A Study of INCB050465 in Combination With Ruxolitinib in Subjects With Myelofibrosis
NCT ID: NCT02718300
Last Updated: 2024-05-01
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
74 participants
INTERVENTIONAL
2017-02-08
2022-04-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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.
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.
Part 2: Ruxolitinib + Parsaclisib
Part 2 will compare 2 doses of parsaclisib .
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.
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.
Part 3: Ruxolitinib + Parsaclisib
Part 3 will compare 2 different long term dosing strategies.
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.
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.
Part 4: Ruxolitinib + Parsaclisib
Part 4 will compare 2 different daily dosing strategies.
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.
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.
Interventions
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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.
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.
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.
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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Incyte Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Albert Assad, MD
Role: STUDY_DIRECTOR
Incyte Corporation
Locations
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Birmingham Hematology & Oncolgy Associates Llc
Birmingham, Alabama, United States
Mayo Clinic Arizona
Scottsdale, Arizona, United States
Alta Bates Medical Center
Berkeley, California, United States
City of Hope National Medical Center
Duarte, California, United States
California Cancer Associates For Research and Excellence
Fresno, California, United States
University of Southern California
Los Angeles, California, United States
UCLA School of Medicine
Los Angeles, California, United States
Pcr Oncology
Pismo Beach, California, United States
California Cancer Assoc. for Research and Excellence
San Marcos, California, United States
Georgetown University Hospital
Washington D.C., District of Columbia, United States
Shands Hospital
Gainesville, Florida, United States
Emory University
Atlanta, Georgia, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Indiana Blood and Marrow Transplantation
Indianapolis, Indiana, United States
McFarland Clinic
Ames, Iowa, United States
University of Kansas Cancer Center
Westwood, Kansas, United States
Norton Cancer Institute
Louisville, Kentucky, United States
Saint Agnes Hospital
Baltimore, Maryland, United States
Cancer Center For Blood Disorders
Bethesda, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Washington University School of Medicine
St Louis, Missouri, United States
Summit Medical Group
Florham Park, New Jersey, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
New Mexico Cancer Care Alliance
Albuquerque, New Mexico, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Mount Sinai School of Medicine
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Oncology Hematology Care, Inc.
Cincinnati, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Oregon Health & Science University
Portland, Oregon, United States
Rush University Medical Center
Nashville, Tennessee, United States
Baylor Scott and White Research Institute
Dallas, Texas, United States
Md Anderson Cancer Center
Houston, Texas, United States
Cancer Care Centers of South Texas
San Antonio, Texas, United States
Renovatio Clinical Consultants Llc
The Woodlands, Texas, United States
Va Salt Lake City Health Care System
Salt Lake City, Utah, United States
Vista Oncology Inc Ps
Olympia, Washington, United States
Countries
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References
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Yacoub A, Borate U, Rampal RK, Ali H, Wang ES, Gerds AT, Hobbs G, Kremyanskaya M, Winton E, O'Connell C, Goel S, Oh ST, Schiller G, McCloskey J, Palmer J, Holmes H, Hager S, Assad A, Erickson-Viitanen S, Zhou F, Daver N. Phase 2 study of add-on parsaclisib for patients with myelofibrosis and suboptimal response to ruxolitinib: final results. Blood Adv. 2024 Mar 26;8(6):1515-1528. doi: 10.1182/bloodadvances.2023011620.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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Parsaclisib
Identifier Type: OTHER
Identifier Source: secondary_id
INCB 50465-201
Identifier Type: -
Identifier Source: org_study_id
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