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: March 3, 2014
Last verified: February 2014

September 23, 2011
March 3, 2014
September 2011
March 2013   (final data collection date for primary outcome measure)
Mean % change in spleen volume as measured by MRI [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: No ]
Mean % change in spleen volume as measured by MRI [ Time Frame: Baseline and 24 Weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01445769 on ClinicalTrials.gov Archive Site
  • Assessment of safety and tolerability [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: Yes ]
  • Mean % change in Total Symptom Score as measured by the modified MFSAF v2.0 diary at Week 24 compared to Baseline [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: No ]
  • Proportion of subjects with ≥ 35% reduction in spleen volume at Week 24 compared to Baseline [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: No ]
  • 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 ]
Not Provided
Not Provided
 
Alternative Dosing Strategy of Ruxolitinib in Patients With Myelofibrosis
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

The purpose of this study was to evaluate the effect of an alternative dosing strategy of ruxolitinib in subjects with primary myelofibrosis (PMF), post-polycythemia vera-myelofibrosis (PPV-MF) and post essential thrombocythemia-myelofibrosis (PET-MF).

This study was designed to explore a new dosing approach. Subjects began dosing at 10 mg bid and had the opportunity for dose increases based on assessments of efficacy and overall anemia status in a defined prior dosing interval. The dose could 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 were described to minimize excursions of hemoglobin levels into the Grade 3 or Grade 4 range.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Primary Myelofibrosis
  • Post-Polycythemia Vera Myelofibrosis
  • Post-Essential Thrombocythemia Myelofibrosis
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
  • INC424
Experimental: Ruxolitinib
Intervention: Drug: Ruxolitinib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
45
April 2013
March 2013   (final data collection date for primary outcome measure)

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 Dynamic International Prognostic Scoring System (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 myelofibrosis (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*10^9/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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01445769
18424-261
No
Incyte Corporation
Incyte Corporation
Not Provided
Study Director: William V Williams, MD Incyte Corporation
Incyte Corporation
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP