Infigratinib in Recurrent High-Grade Glioma Patients

Recruiting at2 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Waitlist Available

Sponsor: Nader Sanai

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is an open-label, multicenter, Phase 0 trial that will enroll up to 20 participants with recurrent high-grade glioma with FGFR1 K656E or FGFR3 K650E mutation or FGFR3-TACC3 translocation which are scheduled for resection. In the lead-in cohort, a total of 20 participants will be enrolled into the proposed phase 0 clinical trial. Participants will be administered infigratinib prior to surgical resection of their tumor.

Research Team

Eligibility Criteria

Inclusion Criteria

Adequate bone marrow function: absolute neutrophil count ≥1,000/mcL, Platelets (at time of surgery) ≥100,000/mcL, hemoglobin ≥8.0 g/dL Participants may receive erythrocyte transfusions to achieve this hemoglobin level at the discretion of the investigator.

For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 3 months after the end of treatment administration.

For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner and for an additional 1 month after the end of treatment administration. A condom is required to be used also by vasectomized men as well as during intercourse with a male partner to prevent delivery of the drug via seminal fluid.

Exclusion Criteria

Have a history of liver transplant.

CTCAE (v5.0) Grade ≥2 hearing loss.

Have clinically significant cardiac disease including any of the following: Known congestive heart failure requiring treatment (New York Heart Association Grade ≥2), LVEF <50% or local lower limit of normal as determined by MUGA scan or echocardiogram (ECHO), or uncontrolled hypertension (refer to the European Society of Cardiology and European Society of Hypertension guidelines [Williams et al 2018]).

Treatment Details

Interventions

• Infigratinib (Tyrosine Kinase Inhibitor)

Participant Groups

Group I: Arm 1 Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Nader Sanai

Lead Sponsor

Trials

11

Recruited

440+

Ivy Brain Tumor Center

Collaborator

Trials

12

Recruited

910+

QED Therapeutics

Collaborator

Trials

1

Recruited

7+

Barrow Neurological Institute

Collaborator

Trials

27

Recruited

7,100+