A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Alectinib in Pediatric Participants With ALK Fusion-Positive Solid or CNS Tumours

Official Title

A Phase I/II, Open-Label, Multicentre, Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Alectinib in Pediatric Participants With ALK Fusion-Positive Solid or CNS Tumours for Whom Prior Treatment Has Proven to be Ineffective or for Whom There is No Satisfactory Treatment Available

Summary:

This study will evaluate the safety, pharmacokinetics, and efficacy of alectinib in children and adolescents with ALK fusion-positive solid or CNS tumours for whom prior treatment has proven to be ineffective or for whom there is no satisfactory standard treatment available.

Trial Description

Primary Outcome:

  • Incidence of Participants with Dose-Limited Toxicities (DLTs)
  • Percentage of Participants with Adverse Events
  • Plasma Concentration of Alectinib
  • Plasma Concentration of Alectinib Metabolite (M4)
  • Confirmed Objective Response Rate (ORR): Defined as the Proportion of Participants with Complete Response (CR) or Partial Response (PR) on two Consecutive Occasions >/= 4 Weeks Apart, as Determined by Blinded Independent Central Review (BICR)
Secondary Outcome:
  • Confirmed ORR as Determined by the Investigator
  • Duration of Response (DOR) as Determined by BICR and the Investigator
  • Time to Response (TTR) as Determined by BICR and the Investigator
  • Clinical Benefit Rate (CBR) as Determined by BICR and the Investigator
  • Progression-Free Survival (PFS) as Determined by BICR and the Investigator
  • Overall Survival (OS)

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society