Myeloproliferative Neoplasms Clinical Trial
A Study to Evaluate the Efficacy and Safety of Pemigatinib (INCB054828) in Subjects With Myeloid/Lymphoid Neoplasms With FGFR1 Rearrangement – (FIGHT-203)
The purpose of this study is to evaluate the efficacy and safety of pemigatinib (INCB054828) in subjects with myeloid/lymphoid neoplasms with fibroblast growth factor receptor (FGFR) 1 rearrangement.
Documented lymphoid or myeloid neoplasm with 8p11 rearrangement known to lead to FGFR1 activation, based on standard diagnostic cytogenetic evaluation performed locally, before signing informed consent for this study.
Eligible subjects must:
Have relapsed after stem cell transplantation or after other disease modifying therapy, OR
Not be current candidates for stem cell transplantation or other disease modifying therapies.
Note: All relapsed/refractory subjects must have evidence of either cytogenetic or hematological disease and have no evidence of residual toxicity (eg, graft-versus-host disease requiring treatment).
Life expectancy â‰¥ 12 weeks.
Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
Prior receipt of a selective FGFR inhibitor.
History and/or current evidence of ectopic mineralization/calcification, including but not limited to soft tissue, kidneys, intestine, myocardia, or lung, except calcified lymph nodes and asymptomatic arterial or cartilage/tendon calcifications.
Current evidence of corneal disorder/keratopathy, including but not limited to bullous/band keratopathy, corneal abrasion, inflammation/ulceration, and keratoconjunctivitis, as confirmed by ophthalmologic examination.
Use of any potent cytochrome P450 3A4 inhibitors or inducers within 14 days or 5 half-lives (whichever is shorter) before the first dose of study drug.
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There are 33 Locations for this study
Phoenix Arizona, 85054, United States
Duarte California, 91010, United States
Stanford California, 94305, United States
Atlanta Georgia, 30322, United States
Indianapolis Indiana, 46237, United States
Saint Louis Missouri, 63110, United States
New York New York, 10021, United States
Houston Texas, 77030, United States
Salt Lake City Utah, 84112, United States
Linz , 04010, Austria
Wien , 01090, Austria
Wien , 01140, Austria
Leuven , 03000, Belgium
Toronto Ontario, M5G 2, Canada
Lyon , 69373, France
Nice Cedex 3 , 06202, France
Paris Cedex 10 , 75475, France
Toulouse Cedex 9 , 31059, France
Aachen , D-520, Germany
Halle , 06120, Germany
Jena , 07740, Germany
Leipzig , 04103, Germany
Mannheim , 68167, Germany
Minden , 32429, Germany
Bergamo , 24127, Italy
Florence , 50134, Italy
Osaka , 589-8, Japan
Tokyo , 141-8, Japan
Valencia , 46010, Spain
Bern , 03010, Switzerland
Zurich , 08091, Switzerland
London , SE1 9, United Kingdom
Oxford , OX3 7, United Kingdom
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