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Alternative Dosing Strategy of Ruxolitinib in Patients With Myelofibrosis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation
ClinicalTrials.gov Identifier:
NCT01445769
First received: September 23, 2011
Last updated: May 13, 2013
Last verified: May 2013
History of Changes
  Purpose

To evaluate the effect of an alternative dosing strategy of ruxolitinib on spleen volume in subjects with primary myelofibrosis (PMF), post-polycythemia vera-myelofibrosis (PPV-MF) and post essential thrombocythemia-myelofibrosis (PET-MF).


Condition Intervention Phase
Primary Myelofibrosis
Polycythemia Vera, Post-Polycythemic Myelofibrosis
 Drug: Ruxolitinib
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label Assessment of an Alternative Dosing Strategy of Ruxolitinib in Patients With Primary Myelofibrosis, Post-Polycythemia Vera-Myelofibrosis and Post-Essential Thrombocythemia-Myelofibrosis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Incyte Corporation:

Primary Outcome Measures:
  • Mean % change in spleen volume as measured by MRI [ Time Frame: Baseline and 24 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assessment of safety and tolerability [ Time Frame: At each study visit up to 24 weeks. ] [ Designated as safety issue: Yes ]
    Monitor frequency, duration and severity of adverse events, perform physical examinations, collect vital signs and clinical laboratory data.

  • Mean % change in Total Symptom Score as measured by the modified MFSAF v2.0 diary at Week 24 compared to Baseline [ Time Frame: Baseline and Week 24 study visits ] [ Designated as safety issue: No ]
  • Proportion of subjects with ≥ 35% reduction in spleen volume at Week 24 compared to Baseline [ Time Frame: Baseline and Week 24 study visits ] [ Designated as safety issue: No ]

Enrollment: 45
Study Start Date: August 2011
Study Completion Date: April 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ruxolitinib Drug: Ruxolitinib
Initial starting dose - 10mg bid Maximum dose - 20mg bid Dose may be increased at pre-specified intervals based on evaluation of safety and efficacy parameters
Other Names:
  • INCB018424
  • INCB 18424

Detailed Description:

This study is designed to explore a new dosing approach. Subjects will begin dosing at 10 mg bid and will have opportunity for dose increases based on assessment of efficacy and overall anemia status in a defined prior dosing interval. The dose may be increased up to a maximum dose of 20 mg bid. This approach assumes that beginning at a low dose for initial therapy may impact the rate of the initial hemoglobin decline and the nadir, by decreasing the level of JAK-mediated inhibition of hematopoiesis. Specific dose modifications are described to minimize excursions of hemoglobin levels into the Grade 3 or Grade 4 range.

  Eligibility

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

Inclusion Criteria:

  • Diagnosis of Primary Myelofibrosis (PMF), Post Polycythemia Vera Myelofibrosis (PPV-MF), or Post Essential Thrombocythemia Myelofibrosis (PET-MF) as confirmed by bone marrow biopsy.
  • Must score at least 2 points on the DIPSS scale for prognostic risk factors
  • Peripheral blast count < 5% at both Screening and Baseline hematology assessments.
  • Must discontinue all drugs used to treat underlying MF disease no later than Day -1 (the day prior to starting ruxolitinib).
  • Must have hemoglobin value ≥ 6.5 g/dL and be willing to receive blood transfusions.
  • Platelet count ≥ 100 x10^9/L.
  • Must have a palpable spleen.

Exclusion Criteria:

  • Inadequate liver or bone marrow reserves, end stage renal disease on dialysis, clinically significant concurrent infections requiring therapy, or unstable cardiac function.
  • Invasive malignancies over the previous 5 years (except treated early stage carcinomas of the skin, completely resected intraepithelial carcinoma of the cervix and completely resected papillary thyroid and follicular thyroid cancers.)
  • Splenic irradiation within 6 months prior to receiving the first dose of study medication.
  • Life expectancy less than 6 months.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01445769

Locations
United States, California
Highland, California, United States
La Jolla, California, United States
Los Angeles, California, United States
United States, Florida
Jacksonville, Florida, United States
Orange City, Florida, United States
Winter Park, Florida, United States
United States, Georgia
Atlanta, Georgia, United States
Augusta, Georgia, United States
United States, Iowa
Iowa City, Iowa, United States
United States, Maryland
Baltimore, Maryland, United States
United States, Michigan
Ann Arbor, Michigan, United States
Southfield, Michigan, United States
United States, New Jersey
Morristown, New Jersey, United States
United States, New York
Armonk, New York, United States
United States, North Carolina
Hickory, North Carolina, United States
United States, Ohio
Canton, Ohio, United States
United States, Pennsylvania
Hazelton, Pennsylvania, United States
Hershey, Pennsylvania, United States
United States, South Carolina
Charleston, South Carolina, United States
United States, South Dakota
Sioux Falls, South Dakota, United States
United States, Texas
San Antonio, Texas, United States
Sponsors and Collaborators
Incyte Corporation
Investigators
Study Director: William V Williams, MD Incyte Corporation
  More Information

No publications provided

Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT01445769     History of Changes
Other Study ID Numbers: 18424-261
Study First Received: September 23, 2011
Last Updated: May 13, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Incyte Corporation:
Myelofibrosis
Primary Myelofibrosis
Post Polycythemia Vera Myelofibrosis
Post Essential Thrombocythemia Myelofibrosis
PMF
PPV-MF
 PET-MF
Open label
Ruxolitinib
18424
Jak inhibitor

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

ClinicalTrials.gov processed this record on May 21, 2013