Infigratinib in Recurrent High-Grade Glioma Patients

Phase < 1

Waitlist Available

Research Sponsored by Nader Sanai

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 60 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will enroll up to 20 participants with recurrent high-grade glioma who are scheduled for resection. Participants will be administered infigratinib prior to surgical resection of their tumor.

Eligible Conditions

Brain Tumor
Solid Tumors
Glioblastoma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 60 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 60 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 60 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

Expansion Cohort: 6-month Progression-free survival

Phase 0: Concentration of infigratinib in CSF

Phase 0: Concentration of infigratinib in enhancing and non-enhancing tumor tissue

+1 more

Secondary study objectives

Incidence of drug-related toxicity

Incidence of treatment-emergent adverse events

Number of Adverse Events

+3 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Arm 1Experimental Treatment1 Intervention

Phase 0: 125 mg of infigratinib administered orally for 7 days prior to surgical resection. Expansion Cohort: 125 mg of infigratinib administered orally for 21 days of a 28-day treatment cycles.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Infigratinib

2020

Completed Phase 2

~20

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