Efficacy and Safety of Pemigatinib in Previously Treated Locally Advanced/Metastatic or Surgically Unresectable Solid Tumor Malignancies Harboring Activating FGFR Mutations or Translocations (FIGHT-207)
NCT ID: NCT03822117
Last Updated: 2025-11-04
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
111 participants
INTERVENTIONAL
2019-10-17
2022-03-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Pemigatinib
Cohort A (Solid tumor malignancies with FGFR1-3 in frame fusions; any FGFR2 rearrangement; FGFR1/3 rearrangement with known partner\*). Cohort B (Solid tumor malignancies with known or likely activating mutations (excluding kinase domain) in FGFR1-3) Cohort C (Solid tumor malignancies with FGFR1-3 known activating mutations in kinase domain; FGFR1-3 putatively activating mutations; other FGFR1/3 rearrangements\* (not eligible for Cohort A)).
\*Only FGFR fusions or rearrangements with an intact kinase domain are eligible
Pemigatinib
Pemigatinib administered orally once daily (QD).
Interventions
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Pemigatinib
Pemigatinib administered orally once daily (QD).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Radiographically measurable disease (per RECIST v1.1 or RANO for primary brain tumors). Tumor lesions located in a previously irradiated area or in an area subjected to other loco-regional therapy are considered measureable if progression has been clearly demonstrated in the lesion.
* Documentation of an FGFR1-3 gene mutation or translocation.
* Objective progression after at least 1 prior therapy and no therapy available that is likely to provide clinical benefit. Participants who are intolerant to or decline the approved therapy are eligible only if they have no therapy available that is likely to provide clinical benefit.
* Eastern Cooperative Oncology Group performance status 0 to 2.
* Baseline archival tumor specimen (if less than 24 months from date of screening) or willingness to undergo a pretreatment tumor biopsy to obtain the specimen. Must be a tumor block or approximately 15 unstained slides from biopsy or resection of primary tumor or metastasis.
* Willingness to avoid pregnancy or fathering children.
Exclusion Criteria
* Receipt of anticancer medications or investigational drugs for any indication or reason within 28 days before first dose of pemigatinib.
* Cannot be a candidate for potentially curative surgery.
* Current evidence of clinically significant corneal or retinal disorder as confirmed by ophthalmologic examination.
* Radiation therapy administered within 2 weeks of enrollment/first dose of study treatment.
* Untreated brain or central nervous system (CNS) metastases or brain or CNS metastases that have progressed (eg, evidence of new or enlarging brain metastasis or new neurological symptoms attributable to brain or CNS metastases).
* Known additional malignancy that is progressing or requires active treatment.
* History of calcium and phosphate hemostasis disorder or systemic mineral imbalance with ectopic calcification of soft tissues.
* Clinically significant or uncontrolled cardiac disease.
* Active chronic or current infectious disease requiring systemic antibiotic, antifungal, or antiviral treatment within 2 weeks before enrollment (participants with asymptomatic chronic infections on prophylactic treatment are allowed).
* Evidence of active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection (defined as elevated transaminases or cirrhosis; chronic HBV/HCV infection with no cirrhosis and no elevated transaminases is allowed).
* Known HIV infection.
* Use of any potent CYP3A4 inhibitors or inducers or moderate CYP3A4 inducers within 14 days or five half-lives (whichever is longer) before the first dose of study drug/treatment.
* Women who are pregnant or breastfeeding.
18 Years
ALL
No
Sponsors
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Incyte Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Peter Langmuir, MD
Role: STUDY_DIRECTOR
Incyte Corporation
Locations
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Samsung Medical Center
Seoul, , South Korea
Cancer Treatment Centers of America
Goodyear, Arizona, United States
Mayo Clinic Hospital
Phoenix, Arizona, United States
The University of Arizona Cancer Center
Tucson, Arizona, United States
Chao Family Comprehensive Cancer Center University of California, Irvine
Orange, California, United States
Stanford Cancer Center
Palo Alto, California, United States
John Wayne Cancer Institute
Santa Monica, California, United States
St. Joseph Heritage Healthcare
Santa Rosa, California, United States
Florida Cancer Specialists & Research Institute
Fort Myers, Florida, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, United States
Florida Cancer Specialists
St. Petersburg, Florida, United States
Florida Cancer Specialists
Tallahassee, Florida, United States
Florida Cancer Specialists
West Palm Beach, Florida, United States
Illinois Cancer Specialists
Arlington Heights, Illinois, United States
Edward H Kaplan & Associates
Skokie, Illinois, United States
Carle Cancer Center
Urbana, Illinois, United States
Cancer Treatment Centers of America
Zion, Illinois, United States
Indiana University Health - Arnett Cancer Care
Lafayette, Indiana, United States
University of Iowa
Iowa City, Iowa, United States
University of Kansas Cancer Center
Westwood, Kansas, United States
Ochsner Clinic
New Orleans, Louisiana, United States
Central Maine Medical Center
Lewiston, Maine, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Umass Memorial Medical Center, Inc.
Worcester, Massachusetts, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
Summit Medical Group
Florham Park, New Jersey, United States
Winthrop University Hospital
Mineola, New York, United States
Oncology Specialists of Charlotte
Charlotte, North Carolina, United States
Duke Cancer Center
Durham, North Carolina, United States
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States
Stephenson Cancer Center
Oklahoma City, Oklahoma, United States
Southwestern Regional Medical Center
Tulsa, Oklahoma, United States
Cancer Institute of Greenville Health System
Greenville, South Carolina, United States
The West Clinic Pc
Germantown, Tennessee, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Houston Methodist Hospital
Houston, Texas, United States
Joe Arrington Cancer Center
Lubbock, Texas, United States
Virginia Cancer Specialists, Pc
Fairfax, Virginia, United States
Virginia Oncology Associates-Lake Wright
Norfolk, Virginia, United States
Seattle Cancer Care Alliance
Seattle, Washington, United States
Multicare Institute For Research & Innovation
Tacoma, Washington, United States
West Virginia University Hospitals Inc
Morgantown, West Virginia, United States
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, United States
The Finsen Centre National Hospital
Copenhagen, , Denmark
Institut Bergonie
Bordeaux, , France
CENTRE GEORGES FRAN�OIS LECLERC
Dijon, , France
Centre Antoine Lacassagne
Nice, , France
Hospital Saint Louis
Paris, , France
A.P.H. Paris Hopital Cochin
Paris, , France
Institut Universitaire Du Cancer de Toulouse Oncopole
Toulouse, , France
Universitatsklinikum Koln
Cologne, , Germany
University Medical Center Freiburg
Freiburg im Breisgau, , Germany
University Medical Centre Hamburg-Eppendorf, Centre of Oncology
Hamburg, , Germany
University Hospital Grosshadern Munich
Munich, , Germany
Universitaetsklinikum in Tubingen
Tübingen, , Germany
Ha Emek Medical Center
Afula, , Israel
Rambam Health Care Campus
Haifa, , Israel
Hadassah Hebrew University Medical Center Ein Karem Hadassah
Jerusalem, , Israel
Rabin Medical Center - Beilinson Hospital
Petah Tikva, , Israel
Assaf Harofeh Medical Center
Ẕerifin, , Israel
L AZIENDA OSPEDALIERO-UNIVERSITARIA DI BOLOGNA POLICLINICO S. ORSOLA � MALPIGHI
Bologna, , Italy
Fondazione Del Piemonte Per L Oncologia Ircc Candiolo
Candiolo, , Italy
Fondazione Irccs Istituto Nazionale Dei Tumori
Milan, , Italy
Istituto Nazionale Tumori Irccs Fondazione Pascale
Napoli, , Italy
Istituto Nazionale Tumori Regina Elena Irccs
Roma, , Italy
Centro Ricerche Cliniche Di Verona (Crc)
Verona, , Italy
National Hospital Organization Kyushu Cancer Center
Fukuoka, , Japan
Kanazawa University Hospital
Ishikawa, , Japan
Kobe University Hospital
Kobe, , Japan
Tohoku University Hospital
Sendai, , Japan
Keio University Hospital
Shinjuku-ku, , Japan
Shizuoka Cancer Center
Shizuoka, , Japan
Kanagawa Cancer Center
Yokohama, , Japan
National Cancer Center
Goyang-si, , South Korea
Seoul National University Bundang Hospital
Seongnam-si, , South Korea
Severance Hospital Yonsei University Health System
Seoul, , South Korea
Hospital General Universitario Vall D Hebron
Barcelona, , Spain
Hospital Clinic I Provincial
Barcelona, , Spain
Centro Integral Oncologico Clara Campal (Ciocc)
Madrid, , Spain
Hospital Regional Universitario de Malaga
Málaga, , Spain
Clinica Universidad de Navarra (Cun)
Pamplona, , Spain
Hospital Universitario Marques de Valdecilla
Santander, , Spain
Hospital Universitario Y Politcnico de La Fe
Valencia, , Spain
Inselspital - Universitaetsspital Bern
Bern, , Switzerland
Universitatsspital Zurich
Zurich, , Switzerland
University College London Hospitals (Uclh)
London, , United Kingdom
Imperial College Healthcare Nhs Trust - Hammersmith Hospital
London, , United Kingdom
Sarah Cannon Research Institute
London, , United Kingdom
Countries
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References
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Rodon J, Damian S, Furqan M, Garcia-Donas J, Imai H, Italiano A, Spanggaard I, Ueno M, Yokota T, Veronese ML, Oliveira N, Li X, Gilmartin A, Schaffer M, Goyal L. Pemigatinib in previously treated solid tumors with activating FGFR1-FGFR3 alterations: phase 2 FIGHT-207 basket trial. Nat Med. 2024 Jun;30(6):1645-1654. doi: 10.1038/s41591-024-02934-7. Epub 2024 May 6.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2018-004768-69
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
INCB 54828-207
Identifier Type: -
Identifier Source: org_study_id
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