ClinicalTrials.gov
ClinicalTrials.gov Menu
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.
ClinicalTrials.gov Identifier: NCT01348490
Recruitment Status : Active, not recruiting
First Posted : May 5, 2011
Last Update Posted : April 4, 2018
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

May 4, 2011
May 5, 2011
April 4, 2018
June 2011
November 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 ]
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. ]
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 ]
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
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
MPN (Myeloproliferative Neoplasms)
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.
 
Active, not recruiting
66
150
November 2018
November 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 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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01348490
INCB18424-258
Yes
Not Provided
Not Provided
Incyte Corporation
Incyte Corporation
Not Provided
Study Director: Peter Langmuir, MD Incyte Corporation
Incyte Corporation
April 2018

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