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

Status: Active

Description

The purpose of this study is to evaluate the safety, tolerability, and efficacy of the combination of parsaclisib and ruxolitinib in subjects with myelofibrosis.

Eligibility Criteria

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

Locations & Contacts

California

Duarte
City of Hope Comprehensive Cancer Center
Status: Active
Name Not Available
Los Angeles
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: Active
Name Not Available

Georgia

Atlanta
Emory University Hospital / Winship Cancer Institute
Status: Active
Name Not Available

Illinois

Chicago
University of Chicago Comprehensive Cancer Center
Status: Active
Contact: Olatoyosi Muinat Odenike
Email: todenike@medicine.bsd.uchicago.edu

Kansas

Kansas City
University of Kansas Cancer Center
Status: Active
Name Not Available
Westwood
University of Kansas Hospital-Westwood Cancer Center
Status: Active
Name Not Available

Massachusetts

Boston
Brigham and Women's Hospital
Status: Approved
Name Not Available
Dana-Farber Cancer Institute
Status: Approved
Name Not Available
Massachusetts General Hospital Cancer Center
Status: Active
Name Not Available

Missouri

Saint Louis
Siteman Cancer Center at Washington University
Status: Active
Name Not Available

New York

Bronx
Montefiore Medical Center-Einstein Campus
Status: Active
Name Not Available
Buffalo
Roswell Park Cancer Institute
Status: Active
Name Not Available
New York
Icahn School of Medicine at Mount Sinai
Status: Active
Name Not Available
Memorial Sloan Kettering Cancer Center
Status: Active
Contact: Raajit Kumar Rampal
Phone: 212-639-2194
Email: rampalr@mskcc.org
NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center
Status: Active
Name Not Available

Ohio

Cleveland
Case Comprehensive Cancer Center
Status: Active
Name Not Available

Oregon

Portland
OHSU Knight Cancer Institute
Status: Active
Name Not Available

Texas

Houston
M D Anderson Cancer Center
Status: Active
Name Not Available

Trial Phase & Type

Trial Phase

Phase II

Trial Type

Treatment

Lead Organization

Lead Organization
Incyte Corporation

Trial IDs

Primary ID INCB 50465-201
Secondary IDs NCI-2016-01146, Parsaclisib
Clinicaltrials.gov ID NCT02718300