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Tyrosine Kinase Inhibitor

Infigratinib for Low Grade Glioma (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 24 months

Awards & highlights

NEWEL Trial Summary

This trial is testing a drug called Infigratinib to see what dose is best for children and if it is safe and effective.

Eligible Conditions

Low Grade Glioma
Solid Tumors
Brain Tumor

NEWEL Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

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

Phase 1b Dose Limiting Toxicity (DLT) rate

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

Secondary outcome measures

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

+31 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

Colitis

Pyrexia

Cancer pain

Femur fracture

Constipation

Rash maculo-papular

Intestinal perforation

Vomiting

Fatigue

Hypertension

Cardiac failure

Alanine aminotransferase increased

Gastrointestinal haemorrhage

Aphasia

Blood alkaline phosphatase increased

Pain in extremity

Cardiac arrest

100%

80%

60%

40%

20%

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

NEWEL 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Labcorp Drug Development, Inc.Industry Sponsor

10 Previous Clinical Trials

537 Total Patients Enrolled

Labcorp Corporation of America Holdings, IncIndustry Sponsor

18 Previous Clinical Trials

4,226 Total Patients Enrolled

Labcorp Drug Development IncIndustry Sponsor

16 Previous Clinical Trials

3,186 Total Patients Enrolled

Frequently Asked Questions

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

Can patients still join this clinical trial?

"Unfortunately, this particular clinical trial is not looking for new patients right now. The trial was originally posted on October 1st, 2022 and was most recently updated on August 2nd, 2022. Although this study isn't recruiting, there are 3850 other trials that are currently enrolling participants."

Answered by AI

In how many different hospitals is this medical study being conducted today?

"This trial is being conducted at nine locations, including MCH in Hamilton, the Brain tumor Institute at Children's National Hospital in Washington, Lucile Packard Children's Hospital at Stanford University Medical Center in Palo Alto, and six other sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2021. "Study With Infigratinib in Subjects With Advanced Solid and CNS Tumors or Recurrent or Progressive Low-Grade Glioma With Selected FGFR1-3 Alterations". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05222165.