A Study to Evaluate the Efficacy and Safety of Pemigatinib (INCB054828) in Subjects With Urothelial Carcinoma - (FIGHT-201)



Status:Recruiting
Conditions:Prostate Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:10/12/2018
Start Date:August 2016
End Date:January 2020
Contact:Incyte Corporation Call Center
Phone:1.855.463.3463

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A Phase 2, Open-Label, Single-Agent, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib (INCB054828) in Subjects With Metastatic or Surgically Unresectable Urothelial Carcinoma Harboring FGF/FGFR Alterations - (FIGHT-201)

The purpose of this study is to evaluate the overall response rate (ORR) of pemigatinib as a
monotherapy in the treatment of metastatic or surgically unresectable urothelial carcinoma
harboring FGF/FGFR alterations.


Inclusion Criteria:

- 20 years and older in Japan

- Histologically documented metastatic or surgically unresectable urothelial carcinoma;
may include primary site from urethra, ureters, upper tract, renal pelvis, and
bladder.

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

- Life expectancy ≥ 12 weeks.

- Radiographically measurable per RECIST v1.1.

- Documented FGF/FGFR alteration and have either 1a) failed at least 1 previous
treatment for their metastatic or surgically unresectable urothelial carcinoma (ie,
chemotherapy, immunotherapy) or 1b) have not received chemotherapy due to poor ECOG
status or 2) have insufficient renal function.

Exclusion Criteria:

- Prior receipt of a selective FGFR inhibitor.

- Use of any potent CYP3A4 inhibitors or inducers within 14 days or 5 half-lives
(whichever is shorter) before the first dose of study drug.

- Inability or unwillingness to swallow pemigatinib or significant gastrointestinal
disorder(s) that could interfere with the absorption, metabolism, or excretion of
pemigatinib.
We found this trial at
32
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1648 Pierce Dr NE
Atlanta, Georgia 30322
(404) 727-5640
Phone: 404-778-3448
Emory University School of Medicine Emory University School of Medicine has 2,359 full- and part-time...
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Chapel Hill, North Carolina 27599
(919) 962-2211
Phone: 919-966-4432
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Phone: 615-875-8605
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Phone: 503-494-3618
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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Portland, OR
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60 Crittenden Blvd # 70
Rochester, New York 14642
(585) 275-2121
Phone: 585-275-3351
University of Rochester The University of Rochester is one of the country's top-tier research universities....
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Albany, New York 12206
Phone: 518-262-2768
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Austin, Texas 78705
Phone: 512-421-4100
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22 South Greene Street
Baltimore, Maryland 21201
410-328-7904
Phone: 410-328-8610
University of Maryland Greenebaum Cancer Center The University of Maryland Marlene and Stewart Greenebaum Cancer...
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Baltimore, MD
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Bethlehem, Pennsylvania 18015
Phone: 484-503-4150
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Burlington, Massachusetts 01805
Phone: 781-744-2734
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5053 Wooster Rd
Cincinnati, Ohio 45226
(513) 751-2273
Phone: 513-751-2273
Oncology Hematology Care Our more than 60 physicians and advanced practice providers throughout neighborhood offices...
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Dallas, Texas 75246
Phone: 214-370-1000
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Edegem, 2650
Phone: 3238215681
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1906 Blake Avenue
Glenwood Springs, Colorado 81601
Phone: 970-384-7574
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Houston, Texas 77024
Phone: 713-467-1722
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3730 South Eastern Avenue
Las Vegas, Nevada 89169
Phone: 702-952-3439
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600 Highland Avenue
Madison, Wisconsin 53792
Phone: 608-263-7107
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Miami Beach, Florida 33140
Phone: 305-674-2625
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8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
Phone: 414-805-8921
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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823 82nd Parkway, Suite B
Myrtle Beach, South Carolina 29572
(843) 449-1010 ext.268
Phone: 843-449-1010
Carolina Urologic Research Center Carolina Urologic Research Center (CURC) has been recognized both nationally and...
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450 Lakeville Road
New Hyde Park, New York 11042
Phone: 516-734-8812
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Norfolk, Virginia 23502
Phone: 757-213-5615
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Omaha, Nebraska 68130
Phone: 402-991-8468
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Orlando, Florida 32804
Phone: 407-303-2093
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Pittsburgh, Pennsylvania 15240
Phone: 412-360-6230
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Salt Lake City, Utah 84112
Phone: 801-587-4765
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7901 Frost Street
San Diego, California 92123
858-939-3400
Phone: 858-939-5062
Sharp Memorial Hospital Sharp Memorial Hospital offers clinical excellence with the latest technology and patient-centered...
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1450 3rd Street
San Francisco, California 94158
Phone: 415-353-4310
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Tacoma, Washington 98405
Phone: 253-306-0532
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Temple, Texas 76508
Phone: 254-724-5939
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19260 Southwest 65th Avenue
Tualatin, Oregon 97062
Phone: 503-291-6233
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Tucson, Arizona 85710
Phone: 520-546-2870
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