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



Status:Recruiting
Conditions:Hematology
Therapuetic Areas:Hematology
Healthy:No
Age Range:18 - Any
Updated:3/23/2019
Start Date:June 2016
End Date:October 2021
Contact:Incyte Corporation Call Center
Phone:1.855.463.3463

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A Phase 2 Study of the Safety, Tolerability, and Efficacy of Parsaclisib in Combination With Ruxolitinib in Subjects With Myelofibrosis

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
We found this trial at
24
sites
666 Elm Street
Buffalo, New York 14263
(716) 845-2300
Phone: 716-845-1205
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Phone: 404-778-1900
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Phone: 617-724-1124
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
Phone: 773-702-2084
University of Chicago One of the world's premier academic and research institutions, the University of...
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Phone: 503-346-0227
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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Baltimore, Maryland 21229
Phone: 410-368-2966
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500 Office Park Drive
Birmingham, Alabama 35223
Phone: 205-599-4929
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60 East 208th Street
Bronx, New York 10467
Phone: 718-920-4137
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10550 Montgomery Rd # 22
Cincinnati, Ohio 45242
Phone: 313-731-2273
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Phone: 216-445-9840
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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Duarte, California 91010
Phone: 626-256-4673
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30 Prospect Ave
Hackensack, New Jersey 07601
(201) 996-2000
Phone: 551-996-3925
Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
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Houston, Texas 77030
Phone: 713-794-4392
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Indianapolis, Indiana 46237
Phone: 317-528-5500
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Kerrville, Texas 78028
Phone: 210-595-5300
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Los Angeles, California 90008
Phone: 323-865-3577
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Los Angeles, California 90025
Phone: 310-794-0242
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676 South Floyd Street
Louisville, Kentucky 40202
Phone: 502-629-6068
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Morristown, New Jersey 07960
Phone: 973-476-1755
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New York, New York 10029
Phone: 212-241-4106
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205 East 64th Street
New York, New York 10065
Phone: 646-888-1042
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630 W 168th St
New York, New York
212-305-2862
Phone: 646-317-5199
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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Saint Louis, Missouri 63110
Phone: 314-362-8846
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Westwood, Kansas 66205
Phone: 913-945-5793
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