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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
Ability to swallow oral medications.
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

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You are able to swallow pills or tablets.

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%
Blood creatine increased
15%
Visual field defect
15%
Gamma-glutamyltransferase increased
15%
Urinary tract infection
15%
Nausea
15%
Diarrhoea
15%
Blood creatine phosphokinase increased
15%
Blood creatinine increased
8%
Colitis
8%
Pyrexia
8%
Cancer pain
8%
Femur fracture
8%
Constipation
8%
Rash maculo-papular
8%
Cardiac arrest
8%
Intestinal perforation
8%
Vomiting
8%
Cardiac failure
8%
Fatigue
8%
Alanine aminotransferase increased
8%
Hypertension
8%
Gastrointestinal haemorrhage
8%
Aphasia
8%
Blood alkaline phosphatase increased
8%
Pain in extremity
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.

Find a Location

Who is running the clinical trial?

Ivy Brain Tumor CenterOTHER
10 Previous Clinical Trials
370 Total Patients Enrolled
QED TherapeuticsUNKNOWN
Nader SanaiLead Sponsor
8 Previous Clinical Trials
321 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the primary objective of this investigation?

"This clinical trial will gauge its efficacy over a span of 7 days and 8 hours following dosage. The primary metric is the concentration of infigratinib in plasma (0-24H). Secondary outcomes include percentage of pERK+, MIB-1+ and Cleaved Caspase 3+ cells from surgical tissue, incidence of drug-related toxicity, and number/incidence death rate."

Answered by AI

Is this experiment continuing to accept new participants?

"Clinicaltrials.gov currently lists this trial as actively searching for participants, with a start date of July 21st 2020 and the most recent update being on March 10th 2022."

Answered by AI

How many people have registered to participate in this clinical study?

"Affirmative. Online records from clinicaltrials.gov confirm that this medical trial, which was first published on July 21st 2020, is actively recruiting participants. 20 patients need to be enrolled at 3 different sites for the research project to continue as planned."

Answered by AI

In what clinical situations is Infigratinib routinely recommended?

"Infigratinib is a viable treatment modality for those with unresectable, metastatic cholangiocarcinomas who have the fgfr2 protein present in their human advance directives."

Answered by AI

Is this the inaugural attempt to research this particular topic?

"Since 2014, Infigratinib has been subject to numerous studies. The process began with a Pfizer-funded study involving 160 participants in that same year. This research was successful enough for Phase 2 drug approval, and since then 11 active trials have taken place across 172 cities and 19 countries."

Answered by AI

Have there been prior experiments associated with Infigratinib?

"Currently, there are 11 studies concerning Infigratinib with two in their final phase. Columbus Ohio is the focal point for most of these trials; however, 392 different facilities across the globe offer access to this treatment."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Infigratinib in Recurrent High-Grade Glioma Patients
Nader Sanai 2020. "Infigratinib in Recurrent High-Grade Glioma Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04424966.
~1 spots leftby Apr 2025
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