A Study of INCB050465 in Combination With Ruxolitinib in Subjects With Myelofibrosis
Trial Status: Active
The purpose of this study is to evaluate the safety, tolerability, and efficacy of the combination of parsaclisib and ruxolitinib in subjects with myelofibrosis.
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
Arizona
Phoenix
Mayo Clinic Hospital in Arizona
Status: CLOSED_TO_ACCRUAL
Scottsdale
Mayo Clinic in Arizona
Status: CLOSED_TO_ACCRUAL
California
Duarte
City of Hope Comprehensive Cancer Center
Status: ACTIVE
Los Angeles
Los Angeles County-USC Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Christine Duran
Phone: 323-865-0371
Email:
marquezc@usc.edu
UCLA / Jonsson Comprehensive Cancer Center
Status: ACTIVE
Contact: Vlad Kustanovich
Phone: 310-206-5755
Email:
VKustanovich@mednet.ucla.edu
USC / Norris Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Georgia
Atlanta
Emory University Hospital / Winship Cancer Institute
Status: ACTIVE
Illinois
Chicago
University of Chicago Comprehensive Cancer Center
Status: ACTIVE
Contact: Olatoyosi Muinat Odenike
Kansas
Kansas City
University of Kansas Cancer Center
Status: ACTIVE
Westwood
University of Kansas Hospital-Westwood Cancer Center
Status: ACTIVE
Massachusetts
Boston
Brigham and Women's Hospital
Status: APPROVED
Dana-Farber Cancer Institute
Status: APPROVED
Massachusetts General Hospital Cancer Center
Status: ACTIVE
Missouri
Saint Louis
Siteman Cancer Center at Washington University
Status: CLOSED_TO_ACCRUAL
New Jersey
Hackensack
Hackensack University Medical Center
Status: ACTIVE
New York
Bronx
Montefiore Medical Center-Einstein Campus
Status: ACTIVE
Buffalo
Roswell Park Cancer Institute
Status: ACTIVE
New York
Icahn School of Medicine at Mount Sinai
Status: ACTIVE
Memorial Sloan Kettering Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Raajit Kumar Rampal
Phone: 212-639-2194
Email:
rampalr@mskcc.org
NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center
Status: ACTIVE
Ohio
Cleveland
Case Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Oregon
Portland
OHSU Knight Cancer Institute
Status: CLOSED_TO_ACCRUAL
Texas
Houston
M D Anderson Cancer Center
Status: ACTIVE
Utah
Salt Lake City
Huntsman Cancer Institute / University of Utah
Status: ADMINISTRATIVELY_COMPLETE
Trial Phase Phase II
Trial Type Treatment
Lead Organization
Incyte Corporation
- Primary ID INCB 50465-201
- Secondary IDs NCI-2016-01146, Parsaclisib
- Clinicaltrials.gov ID NCT02718300