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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 (FIGHT-209)

Primary Purpose

Glioblastoma, Adult-type Diffuse Gliomas

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Pemigatinib
Sponsored by
Incyte Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glioblastoma focused on measuring glioblastoma, GBM, adult-type diffuse gliomas, gliomas, oligodendroglioma, FGFR1-3 Alteration, FGFR1-3 fusions, FGFR1-3 rearrangements, Central nervous system tumor, isocitrate dehydrogenase, IDH-mutant astocytoma, IDH-wild-type GBM, glioneuronal, neuronal, circumscribed astrocytic glioma

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Histological, cytological, or molecular confirmation of recurrent GBM or other adult-type, diffuse glioma or circumscribed astrocytic tumors.

    - For Cohorts A and C: Prior histopathologically proven WHO grade 4, IDH-wild-type GBM OR molecular diagnosis of IDH-wild-type, diffuse astrocytic glioma with molecular features of WHO grade 4 GBM (astrocytic glioma requires presence of either amplification of EGFR, whole chromosome 7 gain and whole chromosome 10 loss, or TERT-promoter mutation; Louis et al 2021) that has recurred or progressed on or after treatment with at least 1 line of standard of care therapy (eg, temozolomide and radiotherapy or radiotherapy).

    • For Cohorts B and C: Prior histopathologically proven, per WHO criteria, adult-type diffuse gliomas other than GBM, including IDH-mutant astrocytoma and IDH-mutant and 1p/19q codeleted oligodendroglioma, and circumscribed astrocytic tumors, including pilocytic astrocytomas, that are recurrent or progressed on or after at least 1 line of standard of care therapy (eg, radiotherapy and/or treatment with an alkylating chemotherapy such as TMZ, CCNU, or BCNU-containing chemotherapy). For Cohort C, all gliomas and glioneuronal and neuronal tumors with a known or likely FGFR 1-3 activating mutation are also eligible.
  • Radiographically measurable disease. Tumor lesions located in a previously irradiated area, or in an area subjected to other loco-regional therapy, are considered measurable if progression has been clearly demonstrated in the lesion.
  • Karnofsky performance status ≥ 60.
  • Life expectancy ≥ 12 weeks.
  • Documentation of an FGFR1-3 gene mutation or fusion/rearrangement from tissue (cfDNA from a qualified laboratory such as FMI or Guardant Health may be acceptable after review by medical monitor).

    • Cohort A: Participants with prior, histopathologically proven, WHO grade 4,IDH-wild-type GBM OR molecular diagnosis of IDH-wild-type, diffuse astrocytic glioma with molecular features of WHO grade 4 GBM (astrocytic glioma requires presence of either amplification of EGFR, whole chromosome 7 gain and whole chromosome 10 loss, or TERT-promoter mutation; Louis et al 2021) that has recurred, harboring FGFR1-3 fusions or rearrangements (FGFR1-3 in-frame fusions, any FGFR2 rearrangement, or FGFR1/3 rearrangement with known partner). Only FGFR fusions or rearrangements with an intact kinase domain are eligible.
    • Cohort B: Participants with other histopathologically proven, per WHO criteria dult-type, diffuse gliomas other than GBM, including IDH-mutant astrocytoma and IDH-mutant and 1p/19q codeleted oligodendroglioma, and circumscribed astrocytic tumors, including pilocytic astrocytomas that are recurrent, harboring FGFR1-3 fusions or rearrangements (FGFR1-3 in-frame fusions, any FGFR2 rearrangement, or FGFR1/3 rearrangement with known partner). Only FGFR fusions or rearrangements with an intact kinase domain are eligible.
    • Cohort C: Participants with prior, histopathologically proven, WHO grade 4, IDH-wild-type GBM or molecular diagnosis of IDH-wild-type, diffuse astrocytic glioma with molecular features of WHO grade 4 GBM that has recurred or histopathologically proven, per WHO criteria, adult-type, diffuse gliomas other than GBM, including IDH-mutant astrocytoma and IDH-mutant and 1p/19q codeleted oligodendroglioma, and circumscribed astrocytic tumors, including pilocytic astrocytomas, that are recurrent with a known or likely activating mutation or FGFR1-3 mutation. All gliomas and glioneuronal and neuronal tumors with a known or likely FGFR 1-3 activating mutation are also eligible.
  • MRI-documented objective progression after prior therapy and must have no therapy available that is likely to provide clinical benefit. An interval of at least 12 weeks after prior radiotherapy is required unless there is either histopathological confirmation of recurrent tumor or new enhancement on MRI outside the radiotherapy field. Participants who are intolerant of or decline the approved therapy are eligible only if they have no therapy available that is likely to provide clinical benefit.
  • Baseline archival tumor specimen less than 24 months from date of screening. Must be a tumor block or a minimum of 15 unstained slides from biopsy or resection of primary tumor or metastasis.
  • Willingness to avoid pregnancy or fathering children.

Exclusion Criteria:

  • Prior receipt of a selective FGFR inhibitor.
  • Receipt of anticancer medications or investigational drugs for any indication or reason within 28 days before first dose of study drug. Participants must have recovered (≤ Grade 1 as per CTCAE v5.0 or at pretreatment baseline) from AEs from previously administered therapies (excluding alopecia).
  • Participants may have had treatment for an unlimited number of prior relapses but must not have had prior bevacizumab or other VEGF/VEGFR inhibitors (exception: prior bevacizumab is allowed if it was administered for the treatment of radiation necrosis rather than progressive tumor and was stopped at least 12 weeks prior to MRI showing tumor progression).
  • Concurrent anticancer therapy (eg, chemotherapy, immunotherapy, biologic therapy, hormonal therapy, investigational therapy, or tumor embolization).
  • Candidate for potentially curative surgery.
  • Dexamethasone (or equivalent) > 4 mg daily at the time of study registration (higher doseof steroid for symptom control is allowed during the study).
  • Current evidence of clinically significant corneal (including but not limited to bullous/band keratopathy, corneal abrasion, inflammation/ulceration, and keratoconjunctivitis) or retinal disorder (including but not limited to macular/retinal degeneration, diabetic retinopathy, and retinal detachment) as confirmed by ophthalmologic examination.
  • Diffuse leptomeningeal disease.
  • Radiation therapy administered within 12 weeks before enrollment/first dose of study drug. An interval of at least 12 weeks after prior radiotherapy is required unless there is either histopathological confirmation of recurrent tumor or new enhancement on MRI outside the radiotherapy field.
  • Known additional malignancy that is progressing or requires active systemic treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin,or in situ cervical cancer that has undergone potentially curative therapy.
  • Participants with defined laboratory values at screening.

Sites / Locations

  • Valkyrie Clinical TrialsRecruiting
  • City of Hope National Medical CenterRecruiting
  • Providence Medical FoundationRecruiting
  • Usc Norris Comprehensive Cancer CenterRecruiting
  • Stanford Neuroscience Health CenterRecruiting
  • Sharp Memorial HospitalRecruiting
  • University of California San FranciscoRecruiting
  • Providence St Joseph Hospital Orange Center For Cancer Prevention and TreatmentRecruiting
  • Yale Cancer CenterRecruiting
  • Baptist Md Anderson Cancer CenterRecruiting
  • Miami Cancer InstituteRecruiting
  • Orlando Health Cancer Institute Downtown Orlando
  • Tampa General Hospital/University of South Florida
  • H. Lee Moffitt Cancer Center and Research Institute HospitalRecruiting
  • Rush University Medical Center-Consultants in Hematology
  • University of Illinois Hospital & Health Sciences SystemRecruiting
  • University of Iowa Hospital and ClinicsRecruiting
  • University Medical Center New Orleans
  • University of Minnesota Health Clinics and Surgery Center
  • Washington University
  • Northwell HealthRecruiting
  • Columbia University Irving Medical CenterRecruiting
  • Memorial Sloan Kettering Cancer CenterRecruiting
  • East Carolina UniversityRecruiting
  • Wake Forest Baptist HealthRecruiting
  • UC Health At Cincinnati Va Medical CenterRecruiting
  • Cleveland Clinic FoundationRecruiting
  • The Ohio State University
  • Spoknwrd Clinical Trials Inc.
  • University of Pennsylvania HospitalRecruiting
  • University of Pittsburgh Medical Center Health SystemRecruiting
  • Rhode Island Hospital
  • Tennessee OncologyRecruiting
  • Tennessee OncologyRecruiting
  • Baylor University Medical CenterRecruiting
  • Houston Methodist HospitalRecruiting
  • Huntsman Cancer InstituteRecruiting
  • Fred Hutchinson Cancer Research CenterRecruiting
  • West Virginia University Cancer Institute
  • Aalborg Universitets HospitalRecruiting
  • Rigshospitalet Uni of Hospital of CopenhagenRecruiting
  • Odense University HospitalRecruiting
  • Chru de Lille Hopital Claude HuriezRecruiting
  • Chu Hopital de La TimoneRecruiting
  • Hospital Universitaire Pitie-SalpetriereRecruiting
  • Universitaire Du Cancer de Toulouse Institut Claudius Regaud Iuct-OncopoleRecruiting
  • Universitatsklinikum Bonn AoerRecruiting
  • Klinikum Der Johann Wolfgang Goethe UniversityRecruiting
  • Universitaetsklinikum HeidelbergRecruiting
  • University Hospital Grosshadern Munich
  • University Hospital TuebingenRecruiting
  • Ospedale BellariaRecruiting
  • Istituto Di Ricovero E Cura A Carattere Scientifico (Irccs) Ospedale San RaffaeleRecruiting
  • Iov - Istituto Oncologico Veneto IrccsRecruiting
  • A.S.L. Napoli 1 Centro Ospedale Del MareRecruiting
  • Irccs Istituto Clinico HumanitasRecruiting
  • Azienda Ospedaliero Universitaria Citta Della Salute E Della ScienzaRecruiting
  • University of Tokyo HospitalRecruiting
  • National Cancer Center HospitalRecruiting
  • Kyushu University HospitalRecruiting
  • Kyoto University HospitalRecruiting
  • Nagoya University HospitalRecruiting
  • Tohoku University HospitalRecruiting
  • Netherlands Cancer Institute Antoni Van Leeuwenhoek ZiekenhuisRecruiting
  • Erasmus Mc Cancer InstituteRecruiting
  • Hospital Del MarRecruiting
  • Hospital General Universitario Vall D HebronRecruiting
  • Hospital Clinic Barcelona MainRecruiting
  • Hospital de La Santa Creu I Sant PauRecruiting
  • Ico Institut Catala D OncologiaRecruiting
  • Ico Girona Hospital Universitari de Girona Dr Josep TruetaRecruiting
  • Hospital General Universitario Gregorio MaranonRecruiting
  • Hospital Universitario Ramon Y CajalRecruiting
  • Hospital Universitario 12 de OctubreRecruiting
  • Hospital Universitario Hm SanchinarroRecruiting
  • Clinica Universidad de Navarra (Cun)Recruiting
  • Hospital General de CatalunyaRecruiting
  • Hospital Universitario Virgen Del RocioRecruiting
  • Hospital General Universitario de ValenciaRecruiting
  • Addenbrooke'S HospitalRecruiting
  • Velindre Cancer CentreRecruiting
  • St James'S University HospitalRecruiting
  • Guys HospitalRecruiting
  • The Royal Marsden Nhs Foundation Trust - SuttonRecruiting
  • The Royal Marsden Nhs Foundation Trust - ChelseaRecruiting
  • The Christie Nhs Foundation Trust UkRecruiting
  • The Clatterbridge Cancer Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Cohort A: IDH-wild-type GBM

Cohort B: Other gliomas other than GBM

Arm Description

Participants with histopathologically proven, WHO Grade 4, IDH-wild-type GBM OR molecular diagnosis of IDH-wild-type, diffuse astrocytic glioma with molecular features of Grade 4 GBM that are recurrent, harboring FGFR1-3 fusions/or other rearrangements, or with a defined FGFR1-3 mutation or in-frame deletion.

Participants with other histopathologically proven gliomas other than GBM, circumscribed astrocytic gliomas, and glioneuronal and neuronal tumors that are recurrent, harboring FGFR1-3 fusions/or other rearrangements or with a defined FGFR1-3 activating mutation or in-frame deletion

Outcomes

Primary Outcome Measures

Cohort A: Overall Response Rate (ORR)
Defined as the proportion of participants in Cohort A who achieve a best overall response (BOR) of complete response (CR) or partial response (PR) based on Response Assessment in Neuro-Oncology (RANO) as determined by an Independent Central Radiology (ICR).

Secondary Outcome Measures

Cohort B : ORR
Defined as the proportion of participants who achieve a CR or PR based on RANO. Response will be determined by an ICR review.
Cohorts A and B combined: ORR
Defined as the proportion of participants in Cohorts A and B who achieve a BOR of CR or PR based on RANO as determined by an ICR.
Cohorts A and B: Disease Control Rate (DCR)
Defined as the proportion of participants who achieve a CR, PR, or SD as assessed by ICR in cohorts A and B respectively
Cohorts A and B: Progression-Free Survival (PFS)
Defined as the time from first dose until progressive disease (according to RANO and assessed by an ICR) or death (whichever occurs first) in cohorts A and B, respectively
Cohorts A and B: Overall Survival (OS)
Defined as the time from first dose of study drug to death due to any cause in cohorts A and B respectively
Safety and tolerability
Safety and tolerability in each cohort, assessed by monitoring the frequency and severity of AEs according to NCICTCAE v5.0.
Cohorts A and B : Duration Of Response (DOR)
Defined as the time from first assessment of Complete Response (CR) or Partial Response (PR) until progressive disease (according to RANO and assessed by an ICR), or death (whichever occurs first) in cohorts A and B, respectively

Full Information

First Posted
February 15, 2022
Last Updated
October 18, 2023
Sponsor
Incyte Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT05267106
Brief Title
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
Acronym
FIGHT-209
Official Title
A Phase 2, Open-Label, Single-Arm, Multicenter 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 (FIGHT-209)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 20, 2022 (Actual)
Primary Completion Date
January 30, 2026 (Anticipated)
Study Completion Date
January 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Incyte Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioblastoma, Adult-type Diffuse Gliomas
Keywords
glioblastoma, GBM, adult-type diffuse gliomas, gliomas, oligodendroglioma, FGFR1-3 Alteration, FGFR1-3 fusions, FGFR1-3 rearrangements, Central nervous system tumor, isocitrate dehydrogenase, IDH-mutant astocytoma, IDH-wild-type GBM, glioneuronal, neuronal, circumscribed astrocytic glioma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
This study consists of 2 cohorts and participants will receive pemigatinib 13.5 mg QD on a 2-week on-therapy and 1-week off-therapy schedule.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
164 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cohort A: IDH-wild-type GBM
Arm Type
Experimental
Arm Description
Participants with histopathologically proven, WHO Grade 4, IDH-wild-type GBM OR molecular diagnosis of IDH-wild-type, diffuse astrocytic glioma with molecular features of Grade 4 GBM that are recurrent, harboring FGFR1-3 fusions/or other rearrangements, or with a defined FGFR1-3 mutation or in-frame deletion.
Arm Title
Cohort B: Other gliomas other than GBM
Arm Type
Experimental
Arm Description
Participants with other histopathologically proven gliomas other than GBM, circumscribed astrocytic gliomas, and glioneuronal and neuronal tumors that are recurrent, harboring FGFR1-3 fusions/or other rearrangements or with a defined FGFR1-3 activating mutation or in-frame deletion
Intervention Type
Drug
Intervention Name(s)
Pemigatinib
Other Intervention Name(s)
NCB054828
Intervention Description
13.5mg tablet taken every morning (unless otherwise directed) for 2 weeks and then 1 week off.
Primary Outcome Measure Information:
Title
Cohort A: Overall Response Rate (ORR)
Description
Defined as the proportion of participants in Cohort A who achieve a best overall response (BOR) of complete response (CR) or partial response (PR) based on Response Assessment in Neuro-Oncology (RANO) as determined by an Independent Central Radiology (ICR).
Time Frame
Up to 3 months
Secondary Outcome Measure Information:
Title
Cohort B : ORR
Description
Defined as the proportion of participants who achieve a CR or PR based on RANO. Response will be determined by an ICR review.
Time Frame
up to 3 months
Title
Cohorts A and B combined: ORR
Description
Defined as the proportion of participants in Cohorts A and B who achieve a BOR of CR or PR based on RANO as determined by an ICR.
Time Frame
Up to 3 months
Title
Cohorts A and B: Disease Control Rate (DCR)
Description
Defined as the proportion of participants who achieve a CR, PR, or SD as assessed by ICR in cohorts A and B respectively
Time Frame
Up to 3 months
Title
Cohorts A and B: Progression-Free Survival (PFS)
Description
Defined as the time from first dose until progressive disease (according to RANO and assessed by an ICR) or death (whichever occurs first) in cohorts A and B, respectively
Time Frame
Up to 3 months
Title
Cohorts A and B: Overall Survival (OS)
Description
Defined as the time from first dose of study drug to death due to any cause in cohorts A and B respectively
Time Frame
Up to 3 months
Title
Safety and tolerability
Description
Safety and tolerability in each cohort, assessed by monitoring the frequency and severity of AEs according to NCICTCAE v5.0.
Time Frame
Up to 3 months
Title
Cohorts A and B : Duration Of Response (DOR)
Description
Defined as the time from first assessment of Complete Response (CR) or Partial Response (PR) until progressive disease (according to RANO and assessed by an ICR), or death (whichever occurs first) in cohorts A and B, respectively
Time Frame
up to 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histological, cytological, or molecular confirmation of recurrent GBM or other glioma, circumscribed astrocytic glioma, or glioneuronalor neuronal tumors that has recurred. Radiographically measurable disease. . -Karnofsky performance status ≥ 60. Life expectancy ≥ 12 weeks. Documentation of an actionable FGFR1-3 gene mutation or fusion/rearrangement from tissue : FGFR1-3 fusions or other rearrangements (FGFR1-3 in-frame fusions, any FGFR2 rearrangement, or FGFR1/3 rearrangement with known partner) or a defined FGFR1-3 activating mutation or in-frame deletion. Only participants with FGFR fusions or rearrangements with an intact kinase domain are eligible. MRI-documented objective progression after prior therapy and must have no therapy available that is likely to provide clinical benefit. Most recent archival tumor specimen must be a tumor block or a minimum of 15 unstained slides from biopsy or resection of primary tumor or metastasis. Willingness to avoid pregnancy or fathering children. Exclusion Criteria: Prior receipt of an FGFR inhibitor. Receipt of anticancer medications or investigational drugs for any indication or reason within 28 days before first dose of study drug. Participants may have had treatment for an unlimited number of prior relapses but must not have had prior bevacizumab or other VEGF/VEGFR inhibitors (exception: prior bevacizumab is allowed if it was administered for the treatment of radiation necrosis rather than progressive tumor and was stopped at least 12 weeks prior to MRI 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 confirmed by ophthalmologic examination. Diffuse leptomeningeal disease. Radiation therapy administered within 12 weeks before enrollment/first dose of study drug. Known additional malignancy that is progressing or requires active systemic treatment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Incyte Corporation Call Center (US)
Phone
1.855.463.3463
Email
medinfo@incyte.com
First Name & Middle Initial & Last Name or Official Title & Degree
Incyte Corporation Call Center (ex-US)
Phone
+800 00027423
Email
eumedinfo@incyte.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Victoria Ebiana, MD
Organizational Affiliation
Incyte Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Valkyrie Clinical Trials
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Individual Site Status
Recruiting
Facility Name
City of Hope National Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Individual Site Status
Recruiting
Facility Name
Providence Medical Foundation
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Individual Site Status
Recruiting
Facility Name
Usc Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Individual Site Status
Recruiting
Facility Name
Stanford Neuroscience Health Center
City
Sacramento
State/Province
California
ZIP/Postal Code
94304
Country
United States
Individual Site Status
Recruiting
Facility Name
Sharp Memorial Hospital
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Individual Site Status
Recruiting
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Individual Site Status
Recruiting
Facility Name
Providence St Joseph Hospital Orange Center For Cancer Prevention and Treatment
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Individual Site Status
Recruiting
Facility Name
Yale Cancer Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510-3220
Country
United States
Individual Site Status
Recruiting
Facility Name
Baptist Md Anderson Cancer Center
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Individual Site Status
Recruiting
Facility Name
Miami Cancer Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Individual Site Status
Recruiting
Facility Name
Orlando Health Cancer Institute Downtown Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Individual Site Status
Completed
Facility Name
Tampa General Hospital/University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
H. Lee Moffitt Cancer Center and Research Institute Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Individual Site Status
Recruiting
Facility Name
Rush University Medical Center-Consultants in Hematology
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
University of Illinois Hospital & Health Sciences System
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Iowa Hospital and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Recruiting
Facility Name
University Medical Center New Orleans
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Individual Site Status
Completed
Facility Name
University of Minnesota Health Clinics and Surgery Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Northwell Health
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Individual Site Status
Recruiting
Facility Name
Columbia University Irving Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Name
East Carolina University
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Individual Site Status
Recruiting
Facility Name
Wake Forest Baptist Health
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Individual Site Status
Recruiting
Facility Name
UC Health At Cincinnati Va Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Individual Site Status
Recruiting
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Spoknwrd Clinical Trials Inc.
City
Easton
State/Province
Pennsylvania
ZIP/Postal Code
18045
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
University of Pennsylvania Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Pittsburgh Medical Center Health System
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Individual Site Status
Recruiting
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Tennessee Oncology
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37403
Country
United States
Individual Site Status
Recruiting
Facility Name
Tennessee Oncology
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Recruiting
Facility Name
Baylor University Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Individual Site Status
Recruiting
Facility Name
Houston Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Name
Huntsman Cancer Institute
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Individual Site Status
Recruiting
Facility Name
Fred Hutchinson Cancer Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Individual Site Status
Recruiting
Facility Name
West Virginia University Cancer Institute
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Aalborg Universitets Hospital
City
Aalborg
ZIP/Postal Code
09000
Country
Denmark
Individual Site Status
Recruiting
Facility Name
Rigshospitalet Uni of Hospital of Copenhagen
City
Copenhagen
ZIP/Postal Code
02100
Country
Denmark
Individual Site Status
Recruiting
Facility Name
Odense University Hospital
City
Odense C
ZIP/Postal Code
05000
Country
Denmark
Individual Site Status
Recruiting
Facility Name
Chru de Lille Hopital Claude Huriez
City
Lille Cedex
ZIP/Postal Code
59037
Country
France
Individual Site Status
Recruiting
Facility Name
Chu Hopital de La Timone
City
Marseille
ZIP/Postal Code
13005
Country
France
Individual Site Status
Recruiting
Facility Name
Hospital Universitaire Pitie-Salpetriere
City
Paris
ZIP/Postal Code
75013
Country
France
Individual Site Status
Recruiting
Facility Name
Universitaire Du Cancer de Toulouse Institut Claudius Regaud Iuct-Oncopole
City
Toulouse
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Name
Universitatsklinikum Bonn Aoer
City
Bonn
ZIP/Postal Code
53127
Country
Germany
Individual Site Status
Recruiting
Facility Name
Klinikum Der Johann Wolfgang Goethe University
City
Frankfurt
ZIP/Postal Code
60528
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Individual Site Status
Recruiting
Facility Name
University Hospital Grosshadern Munich
City
Muenchen
ZIP/Postal Code
81377
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
University Hospital Tuebingen
City
Tuebingen
ZIP/Postal Code
72076
Country
Germany
Individual Site Status
Recruiting
Facility Name
Ospedale Bellaria
City
Bologna
ZIP/Postal Code
40139
Country
Italy
Individual Site Status
Recruiting
Facility Name
Istituto Di Ricovero E Cura A Carattere Scientifico (Irccs) Ospedale San Raffaele
City
Milano
ZIP/Postal Code
20132
Country
Italy
Individual Site Status
Recruiting
Facility Name
Iov - Istituto Oncologico Veneto Irccs
City
Padova
ZIP/Postal Code
35128
Country
Italy
Individual Site Status
Recruiting
Facility Name
A.S.L. Napoli 1 Centro Ospedale Del Mare
City
Ponticelli
ZIP/Postal Code
80147
Country
Italy
Individual Site Status
Recruiting
Facility Name
Irccs Istituto Clinico Humanitas
City
Rozzano
ZIP/Postal Code
20089
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliero Universitaria Citta Della Salute E Della Scienza
City
Torino
ZIP/Postal Code
10124
Country
Italy
Individual Site Status
Recruiting
Facility Name
University of Tokyo Hospital
City
Bunkyo-ku
ZIP/Postal Code
113-8655
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Cancer Center Hospital
City
Chuo-ku
ZIP/Postal Code
104-0045
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kyushu University Hospital
City
Fukuoka-shi
ZIP/Postal Code
812-8582
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kyoto University Hospital
City
Kyoto-shi
ZIP/Postal Code
606-8507
Country
Japan
Individual Site Status
Recruiting
Facility Name
Nagoya University Hospital
City
Nagoya-shi
ZIP/Postal Code
466-8560
Country
Japan
Individual Site Status
Recruiting
Facility Name
Tohoku University Hospital
City
Sendai-shi
ZIP/Postal Code
980-8574
Country
Japan
Individual Site Status
Recruiting
Facility Name
Netherlands Cancer Institute Antoni Van Leeuwenhoek Ziekenhuis
City
Amsterdam
ZIP/Postal Code
1066 CX
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Erasmus Mc Cancer Institute
City
Rotterdam
ZIP/Postal Code
3015 GD
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Hospital Del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital General Universitario Vall D Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Clinic Barcelona Main
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital de La Santa Creu I Sant Pau
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Individual Site Status
Recruiting
Facility Name
Ico Institut Catala D Oncologia
City
Barcelona
ZIP/Postal Code
08908
Country
Spain
Individual Site Status
Recruiting
Facility Name
Ico Girona Hospital Universitari de Girona Dr Josep Trueta
City
Girona
ZIP/Postal Code
17007
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital General Universitario Gregorio Maranon
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Ramon Y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Hm Sanchinarro
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Individual Site Status
Recruiting
Facility Name
Clinica Universidad de Navarra (Cun)
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital General de Catalunya
City
Sant Cugat Del Valles
ZIP/Postal Code
08190
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Virgen Del Rocio
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital General Universitario de Valencia
City
Valencia
ZIP/Postal Code
46014
Country
Spain
Individual Site Status
Recruiting
Facility Name
Addenbrooke'S Hospital
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Velindre Cancer Centre
City
Cardiff
ZIP/Postal Code
CF14 2TL
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
St James'S University Hospital
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Guys Hospital
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
The Royal Marsden Nhs Foundation Trust - Sutton
City
London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
The Royal Marsden Nhs Foundation Trust - Chelsea
City
London
ZIP/Postal Code
SW36JJ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
The Christie Nhs Foundation Trust Uk
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
The Clatterbridge Cancer Centre
City
Wirral
ZIP/Postal Code
CH63 4JY
Country
United Kingdom
Individual Site Status
Not yet recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency
IPD Sharing Time Frame
Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
IPD Sharing Access Criteria
Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.
IPD Sharing URL
https://www.incyte.com/our-company/compliance-and-transparency

Learn more about this trial

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

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