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Tyrosine Kinase Inhibitor

Pemigatinib for Brain Tumor (FIGHT-209 Trial)

Phase 2
Waitlist Available
Research Sponsored by Incyte Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
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
Must not have
Dexamethasone (or equivalent) > 4 mg daily at the time of study registration
Prior receipt of an FGFR inhibitor
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 months
Awards & highlights

Summary

This trial is testing a drug called pemigatinib for people with recurrent glioblastoma or other primary brain tumors. Pemigatinib will be given daily on a 2-week on, 1-week off schedule. The trial will enroll about 82 people in each of 3 cohorts.

Who is the study for?
This trial is for people with specific brain tumors like recurrent glioblastoma or other nervous system tumors that have an FGFR1-3 gene mutation. Participants should be able to perform daily activities at a reasonable level (Karnofsky status ≥ 60), expect to live at least 12 more weeks, and not plan on having children during the trial. They can't join if they've taken certain cancer drugs recently, had prior treatment with FGFR inhibitors, are candidates for curative surgery, need high doses of steroids, or have another progressing cancer.Check my eligibility
What is being tested?
The study tests Pemigatinib's effectiveness and safety in patients with brain tumors harboring FGFR mutations. It involves two cohorts receiving Pemigatinib under a schedule of two weeks on therapy followed by one week off as long as it benefits them without withdrawal criteria being met.See study design
What are the potential side effects?
While the side effects specific to Pemigatinib aren't listed here, similar medications often cause issues like fatigue, digestive problems, changes in blood tests reflecting liver function, dry skin or nail changes; some may also affect eyesight due to corneal or retinal disorders.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer has a specific FGFR gene change that can be targeted by treatment.
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I can provide a tumor block or at least 15 slides from my cancer biopsy.
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I can care for myself but may need occasional help.
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My MRI shows my condition worsened after treatment and no other treatments are likely to help.
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My brain tumor has come back and is confirmed by tests.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am taking more than 4 mg of dexamethasone daily.
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I have previously been treated with an FGFR inhibitor.
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My cancer has spread to the lining of my brain and spinal cord.
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I have another cancer that is getting worse or needs treatment.
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I am eligible for surgery that could potentially cure my condition.
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I am not currently receiving any cancer treatments.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Cohort A: Overall Response Rate (ORR)
Secondary outcome measures
Cohort B : ORR
Cohorts A and B : Duration Of Response (DOR)
Cohorts A and B combined: ORR
+4 more

Side effects data

From 2022 Phase 2 trial • 147 Patients • NCT02924376
59%
Alopecia
56%
Hyperphosphataemia
54%
Diarrhoea
46%
Fatigue
43%
Stomatitis
43%
Constipation
42%
Nausea
42%
Dysgeusia
39%
Dry mouth
35%
Dry eye
34%
Arthralgia
32%
Vomiting
31%
Decreased appetite
28%
Dry skin
26%
Hypophosphataemia
25%
Back pain
24%
Pain in extremity
21%
Palmar-plantar erythrodysaesthesia syndrome
20%
Abdominal pain
19%
Headache
19%
Urinary tract infection
19%
Weight decreased
18%
Dizziness
18%
Epistaxis
15%
Oedema peripheral
15%
Hypercalcaemia
15%
Anaemia
15%
Dehydration
14%
Myalgia
14%
Asthenia
13%
Dyspepsia
12%
Insomnia
12%
Nasal dryness
12%
Gastrooesophageal reflux disease
12%
Pruritus
12%
Onychomadesis
11%
Rash
11%
Blood alkaline phosphatase increased
11%
Nail discolouration
11%
Alanine aminotransferase increased
10%
Muscle spasms
10%
Pyrexia
10%
Abdominal pain upper
10%
Nail dystrophy
10%
Oropharyngeal pain
10%
Trichiasis
9%
Dyspnoea
9%
Vitamin D deficiency
9%
Onycholysis
9%
Cough
8%
Hyperbilirubinaemia
8%
Hypertension
8%
Hypokalaemia
8%
Abdominal distension
8%
Paronychia
8%
Onychoclasis
8%
Blood creatinine increased
8%
Aspartate aminotransferase increased
7%
Growth of eyelashes
7%
Fall
7%
Punctate keratitis
7%
Erythema
7%
Nasal congestion
7%
Platelet count decreased
6%
Lacrimation increased
6%
Conjunctivitis
6%
Nail disorder
6%
Nasopharyngitis
6%
Neuropathy peripheral
6%
Skin exfoliation
6%
Taste disorder
6%
Upper respiratory tract infection
6%
Cataract
6%
Eye pain
6%
Chills
6%
Blood bilirubin increased
6%
Depression
6%
Hyponatraemia
6%
Ocular hyperaemia
6%
Influenza like illness
5%
Dysphagia
5%
Vitreous floaters
5%
Cystitis
5%
Cholangitis
5%
Flank pain
5%
Hypotension
5%
Acute kidney injury
5%
Muscular weakness
5%
Neck pain
5%
Oral candidiasis
4%
Hyperuricaemia
4%
Weight increased
4%
Pain
4%
Ascites
4%
Skin fissures
4%
Lymphocyte count decreased
4%
Keratitis
3%
Breast pain
3%
Activated partial thromboplastin time prolonged
3%
Dyspnoea exertional
3%
Tinnitus
3%
Blood parathyroid hormone decreased
3%
Pollakiuria
3%
Bronchitis
3%
Cholangitis infective
3%
Non-cardiac chest pain
2%
Hypoalbuminaemia
2%
Rash maculo-papular
2%
Sepsis
2%
Decubitus ulcer
2%
Hypocalcaemia
2%
Blood 1,25-dihydroxycholecalciferol increased
2%
Bacteraemia
2%
Failure to thrive
2%
Electrocardiogram QT prolonged
2%
Pharyngitis
2%
Trichomegaly
2%
Palpitations
2%
Tachycardia
2%
Dysuria
2%
Hyperglycaemia
2%
Dysphonia
2%
Device occlusion
2%
Small intestinal obstruction
2%
Blood 1,25-dihydroxycholecalciferol decreased
2%
Chronic kidney disease
2%
Biliary obstruction
2%
Pleural effusion
2%
Pneumonia
2%
Hypercholesterolaemia
1%
Septic shock
1%
Oesophageal varices haemorrhage
1%
Complication associated with device
1%
Micturition urgency
1%
Intestinal obstruction
1%
Jaundice
1%
Hyperkalaemia
1%
Thrombosis
1%
Retinal detachment
1%
Enterobacter bacteraemia
1%
Kidney infection
1%
Biliary tract infection
1%
Seizure
1%
Prostate cancer
1%
Skin infection
1%
Pseudomonal bacteraemia
1%
Varices oesophageal
1%
Oral herpes
1%
Clostridium difficile infection
1%
Device leakage
1%
Gynaecomastia
1%
Somnolence
1%
Catheter site infection
1%
Gastrointestinal haemorrhage
1%
Haematemesis
1%
Hydronephrosis
1%
Optic ischaemic neuropathy
1%
Pneumonitis
1%
Transaminases increased
1%
C-reactive protein increased
1%
Cancer pain
1%
Candida infection
1%
Confusional state
1%
Herpes zoster
1%
Musculoskeletal pain
1%
Psoriasis
1%
Blood chloride decreased
1%
Cerebrovascular accident
1%
Malignant biliary obstruction
1%
Melaena
1%
Paraplegia
1%
Pneumonia aspiration
1%
Pneumonia pneumococcal
1%
Syncope
1%
Haemorrhoids
1%
Sinus pain
1%
Urinary tract pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort A: FGFR2 Rearrangements or Fusions
Cohort B: FGF/FGFR Alterations Other Than FGFR2 Rearrangements or Fusions
Cohort C: Negative for FGF/FGFR Alterations
Other
Total

Trial Design

2Treatment groups
Experimental Treatment
Group I: Cohort B: Other gliomas other than GBMExperimental Treatment1 Intervention
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
Group II: Cohort A: IDH-wild-type GBMExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pemigatinib
2022
Completed Phase 2
~250

Find a Location

Who is running the clinical trial?

Incyte CorporationLead Sponsor
373 Previous Clinical Trials
55,696 Total Patients Enrolled
5 Trials studying Glioblastoma
459 Patients Enrolled for Glioblastoma
Victoria Ebiana, MDStudy DirectorIncyte Corporation
Luisa Veronese, MDStudy DirectorIncyte Corporation
1 Previous Clinical Trials
8 Total Patients Enrolled

Media Library

Pemigatinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05267106 — Phase 2
Glioblastoma Research Study Groups: Cohort B: Other gliomas other than GBM, Cohort A: IDH-wild-type GBM
Glioblastoma Clinical Trial 2023: Pemigatinib Highlights & Side Effects. Trial Name: NCT05267106 — Phase 2
Pemigatinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05267106 — Phase 2
~11 spots leftby Nov 2024
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