GlioblastomaPhase 2FIGHT-209NCT05267106
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
A Phase 2 study testing Pemigatinib in people with Glioblastoma and Adult-type Diffuse Gliomas, run by Incyte Corporation at 79 sites in 9 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Glioblastoma, Adult-type Diffuse Gliomas
- What is being tested?
- Pemigatinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 79 sitesin 9 countries
- Study dates
- 20 May 2022to 17 Dec 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
79 sites in 9 countries.
79 sites in 9 countries
United States32 sites
Valkyrie Clinical Trials
Beverly Hills, California, 90211
Tennessee Oncology
Chattanooga, Tennessee, 37403
University of Illinois Hospital & Health Sciences System
Chicago, Illinois, 60612
UC Health At Cincinnati Va Medical Center
Cincinnati, Ohio, 45229
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Baylor University Medical Center
Dallas, Texas, 75246
City of Hope National Medical Center
Duarte, California, 91010
Providence Medical Foundation
Fullerton, California, 92835
East Carolina University
Greenville, North Carolina, 27834
Houston Methodist Hospital
Houston, Texas, 77030
University of Iowa Hospital and Clinics
Iowa City, Iowa, 52242
Baptist Md Anderson Cancer Center
Jacksonville, Florida, 32207
Northwell Health
Lake Success, New York, 11042
Usc Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Miami Cancer Institute
Miami, Florida, 33176
University of Minnesota Health Clinics and Surgery Center
Minneapolis, Minnesota, 55455
Tennessee Oncology
Nashville, Tennessee, 37203
Yale Cancer Center
New Haven, Connecticut, 06510-3220
University Medical Center New Orleans
New Orleans, Louisiana, 70112
Columbia University Irving Medical Center
New York, New York, 10032
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Orlando Health Cancer Institute Downtown Orlando
Orlando, Florida, 32806
University of Pennsylvania Hospital
Philadelphia, Pennsylvania, 19104
University of Pittsburgh Medical Center Health System
Pittsburgh, Pennsylvania, 15232
Stanford Neuroscience Health Center
Sacramento, California, 94304
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
Sharp Memorial Hospital
San Diego, California, 92123
University of California San Francisco
San Francisco, California, 94143
Providence St Joseph Hospital Orange Center For Cancer Prevention and Treatment
Santa Monica, California, 90404
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
H. Lee Moffitt Cancer Center and Research Institute Hospital
Tampa, Florida, 33612
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157
Spain14 sites
Hospital Del Mar
Barcelona, 08003
Hospital General Universitario Vall D Hebron
Barcelona, 08035
Hospital Clinic Barcelona Main
Barcelona, 08036
Hospital de La Santa Creu I Sant Pau
Barcelona, 08041
Ico Girona Hospital Universitari de Girona Dr Josep Trueta
Girona, 17007
Ico Institut Catala D Oncologia
L'Hospitalet de Llobregat, 08908
Hospital General Universitario Gregorio Maranon
Madrid, 28007
Hospital Universitario Ramon Y Cajal
Madrid, 28034
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital Universitario Hm Sanchinarro
Madrid, 28050
Clinica Universidad de Navarra (Cun)
Pamplona, 31008
Hospital General de Catalunya
Sant Cugat del Vallès, 08190
Hospital Universitario Virgen Del Rocio
Seville, 41013
Hospital General Universitario de Valencia
Valencia, 46014
United Kingdom8 sites
Addenbrooke'S Hospital
Cambridge, CB2 0QQ
Velindre Cancer Centre
Cardiff, CF14 2TL
St James'S University Hospital
Leeds, LS9 7TF
Guys Hospital
London, SE1 9RT
The Royal Marsden Nhs Foundation Trust - Sutton
London, SW3 6JJ
The Royal Marsden Nhs Foundation Trust - Chelsea
London, SW36JJ
The Christie Nhs Foundation Trust Uk
Manchester, M20 4BX
The Clatterbridge Cancer Centre
Metropolitan Borough of Wirral, CH63 4JY
Italy6 sites
Ospedale Bellaria
Bologna, 40139
Istituto Di Ricovero E Cura A Carattere Scientifico (Irccs) Ospedale San Raffaele
Milan, 20132
Iov - Istituto Oncologico Veneto Irccs
Padova, 35128
A.S.L. Napoli 1 Centro Ospedale Del Mare
Ponticelli, 80147
Irccs Istituto Clinico Humanitas
Rozzano, 20089
Azienda Ospedaliero Universitaria Citta Della Salute E Della Scienza
Torino, 10124
Japan6 sites
University of Tokyo Hospital
Bunkyō City, 113-8655
National Cancer Center Hospital
Chūōku, 104-0045
Kyushu University Hospital
Fukuoka, 812-8582
Kyoto University Hospital
Kyoto, 606-8507
Nagoya University Hospital
Nagoya, 466-8560
Tohoku University Hospital
Sendai, 980-8574
France4 sites
Chru de Lille Hopital Claude Huriez
Lille, 59037
Chu Hopital de La Timone
Marseille, 13005
Hospital Universitaire Pitie-Salpetriere
Paris, 75013
Universitaire Du Cancer de Toulouse Institut Claudius Regaud Iuct-Oncopole
Toulouse, 31059
Germany4 sites
Universitatsklinikum Bonn Aoer
Bonn, 53127
Klinikum Der Johann Wolfgang Goethe University
Frankfurt, 60528
Universitaetsklinikum Heidelberg
Heidelberg, 69120
University Hospital Tuebingen
Tübingen, 72076
Denmark3 sites
Aalborg Universitets Hospital
Aalborg, 09000
Rigshospitalet Uni of Hospital of Copenhagen
Copenhagen, 02100
Odense University Hospital
Odense C, 05000
Netherlands2 sites
Netherlands Cancer Institute Antoni Van Leeuwenhoek Ziekenhuis
Amsterdam, 1066 CX
Erasmus Mc Cancer Institute
Rotterdam, 3015 GD
About this study
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)
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.
- Conditions
- Glioblastoma, Adult-type Diffuse Gliomas
- Being tested
- Pemigatinib
- 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
- Medical subject headings
- Glioblastoma, Glioma, Oligodendroglioma, Central Nervous System Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PemigatinibDrug
Also called NCB054828
13.5mg tablet taken every morning (unless otherwise directed) for 2 weeks and then 1 week off.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A: IDH-wild-type GBM | Experimental | 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. Receives: Drug: Pemigatinib |
| Cohort B: Other gliomas other than GBM | Experimental | 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 Receives: Drug: Pemigatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR) in Participants With Recurrent Glioblastoma Based on Independent Central Review
ORR was defined as the percentage of participants who achieved a best overall response of complete response (CR) or partial response (PR) based on Response Assessment in Neuro-Oncology (RANO) as determined by an independent centralized radiological review committee. CR requires all of the following: disappearance of all enhancing measurable/nonmeasurable disease sustained for ≥4 weeks; no new lesions; stable/improved nonenhancing lesions; off corticosteroids/on physiologic replacement doses only and stable/improved clinically. PR requires all of the following: ≥50% decrease, compared with baseline, in the sum of products of perpendicular diameters of all measurable enhancing lesions sustained for ≥4 weeks; no progression of nonmeasurable disease; no new lesions; stable or improved nonenhancing lesions on same/lower dose of corticosteroids compared with baseline scan; on a corticosteroid dose not greater than the dose at time of baseline scan and stable/improved clinically.
Measured: up to 651 days
Secondary outcomes (10)
ORR in Participants With Recurrent Non-glioblastoma Central Nervous System Tumors Based on Independent Central Review
ORR was defined as the percentage of participants who achieved a best overall response of CR or PR based on RANO as determined by an independent centralized radiological review committee. CR requires all of the following: disappearance of all enhancing measurable/nonmeasurable disease sustained for ≥4 weeks; no new lesions; stable/improved nonenhancing lesions; off corticosteroids/on physiologic replacement doses only and stable/improved clinically. PR requires all of the following: ≥50% decrease, compared with baseline, in the sum of products of perpendicular diameters of all measurable enhancing lesions sustained for ≥4 weeks; no progression of nonmeasurable disease; no new lesions; stable or improved nonenhancing lesions on same/lower dose of corticosteroids compared with baseline scan; on a corticosteroid dose not greater than the dose at time of baseline scan and stable/improved clinically.
Measured: up to 784 days
Duration of Confirmed Response Based on Independent Central Review
Duration of response was defined as the time from the first assessment of confirmed CR or PR until progressive disease (PD) (according to RANO and assessed by an independent centralized radiological review committee) or death (whichever occurred first). Progression was defined by any of the following: ≥25% increase in the sum of the products of perpendicular diameters of enhancing lesions (compared with baseline if no decrease) on stable or increasing doses of corticosteroids; a significant increase in T2/FLAIR nonenhancing lesions on stable or increasing doses of corticosteroids compared with baseline scan or best response after initiation of therapy, not due to comorbid events; the appearance of any new lesions; clear progression of nonmeasurable lesions; or definite clinical deterioration not attributable to other causes apart from the tumor, or to decrease in corticosteroid dose.
Measured: up to 784 days
Duration of Unconfirmed Response Based on Independent Central Review
Duration of response was defined as the time from the first assessment of unconfirmed CR or PR until progressive disease (PD) (according to RANO and assessed by an independent centralized radiological review committee) or death (whichever occurred first). Progression was defined by any of the following: ≥25% increase in the sum of the products of perpendicular diameters of enhancing lesions (compared with baseline if no decrease) on stable or increasing doses of corticosteroids; a significant increase in T2/FLAIR nonenhancing lesions on stable or increasing doses of corticosteroids compared with baseline scan or best response after initiation of therapy, not due to comorbid events; the appearance of any new lesions; clear progression of nonmeasurable lesions; or definite clinical deterioration not attributable to other causes apart from the tumor, or to decrease in corticosteroid dose.
Measured: up to 784 days
ORR as Determined by Investigator Assessment
ORR was defined as the percentage of participants who achieved an unconfirmed best overall response of CR or PR based on RANO as determined by investigator assessment. CR requires all of the following: disappearance of all enhancing measurable/nonmeasurable disease sustained for ≥4 weeks; no new lesions; stable/improved nonenhancing lesions; off corticosteroids/on physiologic replacement doses only and stable/improved clinically. PR requires all of the following: ≥50% decrease, compared with baseline, in the sum of products of perpendicular diameters of all measurable enhancing lesions sustained for ≥4 weeks; no progression of nonmeasurable disease; no new lesions; stable or improved nonenhancing lesions on same/lower dose of corticosteroids compared with baseline scan; on a corticosteroid dose not greater than the dose at time of baseline scan and stable/improved clinically.
Measured: up to 784 days
Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug related. An AE could therefore have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug. A TEAE was defined as an AE reported for the first time or the worsening of a pre-existing event after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib.
Measured: up to 814 days
Number of Participants With Any ≥Grade 3 TEAE
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug related. A TEAE was defined as an AE reported for the first time or the worsening of a pre-existing event after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib. The severity of AEs was assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 Grades 1 through 5. Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated. Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent treatment indicated. Grade 5: fatal.
Measured: up to 814 days
Number of Participants With TEAEs Leading to Discontinuation of Pemigatinib, Pemigatinib Dose Interruption, and Pemigatinib Dose Reduction
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug related. An AE could therefore have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug. A TEAE was defined as an AE reported for the first time or the worsening of a pre-existing event after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib.
Measured: up to 814 days
Disease Control Rate (DCR) Based on Independent Central Review
DCR was defined as the percentage of participants who achieved a best overall response of CR, PR, or stable disease (SD) based on RANO as determined by an independent centralized radiological review committee. In the case of SD, measurements must have met the SD criteria after the date of the first dose at a minimum interval of 42 days. SD occurred if the participant didn't qualify for CR, PR, or PD and required the following: stable nonenhancing (T2/FLAIR) lesions on same or lower dose of corticosteroids compared with baseline scan and clinically stable status.
Measured: up to 784 days
Progression-free Survival (PFS) Based on Independent Central Review
PFS was defined as the time from the first dose until progressive disease (according to RANO and assessed by an independent centralized radiological review committee) or death (whichever occurred first). Progression was defined by any of the following: ≥25% increase in the sum of the products of perpendicular diameters of enhancing lesions (compared with baseline if no decrease) on stable or increasing doses of corticosteroids; a significant increase in T2/FLAIR nonenhancing lesions on stable or increasing doses of corticosteroids compared with baseline scan or best response after initiation of therapy, not due to comorbid events; the appearance of any new lesions; clear progression of nonmeasurable lesions; or definite clinical deterioration not attributable to other causes apart from the tumor, or to decrease in corticosteroid dose.
Measured: up to 784 days
Overall Survival
Overall survival was defined as the time from the first dose of study drug to death due to any cause.
Measured: up to 784 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2022
- Study start20 May 2022
- Primary completion17 Dec 2024
- Study completion17 Dec 2024
Why it stopped: Recruitment ceased after a pre-planned futility interim analysis indicated a low probability to confer a clinically meaningful improvement in objective response when compared to currently available therapies. There were no safety related concerns.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- More trials run by Incyte CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Incyte Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Victoria Ebiana, MD, Study director, Incyte Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05267106
- Sponsor's protocol ID
- INCB 54828-209
- Other IDs
- 2021-004740-24
- Acronym
- FIGHT-209
- Status last verified
- Nov 2025
- First submitted
- 15 Feb 2022
- Last updated
- 30 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05267106
- Acronym / sponsor ID
- FIGHT-209 / INCB 54828-209
- Conditions
- Glioblastoma, Adult-type Diffuse Gliomas
- Keywords
- glioblastoma, GBM, adult-type diffuse gliomas, gliomas, oligodendroglioma, FGFR1-3 Alteration, FGFR1-3 fusions, FGFR1-3 rearrangements
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment ceased after a pre-planned futility interim analysis indicated a low probability to confer a clinically meaningful improvement in objective response when compared to currently available therapies. There were no safety related concerns.
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Incyte CorporationIndustry (pharma, biotech, devices)
- Study start
- 20 May 2022 (actual)
- Primary completion
- 17 Dec 2024 (actual)
- Study completion
- 17 Dec 2024 (actual)
- First posted
- 4 Mar 2022 (actual)
- Results
- Posted 30 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Cohort A: IDH-wild-type GBM | Experimental | Drug: PemigatinibParticipants 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. |
| Cohort B: Other gliomas other than GBM | Experimental | Drug: PemigatinibParticipants 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 |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PemigatinibAlso: NCB05482813.5mg tablet taken every morning (unless otherwise directed) for 2 weeks and then 1 week off. | Drug | Cohort A: IDH-wild-type GBM, Cohort B: Other gliomas other than GBM |
Primary outcome
Objective Response Rate (ORR) in Participants With Recurrent Glioblastoma Based on Independent Central Review
Time frame: up to 651 days
ORR was defined as the percentage of participants who achieved a best overall response of complete response (CR) or partial response (PR) based on Response Assessment in Neuro-Oncology (RANO) as determined by an independent centralized radiological review committee. CR requires all of the following: disappearance of all enhancing measurable/nonmeasurable disease sustained for ≥4 weeks; no new lesions; stable/improved nonenhancing lesions; off corticosteroids/on physiologic replacement doses only and stable/improved clinically. PR requires all of the following: ≥50% decrease, compared with baseline, in the sum of products of perpendicular diameters of all measurable enhancing lesions sustained for ≥4 weeks; no progression of nonmeasurable disease; no new lesions; stable or improved nonenhancing lesions on same/lower dose of corticosteroids compared with baseline scan; on a corticosteroid dose not greater than the dose at time of baseline scan and stable/improved clinically.
10 secondary outcomes
ORR in Participants With Recurrent Non-glioblastoma Central Nervous System Tumors Based on Independent Central Review
Time frame: up to 784 days
Duration of Confirmed Response Based on Independent Central Review
Time frame: up to 784 days
Duration of Unconfirmed Response Based on Independent Central Review
Time frame: up to 784 days
ORR as Determined by Investigator Assessment
Time frame: up to 784 days
Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
Time frame: up to 814 days
Number of Participants With Any ≥Grade 3 TEAE
Time frame: up to 814 days
Number of Participants With TEAEs Leading to Discontinuation of Pemigatinib, Pemigatinib Dose Interruption, and Pemigatinib Dose Reduction
Time frame: up to 814 days
Disease Control Rate (DCR) Based on Independent Central Review
Time frame: up to 784 days
Progression-free Survival (PFS) Based on Independent Central Review
Time frame: up to 784 days
Overall Survival
Time frame: up to 784 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Victoria Ebiana, MD study director
Incyte Corporation
79 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pemigatinib in people with Glioblastoma and Adult-type Diffuse Gliomas, run by Incyte Corporation at 79 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 79 sites in United States, Spain, United Kingdom, Italy, Japan and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) in Participants With Recurrent Glioblastoma Based on Independent Central Review (time frame: up to 651 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2025.