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A Study of INCB050465 in Combination With Ruxolitinib in Subjects With 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02718300
Recruitment Status : Recruiting
First Posted : March 24, 2016
Last Update Posted : September 13, 2019
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

Tracking Information
First Submitted Date  ICMJE March 21, 2016
First Posted Date  ICMJE March 24, 2016
Last Update Posted Date September 13, 2019
Study Start Date  ICMJE June 2016
Estimated Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 7, 2018)
  • Part 1: Number of Participants With Dose Limiting Toxicities (DLTs) [ Time Frame: Baseline to Day 28 ]
  • Part 2, Part 3 and Part 4: Change From Baseline in Spleen Volume at Week 12 as measured by MRI or CT scan [ Time Frame: Baseline to Week 12 ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 23, 2016)
  • 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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 23, 2016)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of INCB050465 in Combination With Ruxolitinib in Subjects With Myelofibrosis
Official Title  ICMJE A Phase 2 Study of the Safety, Tolerability, and Efficacy of INCB050465 in Combination With Ruxolitinib in Subjects With Myelofibrosis
Brief Summary The purpose of this study is to evaluate the safety, tolerability, and efficacy of the combination of parsaclisib and ruxolitinib in subjects with myelofibrosis.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE MPN (Myeloproliferative Neoplasms)
Intervention  ICMJE
  • Drug: Parsaclisib
    Up to 3 oral once a day (QD) doses of parsaclisib. Doses will be taken once daily for 8 weeks, followed by once weekly dosing at the same dose level.
    Other Name: INCB050465
  • Drug: Parsaclisib
    Two recommended oral QD doses of parsaclisib. Once daily doses of parsaclisib will be taken for 8 weeks, followed by once weekly dosing at the same dose level.
    Other Name: INCB050465
  • 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 parsaclisib.
    Other Name: Jakafi®
  • Drug: Parsaclisib
    20 mg oral QD dose of parsaclisib for 8 weeks. After 8 weeks patients will take either 20 mg once weekly or 5 mg once daily.
    Other Name: INCB050465
  • Drug: Parsaclisib

    2 dose strategies will be compared:

    1. 5 mg parsaclisib beginning on Day 1 until end of treatment.
    2. 20 mg oral QD dose of parsaclisib for 8 weeks; after 8 weeks patients will take 5 mg once daily.
    Other Name: INCB050465
Study Arms  ICMJE
  • Experimental: Part 1: Ruxolitinib + Parsaclisib
    Initial cohort dose of parsaclisib added to existing stable regimen of ruxolitinib, with subsequent cohort escalations based on protocol-specific criteria.
    Interventions:
    • Drug: Parsaclisib
    • Drug: Ruxolitinib
  • Experimental: Part 2: Ruxolitinib + Parsaclisib
    Part 2 will compare 2 doses of parsaclisib .
    Interventions:
    • Drug: Parsaclisib
    • Drug: Ruxolitinib
  • Experimental: Part 3: Ruxolitinib + Parsaclisib
    Part 3 will compare 2 different long term dosing strategies.
    Interventions:
    • Drug: Ruxolitinib
    • Drug: Parsaclisib
  • Experimental: Part 4: Ruxolitinib + Parsaclisib
    Part 4 will compare 2 different daily dosing strategies.
    Interventions:
    • Drug: Ruxolitinib
    • Drug: Parsaclisib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 7, 2018)
90
Original Estimated Enrollment  ICMJE
 (submitted: March 23, 2016)
78
Estimated Study Completion Date  ICMJE January 2021
Estimated Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Incyte Corporation Call Center 1.855.463.3463
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02718300
Other Study ID Numbers  ICMJE INCB 50465-201
Parsaclisib ( Other Identifier: Incyte Corporation )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Incyte Corporation
Study Sponsor  ICMJE Incyte Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Albert Assad, MD Incyte Corporation
PRS Account Incyte Corporation
Verification Date September 2019

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