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

Sponsor
Incyte Corporation (Industry)
Overall Status
Completed
CT.gov ID
NCT02718300
Collaborator
(none)
74
Enrollment
39
Locations
4
Arms
62.6
Actual Duration (Months)
1.9
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
74 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 2 Study of the Safety, Tolerability, and Efficacy of INCB050465 in Combination With Ruxolitinib in Subjects With Myelofibrosis
Actual Study Start Date :
Feb 8, 2017
Actual Primary Completion Date :
Jan 28, 2021
Actual Study Completion Date :
Apr 29, 2022

Arms and Interventions

Arm Intervention/Treatment
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.

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 Names:
  • 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 Names:
  • Jakafi®

    		•
    Experimental: Part 2: Ruxolitinib + Parsaclisib

    Part 2 will compare 2 doses of parsaclisib .

    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 Names:
  • 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 Names:
  • Jakafi®

    		•
    Experimental: Part 3: Ruxolitinib + Parsaclisib

    Part 3 will compare 2 different long term dosing strategies.

    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 Names:
  • 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 Names:
  • INCB050465

    		•
    Experimental: Part 4: Ruxolitinib + Parsaclisib

    Part 4 will compare 2 different daily dosing strategies.

    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 Names:
  • Jakafi®

    • Drug: Parsaclisib
    2 dose strategies will be compared: 5 mg parsaclisib beginning on Day 1 until end of treatment. 20 mg oral QD dose of parsaclisib for 8 weeks; after 8 weeks patients will take 5 mg once daily.
    Other Names:
  • INCB050465

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Part 1: Number of Participants With Dose Limiting Toxicities (DLTs) [Baseline to Day 28]

    2. Part 2, Part 3 and Part 4: Change From Baseline in Spleen Volume at Week 12 as measured by MRI or CT scan [Baseline to Week 12]

    Secondary Outcome Measures

    1. Number of subjects with adverse events (AEs) and changes in vital signs, ECGs, and laboratory parameters [Screening through up to 30 days after last dose of study drug, up to 25 months]

    2. Change in total symptom score as measured by patient-reported myelofibrosis symptoms [Baseline through Week 12 or Week 24]

    3. Change From Baseline in Spleen Volume at Week 24 as measured by MRI or CT scan [Baseline to Week 24]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Birmingham Hematology & Oncolgy Associates Llc Birmingham Alabama United States 35223
    2 Mayo Clinic Arizona Scottsdale Arizona United States 85259
    3 Alta Bates Medical Center Berkeley California United States 94704
    4 City of Hope National Medical Center Duarte California United States 91010
    5 California Cancer Associates For Research and Excellence Fresno California United States 93720
    6 University of Southern California Los Angeles California United States 90033
    7 UCLA School of Medicine Los Angeles California United States 90095
    8 Pcr Oncology Pismo Beach California United States 93449
    9 California Cancer Assoc. for Research and Excellence San Marcos California United States 92069
    10 Georgetown University Hospital Washington District of Columbia United States 20007
    11 Shands Hospital Gainesville Florida United States 32610
    12 Emory University Atlanta Georgia United States 30322
    13 University of Chicago Medical Center Chicago Illinois United States 60637
    14 Indiana Blood and Marrow Transplantation Indianapolis Indiana United States 46237
    15 McFarland Clinic Ames Iowa United States 50010
    16 University of Kansas Cancer Center Westwood Kansas United States 66205
    17 Norton Cancer Institute Louisville Kentucky United States 40202
    18 Saint Agnes Hospital Baltimore Maryland United States 21229
    19 Cancer Center For Blood Disorders Bethesda Maryland United States 20817
    20 Massachusetts General Hospital Boston Massachusetts United States 02114
    21 Washington University School of Medicine Saint Louis Missouri United States 63130
    22 Summit Medical Group Florham Park New Jersey United States 07932
    23 Hackensack University Medical Center Hackensack New Jersey United States 07601
    24 New Mexico Cancer Care Alliance Albuquerque New Mexico United States 87106
    25 Montefiore Medical Center Bronx New York United States 10467
    26 Roswell Park Cancer Institute Buffalo New York United States 14263
    27 Mount Sinai School of Medicine New York New York United States 10029
    28 Columbia University Medical Center New York New York United States 10032
    29 Memorial Sloan Kettering Cancer Center New York New York United States 10065
    30 Oncology Hematology Care, Inc. Cincinnati Ohio United States 45230
    31 Cleveland Clinic Cleveland Ohio United States 44195
    32 Oregon Health & Science University Portland Oregon United States 97239
    33 Rush University Medical Center Nashville Tennessee United States 37203
    34 Baylor Scott and White Research Institute Dallas Texas United States 75246
    35 Md Anderson Cancer Center Houston Texas United States 77030
    36 Cancer Care Centers of South Texas San Antonio Texas United States 78217
    37 Renovatio Clinical Consultants Llc The Woodlands Texas United States 77380
    38 Va Salt Lake City Health Care System Salt Lake City Utah United States 84112
    39 Vista Oncology Inc Ps Olympia Washington United States 98506

    Sponsors and Collaborators

    • Incyte Corporation

    Investigators

    • Study Director: Albert Assad, MD, Incyte Corporation

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Incyte Corporation
    ClinicalTrials.gov Identifier:
    NCT02718300
    Other Study ID Numbers:
    • INCB 50465-201
    • Parsaclisib
    First Posted:
    Mar 24, 2016
    Last Update Posted:
    Jun 6, 2022
    Last Verified:
    Jun 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Incyte Corporation
    Primary myelofibrosis (PMF)
    post-polycythemia vera myelofibrosis (PPV-MF)
    post-essential thrombocythemia myelofibrosis (PET-MF)
    myeloproliferative neoplasms (MPNs)
    phosphoinositide 3-kinase (PI3K) inhibitor
    Janus kinase (JAK) inhibitor
    Additional relevant MeSH terms:
    Primary Myelofibrosis
    Myeloproliferative Disorders

    Study Results

    No Results Posted as of Jun 6, 2022