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Tyrosine Kinase Inhibitor

Infigratinib for Brain Tumor

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

Study 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
  • Glioblastoma

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
Incidence of drug-related toxicity
Incidence of treatment-emergent adverse events
Number of Adverse Events
+3 more

Side effects data

From 2023 Phase 2 trial • 158 Patients • NCT02159066
23%
Hypoalbuminaemia
23%
Oedema peripheral
23%
Anaemia
15%
Diarrhoea
15%
Blood creatine increased
15%
Nausea
15%
Visual field defect
15%
Urinary tract infection
15%
Gamma-glutamyltransferase increased
15%
Blood creatine phosphokinase increased
15%
Blood creatinine increased
8%
Fatigue
8%
Aphasia
8%
Rash maculo-papular
8%
Colitis
8%
Gastrointestinal haemorrhage
8%
Cancer pain
8%
Constipation
8%
Hypertension
8%
Pyrexia
8%
Intestinal perforation
8%
Pain in extremity
8%
Vomiting
8%
Femur fracture
8%
Cardiac failure
8%
Alanine aminotransferase increased
8%
Blood alkaline phosphatase increased
8%
Cardiac arrest
100%
80%
60%
40%
20%
0%
Study treatment Arm
Part II: Encorafenib + Binimetinib + Capmatinib
Part I: Encorafenib + Binimetinib (Naive)
Part I: Encorafenib + Binimetinib (Non-naive)
Part II: Encorafenib + Binimetinib + Ribociclib
Part II: Encorafenib + Binimetinib + Infigratinib
Part II: Encorafenib + Binimetinib + Buparlisib

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

Find a Location

Who is running the clinical trial?

Ivy Brain Tumor CenterOTHER
11 Previous Clinical Trials
820 Total Patients Enrolled
QED TherapeuticsUNKNOWN
Nader SanaiLead Sponsor
8 Previous Clinical Trials
321 Total Patients Enrolled
~1 spots leftby Jun 2025
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