Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Previously Treated Glioblastoma or Other Primary Central Nervous System Tumors Harboring Activating FGFR1-3 Alterations

Last updated: December 19, 2024
Sponsor: Incyte Corporation
Overall Status: Completed

Phase

2

Condition

Neurofibromatosis

Brain Tumor

Brain Cancer

Treatment

Pemigatinib

Clinical Study ID

NCT05267106
INCB 54828-209
  • Ages 18-99
  • All Genders

Study Summary

This is an open-label, monotherapy study of pemigatinib in participants with recurrent glioblastoma (GBM) or other recurrent gliomas, circumscribed astrocytic gliomas, and glioneuronal and neuronal tumors with an activating FGFR1-3 mutation or fusion/rearrangement. This study consists of 2 cohorts, Cohorts A, and B, and will enroll approximately 82 participants into each cohort. Participants will receive pemigatinib 13.5 mg QD on a 2-week on-therapy and 1-week off-therapy schedule as long as they are receiving benefit and have not met any criteria for study withdrawal.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Histological, cytological, or molecular confirmation of recurrent GBM or otherglioma, circumscribed astrocytic glioma, or glioneuronalor neuronal tumors that hasrecurred.

  • Radiographically measurable disease.

. -Karnofsky performance status ≥ 60.

  • Life expectancy ≥ 12 weeks.

  • Documentation of an actionable FGFR1-3 gene mutation or fusion/rearrangement fromtissue : FGFR1-3 fusions or other rearrangements (FGFR1-3 in-frame fusions, anyFGFR2 rearrangement, or FGFR1/3 rearrangement with known partner) or a definedFGFR1-3 activating mutation or in-frame deletion. Only participants with FGFRfusions or rearrangements with an intact kinase domain are eligible.

  • MRI-documented objective progression after prior therapy and must have no therapyavailable that is likely to provide clinical benefit.

  • Most recent archival tumor specimen must be a tumor block or a minimum of 15unstained slides from biopsy or resection of primary tumor or metastasis.

  • Willingness to avoid pregnancy or fathering children.

Exclusion

Exclusion Criteria:

  • Prior receipt of an FGFR inhibitor.

  • Receipt of anticancer medications or investigational drugs for any indication orreason within 28 days before first dose of study drug.

  • Participants may have had treatment for an unlimited number of prior relapses butmust not have had prior bevacizumab or other VEGF/VEGFR inhibitors (exception: priorbevacizumab is allowed if it was administered for the treatment of radiationnecrosis rather than progressive tumor and was stopped at least 12 weeks prior toMRI showing tumor progression).

  • Concurrent anticancer therapy

  • Candidate for potentially curative surgery.

  • Dexamethasone (or equivalent) > 4 mg daily at the time of study registration

  • Current evidence of clinically significant corneal or retinal disorder as confirmedby ophthalmologic examination.

  • Diffuse leptomeningeal disease.

  • Radiation therapy administered within 12 weeks before enrollment/first dose of studydrug.

  • Known additional malignancy that is progressing or requires active systemictreatment.

Study Design

Total Participants: 83
Treatment Group(s): 1
Primary Treatment: Pemigatinib
Phase: 2
Study Start date:
May 20, 2022
Estimated Completion Date:
December 17, 2024

Connect with a study center

  • Aalborg Universitets Hospital

    Aalborg, 09000
    Denmark

    Site Not Available

  • Aarhus University Hospital

    Aarhus, 08200
    Denmark

    Site Not Available

  • Rigshospitalet Uni of Hospital of Copenhagen

    Copenhagen, 02100
    Denmark

    Site Not Available

  • Odense University Hospital

    Odense C, 05000
    Denmark

    Site Not Available

  • Chru de Lille Hopital Claude Huriez

    Lille, 59037
    France

    Site Not Available

  • Chru de Lille Hopital Claude Huriez

    Lille Cedex, 59037
    France

    Site Not Available

  • Chu Hopital de La Timone

    Marseille, 13005
    France

    Site Not Available

  • Chu Hopital de La Timone

    Marseille Cedex 05, 13385
    France

    Site Not Available

  • Hospital Universitaire Pitie-Salpetriere

    Paris, 75013
    France

    Site Not Available

  • Universitaire Du Cancer de Toulouse Institut Claudius Regaud Iuct-Oncopole

    Toulouse, 31059
    France

    Site Not Available

  • Universitatsklinikum Bonn Aoer

    Bonn, 53127
    Germany

    Site Not Available

  • Klinikum Der Johann Wolfgang Goethe University

    Frankfurt, 60528
    Germany

    Site Not Available

  • Universitaetsklinikum Heidelberg

    Heidelberg, 69120
    Germany

    Site Not Available

  • University Hospital Grosshadern Munich

    Muenchen, 81377
    Germany

    Site Not Available

  • University Hospital Tuebingen

    Tuebingen, 72076
    Germany

    Site Not Available

  • Ospedale Bellaria

    Bologna, 40139
    Italy

    Site Not Available

  • Istituto Di Ricovero E Cura A Carattere Scientifico (Irccs) Ospedale San Raffaele

    Milano, 20132
    Italy

    Site Not Available

  • Iov - Istituto Oncologico Veneto Irccs

    Padova, 35128
    Italy

    Site Not Available

  • A.S.L. Napoli 1 Centro Ospedale Del Mare

    Ponticelli, 80147
    Italy

    Site Not Available

  • Irccs Istituto Clinico Humanitas

    Rozzano, 20089
    Italy

    Site Not Available

  • Azienda Ospedaliero Universitaria Citta Della Salute E Della Scienza

    Torino, 10124
    Italy

    Site Not Available

  • University of Tokyo Hospital

    Bunkyo-ku, 113-8655
    Japan

    Site Not Available

  • National Cancer Center Hospital

    Chuo-ku, 104-0045
    Japan

    Site Not Available

  • Kyushu University Hospital

    Fukuoka-shi, 812-8582
    Japan

    Site Not Available

  • Kyoto University Hospital

    Kyoto-shi, 606-8507
    Japan

    Site Not Available

  • Nagoya University Hospital

    Nagoya-shi, 466-8560
    Japan

    Site Not Available

  • Tohoku University Hospital

    Sendai-shi, 980-8574
    Japan

    Site Not Available

  • Netherlands Cancer Institute Antoni Van Leeuwenhoek Ziekenhuis

    Amsterdam, 1066 CX
    Netherlands

    Site Not Available

  • Erasmus Mc Cancer Institute

    Rotterdam, 3015 GD
    Netherlands

    Site Not Available

  • University Medical Center Utrecht

    Utrecht, 3584 CX
    Netherlands

    Site Not Available

  • Hospital Clinic Barcelona Main

    Barcelona, 08036
    Spain

    Site Not Available

  • Hospital Clinic de Barcelona

    Barcelona, 08036
    Spain

    Active - Recruiting

  • Hospital Del Mar

    Barcelona, 08003
    Spain

    Site Not Available

  • Hospital General Universitario Vall D Hebron

    Barcelona, 08035
    Spain

    Site Not Available

  • Hospital de La Santa Creu I Sant Pau

    Barcelona, 08041
    Spain

    Site Not Available

  • Ico Institut Catala D Oncologia

    Barcelona, 08908
    Spain

    Active - Recruiting

  • Ico Girona Hospital Universitari de Girona Dr Josep Trueta

    Girona, 17007
    Spain

    Site Not Available

  • Ico Institut Catala D Oncologia

    L'hospitalet de Llobregat, 08908
    Spain

    Site Not Available

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28007
    Spain

    Site Not Available

  • Hospital Universitario 12 de Octubre

    Madrid, 28041
    Spain

    Site Not Available

  • Hospital Universitario Hm Sanchinarro

    Madrid, 28050
    Spain

    Site Not Available

  • Hospital Universitario Ramon Y Cajal

    Madrid, 28034
    Spain

    Site Not Available

  • Clinica Universidad de Navarra (Cun)

    Pamplona, 31008
    Spain

    Site Not Available

  • Hospital General de Catalunya

    Sant Cugat Del Valles, 08190
    Spain

    Site Not Available

  • Hospital Universitario Virgen Del Rocio

    Sevilla, 41013
    Spain

    Site Not Available

  • Hospital General Universitario de Valencia

    Valencia, 46014
    Spain

    Site Not Available

  • Addenbrooke'S Hospital

    Cambridge, CB2 0QQ
    United Kingdom

    Site Not Available

  • Velindre Cancer Centre

    Cardiff, CF14 2TL
    United Kingdom

    Site Not Available

  • St James'S University Hospital

    Leeds, LS9 7TF
    United Kingdom

    Site Not Available

  • Guys Hospital

    London, SE1 9RT
    United Kingdom

    Site Not Available

  • The Royal Marsden Nhs Foundation Trust - Chelsea

    London, SW36JJ
    United Kingdom

    Site Not Available

  • The Royal Marsden Nhs Foundation Trust - Sutton

    London, SW3 6JJ
    United Kingdom

    Site Not Available

  • The Christie Nhs Foundation Trust Uk

    Manchester, M20 4BX
    United Kingdom

    Site Not Available

  • The Clatterbridge Cancer Centre

    Wirral, CH63 4JY
    United Kingdom

    Site Not Available

  • Valkyrie Clinical Trials

    Beverly Hills, California 90211
    United States

    Site Not Available

  • City of Hope National Medical Center

    Duarte, California 91010
    United States

    Site Not Available

  • Providence Medical Foundation

    Fullerton, California 92835
    United States

    Site Not Available

  • Usc Norris Comprehensive Cancer Center

    Los Angeles, California 90033
    United States

    Site Not Available

  • Stanford Neuroscience Health Center

    Sacramento, California 94304
    United States

    Site Not Available

  • Sharp Memorial Hospital

    San Diego, California 92123
    United States

    Site Not Available

  • University of California San Francisco

    San Francisco, California 94143
    United States

    Site Not Available

  • Providence St Joseph Hospital Orange Center For Cancer Prevention and Treatment

    Santa Monica, California 90404
    United States

    Site Not Available

  • Yale Cancer Center

    New Haven, Connecticut 06510-3220
    United States

    Site Not Available

  • Lynn Cancer Institute Marcus Neuroscience Institute

    Boca Raton, Florida 33486-2304
    United States

    Site Not Available

  • Baptist Md Anderson Cancer Center

    Jacksonville, Florida 32207
    United States

    Site Not Available

  • Miami Cancer Institute

    Miami, Florida 33176
    United States

    Site Not Available

  • Orlando Health Cancer Institute Downtown Orlando

    Orlando, Florida 32806
    United States

    Site Not Available

  • H. Lee Moffitt Cancer Center and Research Institute Hospital

    Tampa, Florida 33612
    United States

    Site Not Available

  • Tampa General Hospital/University of South Florida

    Tampa, Florida 33606
    United States

    Site Not Available

  • Rush University Medical Center-Consultants in Hematology

    Chicago, Illinois 60612
    United States

    Site Not Available

  • University of Chicago

    Chicago, Illinois 60612
    United States

    Site Not Available

  • University of Illinois Hospital & Health Sciences System

    Chicago, Illinois 60612
    United States

    Site Not Available

  • University of Iowa Hospital and Clinics

    Iowa City, Iowa 52242
    United States

    Site Not Available

  • University Medical Center New Orleans

    New Orleans, Louisiana 70112
    United States

    Site Not Available

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • University of Minnesota Health Clinics and Surgery Center

    Minneapolis, Minnesota 55455
    United States

    Site Not Available

  • Washington University

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Northwell Health

    Lake Success, New York 11042
    United States

    Site Not Available

  • Columbia University Irving Medical Center

    New York, New York 10032
    United States

    Site Not Available

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10065
    United States

    Site Not Available

  • East Carolina University

    Greenville, North Carolina 27834
    United States

    Site Not Available

  • Vidant Medical Center

    Greenville, North Carolina 27834
    United States

    Site Not Available

  • Comprehensive Cancer Center of Wake Forest University

    Winston-Salem, North Carolina 27157
    United States

    Active - Recruiting

  • Wake Forest Baptist Health

    Winston-Salem, North Carolina 27157
    United States

    Site Not Available

  • UC Health At Cincinnati Va Medical Center

    Cincinnati, Ohio 45229
    United States

    Site Not Available

  • Cleveland Clinic Foundation

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • The Ohio State University

    Columbus, Ohio 43210
    United States

    Site Not Available

  • Spoknwrd Clinical Trials Inc.

    Easton, Pennsylvania 18045
    United States

    Site Not Available

  • University of Pennsylvania Hospital

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • University of Pittsburgh Medical Center Health System

    Pittsburgh, Pennsylvania 15232
    United States

    Site Not Available

  • Rhode Island Hospital

    Providence, Rhode Island 02903
    United States

    Site Not Available

  • Tennessee Oncology

    Chattanooga, Tennessee 37403
    United States

    Site Not Available

  • Tennessee Oncology

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Baylor University Medical Center

    Dallas, Texas 75246
    United States

    Site Not Available

  • Jps Health Network

    Fort Worth, Texas 76104
    United States

    Site Not Available

  • Houston Methodist Hospital

    Houston, Texas 77030
    United States

    Site Not Available

  • Huntsman Cancer Institute

    Salt Lake City, Utah 84112
    United States

    Site Not Available

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington 98109
    United States

    Site Not Available

  • West Virginia University Cancer Institute

    Morgantown, West Virginia 26506
    United States

    Site Not Available

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