Study With Infigratinib in Subjects With Advanced Solid and CNS Tumors or Recurrent or Progressive Low-Grade Glioma With Selected FGFR1-3 Alterations (NEWEL Trial)

Phase 1 & 2

Waitlist Available

Led By Alberto Broniscer, MD

Research Sponsored by Helsinn Healthcare SA

Eligibility Criteria Checklist

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

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 months

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial is testing Infigratinib, a medication that targets specific genetic changes in cancer cells. It focuses on pediatric patients with advanced tumors or recurrent/progressive Low-Grade Glioma with FGFR1-3 alterations. The drug works by blocking proteins that help cancer cells grow and survive. Infigratinib is recently approved in the USA for treating cholangiocarcinoma with FGFR2 fusion or rearrangement.

Eligible Conditions

Brain Tumor
Solid Tumors

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 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

Phase 1b Dose Limiting Toxicity (DLT) rate

Phase 2 Objective Response Rate (ORR) by Blinded Independent Central Review (BICR)

Secondary study objectives

Phase 1b Best Overall Response (BOR) assessed by Investigator

Phase 1b Best change in tumor size assessed by Investigator

Phase 1b Disease Control Rate (DCR) assessed by Investigator

+13 more

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

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: Infigratinib (BGJ398)Experimental Treatment1 Intervention

Generic name: infigratinib. Dosage forms: 18mg and 25mg sprinkle capsules and 25mg, 75mg, 100mg capsules. Phase 1b Three dose levels escalation until RP2D is determined. Phase 2 * Pediatric patients: dose defined in the phase 1b (RP2D); * Adults: 125 mg. Frequency: once daily for 21 days in each 28-day treatment cycle. Duration: Treatment duration will last up to 26 cycles unless progression, death or unacceptable toxicity occur.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Infigratinib

FDA approved

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