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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

No Placebo-Only Group

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Cohort A: Overall Response Rate (ORR)

Secondary study objectives

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%

Gastrooesophageal reflux disease

12%

Insomnia

12%

Nasal dryness

12%

Pruritus

12%

Onychomadesis

11%

Blood alkaline phosphatase increased

11%

Rash

11%

Nail discolouration

11%

Alanine aminotransferase increased

10%

Muscle spasms

10%

Pyrexia

10%

Abdominal pain upper

10%

Nail dystrophy

10%

Oropharyngeal pain

10%

Trichiasis

Dyspnoea

Vitamin D deficiency

Onycholysis

Cough

Abdominal distension

Hyperbilirubinaemia

Hypertension

Hypokalaemia

Paronychia

Onychoclasis

Blood creatinine increased

Aspartate aminotransferase increased

Growth of eyelashes

Fall

Punctate keratitis

Erythema

Nasal congestion

Platelet count decreased

Conjunctivitis

Lacrimation increased

Nail disorder

Nasopharyngitis

Neuropathy peripheral

Skin exfoliation

Taste disorder

Upper respiratory tract infection

Cataract

Eye pain

Chills

Blood bilirubin increased

Depression

Hyponatraemia

Ocular hyperaemia

Influenza like illness

Dysphagia

Vitreous floaters

Cystitis

Cholangitis

Flank pain

Hypotension

Acute kidney injury

Muscular weakness

Neck pain

Oral candidiasis

Hyperuricaemia

Pain

Weight increased

Ascites

Skin fissures

Lymphocyte count decreased

Keratitis

Activated partial thromboplastin time prolonged

Breast pain

Dyspnoea exertional

Tinnitus

Blood parathyroid hormone decreased

Pollakiuria

Bronchitis

Cholangitis infective

Non-cardiac chest pain

Decubitus ulcer

Sepsis

Blood 1,25-dihydroxycholecalciferol increased

Electrocardiogram QT prolonged

Hypoalbuminaemia

Failure to thrive

Bacteraemia

Hypocalcaemia

Palpitations

Pharyngitis

Rash maculo-papular

Tachycardia

Trichomegaly

Dysuria

Hyperglycaemia

Dysphonia

Device occlusion

Small intestinal obstruction

Blood 1,25-dihydroxycholecalciferol decreased

Chronic kidney disease

Biliary obstruction

Pleural effusion

Pneumonia

Hypercholesterolaemia

Prostate cancer

Skin infection

Retinal detachment

Septic shock

Thrombosis

Biliary tract infection

Complication associated with device

Enterobacter bacteraemia

Intestinal obstruction

Hyperkalaemia

Jaundice

Kidney infection

Oesophageal varices haemorrhage

Micturition urgency

Seizure

Pseudomonal bacteraemia

Varices oesophageal

Oral herpes

Clostridium difficile infection

Device leakage

Gynaecomastia

Somnolence

Catheter site infection

Gastrointestinal haemorrhage

Haematemesis

Hydronephrosis

Optic ischaemic neuropathy

Pneumonitis

Transaminases increased

C-reactive protein increased

Cancer pain

Candida infection

Confusional state

Herpes zoster

Musculoskeletal pain

Psoriasis

Blood chloride decreased

Cerebrovascular accident

Malignant biliary obstruction

Melaena

Paraplegia

Pneumonia aspiration

Pneumonia pneumococcal

Syncope

Haemorrhoids

Sinus pain

Urinary tract pain

100%

80%

60%

40%

20%

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 11Eligibility criteria met