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 February 2014 by Incyte Corporation
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation
ClinicalTrials.gov Identifier:
NCT01348490
First received: May 4, 2011
Last updated: February 7, 2014
Last verified: February 2014

May 4, 2011
February 7, 2014
June 2011
February 2018   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01348490 on ClinicalTrials.gov Archive Site
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 ]
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 ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Ruxolitinib (INCB018424) in Subjects With Primary Myelofibrosis, Post Essential Thrombocythemia-myelofibrosis and Post Polycythemia Vera-myelofibrosis
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

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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Primary Myelofibrosis
  • Post Essential Thrombocythemia-myelofibrosis
  • Post Polycythemia Vera-myelofibrosis
Drug: Ruxolitinib (INCB018424)
Ruxolitinib (INCB018424), 5 mg bid
Experimental: Ruxolitinib (INCB018424)
Intervention: Drug: Ruxolitinib (INCB018424)
Talpaz M, Paquette R, Afrin L, Hamburg SI, Prchal JT, Jamieson K, Terebelo HR, Ortega GL, Lyons RM, Tiu RV, Winton EF, Natrajan K, Odenike O, Claxton D, Peng W, O'Neill P, Erickson-Viitanen S, Leopold L, Sandor V, Levy RS, Kantarjian HM, Verstovsek S. Interim analysis of safety and efficacy of ruxolitinib in patients with myelofibrosis and low platelet counts. J Hematol Oncol. 2013 Oct 29;6(1):81. doi: 10.1186/1756-8722-6-81.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
September 2020
February 2018   (final data collection date for primary outcome measure)

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 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 ANC < 1 x10^9/L at the Screening visit
  • Inadequate liver or renal function; Intracranial bleeds or invasive malignancy over the previous 2 years - INR laboratory values cannot be > 1.5 x upper limit of normal at study entry.
Both
18 Years and older
No
Contact: Incyte Corporation Call Center 1.855.463.3463
United States
 
NCT01348490
INCB18424-258
Yes
Incyte Corporation
Incyte Corporation
Not Provided
Study Director: Lance Leopold, 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