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

Stopped early · Phase 2

Conditions studied: MPN (Myeloproliferative Neoplasms)

In brief

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

Key facts

Study ID

NCT02718300

Run by

Incyte Corporation

People needed

74

Starts

2017-02-08

Expected to finish

2022-04-29

Last updated by the study team

2024-05-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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