Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Waitlist Available
Sponsor: Incyte Corporation
No Placebo Group
Prior Safety Data
Breakthrough Therapy
Approved in 1 jurisdiction
Trial Summary
What is the purpose of this trial?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
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.Inclusion Criteria
My cancer has a specific FGFR gene change that can be targeted by treatment.
I can provide a tumor block or at least 15 slides from my cancer biopsy.
I can care for myself but may need occasional help.
My MRI shows my condition worsened after treatment and no other treatments are likely to help.
My brain tumor has come back and is confirmed by tests.
Exclusion Criteria
I am taking more than 4 mg of dexamethasone daily.
I have previously been treated with an FGFR inhibitor.
My cancer has spread to the lining of my brain and spinal cord.
I have another cancer that is getting worse or needs treatment.
I am eligible for surgery that could potentially cure my condition.
I am not currently receiving any cancer treatments.
Treatment Details
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.
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.
Pemigatinib is already approved in United States for the following indications:
🇺🇸 Approved in United States as Pemazyre for:
- Unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement
- Relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with FGFR1 rearrangement
Find a clinic near you
Research locations nearbySelect from list below to view details:
Columbia University Irving Medical CenterNew York, NY
Providence Medical FoundationFullerton, CA
Usc Norris Comprehensive Cancer CenterLos Angeles, CA
Providence St Joseph Hospital Orange Center For Cancer Prevention and TreatmentSanta Monica, CA
More Trial Locations
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Who is running the clinical trial?
Incyte CorporationLead Sponsor