Pemigatinib for Glioblastoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Glioblastoma+1 MorePemigatinib - Drug
Eligibility
18 - 99
All Sexes
What conditions do you have?
Select

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

Effectiveness Progress

1 of 3

Similar Trials

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

Safety Progress

2 of 3
This is further along than 68% of similar trials

Similar Trials

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: Drug
Cohort B: primary CNS tumors and adult-type diffuse gliomas
Drug
Experimental Group · 1 Intervention: Pemigatinib · Intervention Types: Drug
Cohort C: GBM or recurrent primary CNS tumors
Drug
Experimental Group · 1 Intervention: Pemigatinib · Intervention Types: Drug
Treatment
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 York100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Northwell Health100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%