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A Phase 1b/2, Multicenter, Open-Label Study of Oral Infigratinib in Pediatric Subjects With Advanced Solid and Central Nervous System (CNS) Tumors (Phase 1b) and in Subjects With Recurrent or Progressive Low-Grade Gliomas Harboring Selected FGFR1, FGFR2, or FGFR3 Alterations (Phase 2)

Trial Profile

A Phase 1b/2, Multicenter, Open-Label Study of Oral Infigratinib in Pediatric Subjects With Advanced Solid and Central Nervous System (CNS) Tumors (Phase 1b) and in Subjects With Recurrent or Progressive Low-Grade Gliomas Harboring Selected FGFR1, FGFR2, or FGFR3 Alterations (Phase 2)

Status: Withdrawn prior to enrolment
Phase of Trial: Phase I/II

Latest Information Update: 24 May 2023

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At a glance

  • Drugs Infigratinib (Primary)
  • Indications Glioma; Solid tumours
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms NEWEL
  • Sponsors Helsinn Healthcare SA

Most Recent Events

  • 21 Feb 2023 Status changed from not yet recruiting to withdrawn prior to enrolment as The company decided to interrupt the development of the drug in all oncological indications.
  • 02 Aug 2022 Planned initiation date changed from 1 May 2022 to 1 Oct 2022.
  • 07 Feb 2022 New trial record

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