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A Phase 1/2 Study of Crizotinib, an Oral Small Molecule Inhibitor of Anaplastic Lymphoma Kinase (ALK) and C-Met, in Children With Relapsed/Refractory Solid Tumors and Anaplastic Large Cell Lymphoma

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Trial Profile

A Phase 1/2 Study of Crizotinib, an Oral Small Molecule Inhibitor of Anaplastic Lymphoma Kinase (ALK) and C-Met, in Children With Relapsed/Refractory Solid Tumors and Anaplastic Large Cell Lymphoma

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 09 Nov 2021

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At a glance

  • Drugs Crizotinib (Primary)
  • Indications Anaplastic large cell lymphoma; Neuroblastoma; Solid tumours
  • Focus Adverse reactions; Pharmacokinetics; Registrational
  • Sponsors Pfizer

Most Recent Events

  • 10 Feb 2021 Results (n=20, patients enrolled between March 2012 and July 2015) of patients with relapsed/refractory ALK-positive neuroblastoma published in the Clinical Cancer Research
  • 14 Jan 2021 According to a Pfizer media release, the U.S. FDA approved the supplemental New Drug Application (sNDA) for XALKORI (crizotinib) for the treatment of pediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL) that is anaplastic lymphoma kinase (ALK)-positive.The FDA approval is based on results from Study ADVL0912 (NCT00939770).
  • 23 Sep 2020 According to the Pfizer media release, the FDA submission is in addition to the European Medicines Agency's agreement on a Pediatric Investigational Plan (PIP) for XALKORI. This decision represents a step forward for potential regulatory submission for XALKORI in pediatric patients with relapsed or refractory ALK-positive ALCL in the European Union.

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