Myeloproliferative Neoplasms Clinical Trial

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

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.

View Eligibility Criteria

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

Study is for people with:

Myeloproliferative Neoplasms

Phase:

Phase 2

Estimated Enrollment:

74

Study ID:

NCT02718300

Recruitment Status:

Terminated

Sponsor:

Incyte Corporation

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 39 Locations for this study

See Locations Near You

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

How clear is this clinincal trial information?

Study is for people with:

Myeloproliferative Neoplasms

Phase:

Phase 2

Estimated Enrollment:

74

Study ID:

NCT02718300

Recruitment Status:

Terminated

Sponsor:


Incyte Corporation

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.