 of 1 for:    INCB 18424-258
Previous Study | Return to List | Next Study

Ruxolitinib (INCB018424) in Subjects With Primary Myelofibrosis, Post Essential Thrombocythemia-myelofibrosis and Post Polycythemia Vera-myelofibrosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01348490
Recruitment Status : Active, not recruiting
First Posted : May 5, 2011
Last Update Posted : April 4, 2018
Information provided by (Responsible Party):
Incyte Corporation

Brief Summary:
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 or disease Intervention/treatment Phase
MPN (Myeloproliferative Neoplasms) Drug: Ruxolitinib (INCB018424) Phase 2

Access to an investigational treatment associated with this study is available outside the clinical trial.   More info ...

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : June 2011
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : November 2018

Arm Intervention/treatment
Experimental: Ruxolitinib (INCB018424) Drug: Ruxolitinib (INCB018424)
Ruxolitinib (INCB018424), 5 mg bid

Primary Outcome Measures :
  1. Measure spleen volume changes in patients with PMF, PPV-MF and PET-MF [ Time Frame: Measured at baseline and Week 24 ]

Secondary Outcome Measures :
  1. 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. ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01348490

  Hide Study Locations
United States, Alabama
Birmingham, Alabama, United States
United States, California
Beverly Hills, California, United States
Burbank, California, United States
La Jolla, California, United States
Los Angeles, California, United States
Pomona, California, United States
San Diego, California, United States
United States, Connecticut
New Haven, Connecticut, United States
United States, Florida
Fort Myers, Florida, United States
Jacksonville, Florida, United States
Orange City, Florida, United States
United States, Georgia
Atlanta, Georgia, United States
Augusta, Georgia, United States
United States, Illinois
Chicago, Illinois, United States
United States, Iowa
Iowa City, Iowa, United States
United States, Kentucky
Louisville, Kentucky, United States
United States, Louisiana
New Orleans, Louisiana, United States
United States, Maryland
Baltimore, Maryland, United States
United States, Michigan
Ann Arbor, Michigan, United States
Southfield, Michigan, United States
United States, Missouri
Saint Louis, Missouri, United States
United States, New Jersey
Hackensack, New Jersey, United States
Morristown, New Jersey, United States
Somerville, New Jersey, United States
United States, New York
New York, New York, United States
United States, North Carolina
Durham, North Carolina, United States
Hickory, North Carolina, United States
United States, Ohio
Canton, Ohio, United States
Cleveland, Ohio, United States
United States, Oregon
Portland, Oregon, United States
United States, Pennsylvania
Danville, Pennsylvania, United States
Hershey, Pennsylvania, United States
United States, South Carolina
Charleston, South Carolina, United States
United States, Tennessee
Nashville, Tennessee, United States
United States, Texas
Houston, Texas, United States
San Antonio, Texas, United States
United States, Utah
Salt Lake City, Utah, United States
United States, Vermont
Burlington, Vermont, United States
Sponsors and Collaborators
Incyte Corporation
Study Director: Peter Langmuir, MD Incyte Corporation

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Incyte Corporation Identifier: NCT01348490     History of Changes
Other Study ID Numbers: INCB18424-258
First Posted: May 5, 2011    Key Record Dates
Last Update Posted: April 4, 2018
Last Verified: April 2018

Keywords provided by Incyte Corporation:

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