Study 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.
Eligible Conditions
- Glioblastoma
- Adult-type Diffuse Glioma
Treatment Effectiveness
Study Objectives
2 Primary · 9 Secondary · Reporting Duration: Up to 3 months
Up to 3 months
Cohort A: Overall Response Rate (ORR)
Cohort B: ORR
Cohort C: ORR
Cohorts A and B combined: ORR
Cohorts A and B: Disease Control Rate (DCR)
Cohorts A and B: Duration of Response (DOR)
Cohorts A and B: Overall Survival (OS)
Cohorts A and B: Progression-Free Survival (PFS)
Cohorts A, B and C: ORR
Cohorts A, B, and C combined: ORR
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Trial Safety
Trial Design
3 Treatment Groups
Cohort A: IDH-wild-type GBM
1 of 3
Cohort B: primary CNS tumors and adult-type diffuse gliomas
1 of 3
Cohort C: GBM or recurrent primary CNS tumors
1 of 3
Experimental Treatment
189 Total Participants · 3 Treatment Groups
Primary Treatment: Pemigatinib · No Placebo Group · Phase 2
Cohort A: IDH-wild-type GBM
Drug
Experimental Group · 1 Intervention: Pemigatinib · Intervention Types: DrugCohort B: primary CNS tumors and adult-type diffuse gliomas
Drug
Experimental Group · 1 Intervention: Pemigatinib · Intervention Types: DrugCohort C: GBM or recurrent primary CNS tumors
Drug
Experimental Group · 1 Intervention: Pemigatinib · Intervention Types: DrugTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pemigatinib
2017
Completed Phase 2
~210
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 3 months
Who is running the clinical trial?
Incyte CorporationLead Sponsor
315 Previous Clinical Trials
46,331 Total Patients Enrolled
4 Trials studying Glioblastoma
437 Patients Enrolled for Glioblastoma
Luisa Veronese, MDStudy DirectorIncyte Corporation
1 Previous Clinical Trials
125 Total Patients Enrolled
Eligibility Criteria
Age 18 - 99 · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have a tumor lesion that is radiographically measurable.
You have a life expectancy ≥ 12 weeks.
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.
You have recurrent GBM or other adult-type, diffuse glioma or circumscribed astrocytic tumors.
You have a WHO grade 4 astrocytoma or IDH-mutant GBM, or an IDH-mutant astrocytoma or IDH-mutant and 1p/19q codeleted oligodendroglioma, or a pilocytic astrocytoma or IDH-mutant and 1p/19q codeleted oligodendroglioma that is recurrent with a known or likely FGFR 1-3 activating mutation.
Who else is applying?
What state do they live in?
| New York | 100.0% |
How old are they?
| 18 - 65 | 100.0% |
What site did they apply to?
| Northwell Health | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 100.0% |
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Conditions
Cancer Related
Treatments