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A Study of INCB050465 in Combination With Ruxolitinib in Subjects With Myelofibrosis

This study is currently recruiting participants.
Verified July 2017 by Incyte Corporation
Sponsor:
ClinicalTrials.gov Identifier:
NCT02718300
First Posted: March 24, 2016
Last Update Posted: July 28, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Incyte Corporation
March 21, 2016
March 24, 2016
July 28, 2017
June 2016
September 2018   (Final data collection date for primary outcome measure)
  • Part 1: Number of Participants With Dose Limiting Toxicities (DLTs) [ Time Frame: Baseline to Day 28 ]
  • Part 2: Change From Baseline in Spleen Volume at Week 12 as measured by MRI or CT scan [ Time Frame: Baseline to Week 12 ]
Same as current
Complete list of historical versions of study NCT02718300 on ClinicalTrials.gov Archive Site
  • Number of subjects with adverse events (AEs) and changes in vital signs, ECGs, and laboratory parameters [ Time Frame: Screening through up to 30 days after last dose of study drug, up to 25 months ]
  • Change in total symptom score as measured by patient-reported myelofibrosis symptoms [ Time Frame: Baseline through Week 12 or Week 24 ]
  • Change From Baseline in Spleen Volume at Week 24 as measured by MRI or CT scan [ Time Frame: Baseline to Week 24 ]
Same as current
Not Provided
Not Provided
 
A Study of INCB050465 in Combination With Ruxolitinib in Subjects With Myelofibrosis
A Phase 2 Study of the Safety, Tolerability, and Efficacy of INCB050465 in Combination With Ruxolitinib in Subjects With Myelofibrosis
The purpose of this study is to evaluate the safety, tolerability, and efficacy of the combination of INCB050465 and ruxolitinib in subjects with myelofibrosis.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Myelofibrosis
  • Drug: INCB050465
    Up to 3 oral once a day (QD) doses of INCB050465. Doses will be taken once daily for 8 weeks, followed by once weekly dosing at the same dose level.
  • Drug: INCB050465
    Two recommended oral QD doses of INCB050465. Once daily doses of INCB050465 will be taken for 8 weeks, followed by once weekly dosing at the same dose level.
  • Drug: Ruxolitinib
    The dose of ruxolitinib will be that which the subjects had been taking for at least 8 weeks before the first dose of INCB050465.
    Other Name: Jakafi®
  • Experimental: Part 1: Ruxolitinib + INCB050465
    Initial cohort dose of INCB050465 added to existing stable regimen of ruxolitinib, with subsequent cohort escalations based on protocol-specific criteria.
    Interventions:
    • Drug: INCB050465
    • Drug: Ruxolitinib
  • Experimental: Part 2: Ruxolitinib + INCB050465
    Part 2 will compare 2 doses of INCB050465
    Interventions:
    • Drug: INCB050465
    • Drug: Ruxolitinib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
78
June 2019
September 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of primary myelofibrosis, post-polycythemia vera myelofibrosis, or post-essential thrombocythemia myelofibrosis
  • Palpable spleen of > 10 cm below the left subcostal margin on physical examination at the screening visit OR
  • Palpable splenomegaly of 5 to 10 cm below left subcostal margin on physical exam AND active symptoms of MF at the screening visit as demonstrated by presence of 1 symptom score ≥ 5 or 2 symptom scores ≥ 3 using the Screening Symptom Form
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2

Exclusion Criteria:

  • Use of experimental drug therapy for myelofibrosis, or any other standard drug (eg, danazol, hydroxyurea, etc) with the exception of ruxolitinib within 6 months of starting study (combination) therapy and/or lack of recovery from all toxicities from previous therapy (except ruxolitinib) to Grade 1 or better
  • Inability to swallow food or any condition of the upper gastrointestinal tract that precludes administration of oral medications
  • Unwillingness to be transfused with blood components
  • Recent history of inadequate bone marrow reserve as demonstrated by the following:

    • Platelet count < 50 × 10^9/L in the 4 weeks before screening or platelet transfusion(s) within 8 weeks before screening
    • Absolute neutrophil count levels < 0.5 × 10^9/L in the 4 weeks before screening
    • Subjects with peripheral blood blast count of > 10% at the screening or baseline hematology assessments
    • Subjects who are not willing to receive red blood cell (RBC) transfusions to treat low hemoglobin levels
  • Inadequate liver function at screening as demonstrated by the following:

    • Direct bilirubin ≥ 2.0 × the upper limit of laboratory normal (ULN). (NOTE: direct bilirubin will only be determined if total bilirubin is ≥ 2.0 × ULN)
    • alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.5 × ULN
  • Inadequate renal function at screening as demonstrated by creatinine clearance < 50 mL/min or glomerular filtration rate < 50 mL/min/1.73 m^2
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Incyte Corporation Call Center 1.855.463.3463
United States
 
 
NCT02718300
INCB 50465-201
No
Not Provided
Not Provided
Incyte Corporation
Incyte Corporation
Not Provided
Study Director: Albert Assad, MD Incyte Corporation
Incyte Corporation
July 2017

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