A Study to Evaluate the Efficacy and Safety of Pemigatinib (INCB054828) in Subjects With Myeloid/Lymphoid Neoplasms With FGFR1 Rearrangement - (FIGHT-203)



Status:Recruiting
Conditions:Lymphoma, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - Any
Updated:10/12/2018
Start Date:December 26, 2016
End Date:December 2019
Contact:Incyte Corporation Call Center
Phone:1.855.463.3463

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A Phase 2, Open-Label, Monotherapy, Multicenter 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.


Inclusion Criteria:

- 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.

- Subjects must be relapsed/refractory. Prior stem cell transplantation is allowed.

- Life expectancy ≥ 12 weeks.

- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.

Exclusion Criteria:

- 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.
We found this trial at
10
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New York, New York 10021
Principal Investigator: Ellen Ritchie
Phone: 212-746-1534
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1365 Clifton Rd NE
Atlanta, Georgia 30322
(404) 778-1900
Principal Investigator: Elliott Winton
Phone: 404-778-4334
Winship Cancer Institute at Emory University Winship Cancer Institute of Emory University is Georgia
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Duarte, California 91010
Principal Investigator: Haris Ali
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1515 Holcombe Boulevard
Houston, Texas 77030
Principal Investigator: Srdan Verstovsek
Phone: 713-563-2622
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Indianapolis, Indiana 46237
Principal Investigator: Luke Akard
Phone: 317-528-7298
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Indianapolis, IN
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4 Seilerstätte
Linz, 4020
Principal Investigator: Andreas Petzer
Phone: +43 732 7677 4319
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Palo Alto, California 94304
Principal Investigator: Jason Gotlib
Phone: 650-723-1367
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5777 East Mayo Boulevard
Phoenix, Arizona 85054
(480) 515-6296
Principal Investigator: Jeanne Palmer
Phone: 480-342-6034
Mayo Clinic Mayo Clinic's campus in Arizona provides medical care for thousands of people from...
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660 South Euclid Avenue
Saint Louis, Missouri 63110
Principal Investigator: Stephen Oh
Phone: 314-362-0156
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Saint Louis, MO
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Salt Lake City, Utah 84112
Principal Investigator: Michael Deininger
Phone: 801-587-9178
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