GO42286 iMATRIX (Alectinib)

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

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

Recruiting

Summary

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

Alectinib is a selective ALK- and RET-kinase inhibitor. Inhibiting these proteins inhibits tumor growth and leads to death of tumor cells. 
Participants will receive twice-daily alectinib orally as capsules on Days 1-28 of each 28-day cycle.

Main inclusion criteria

  • Pediatric and adolescents patients < 17 years
  • Diagnosis of relapsed or refractory ALK Fusion-positive CNS or solid tumor
  • Measurable and evaluable disease as defined by RECIST/RANO criteria
  • Karnofsky oder Lansky > 50

Sponsor

Hoffmann-La Roche

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