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A Phase 1 / 1b, Open-Label, Dose-Escalation and Expansion Study of Entrectinib (RXDX 101) in Children and Adolescents With Recurrent or Refractory Solid Tumors and Primary CNS Tumors, With or Without TRK, ROS1, or ALK Fusions

Status
Active
Cancer Type
Neuroblastoma
Trial Phase
Phase I
Eligibility
2 - 22 Years, Male and Female
Study Type
Treatment
NCD ID
NCT02650401
Protocol IDs
RXDX-101-03 (primary)
NCI-2016-00924
Study Sponsor
Ignyta Inc

Summary

This is a 5-part, open-label, Phase 1 / 1b multicenter, dose escalation study in pediatric patients with relapsed refractory solid tumors; 2) primary CNS tumors; 3) neuroblastoma; 4) non-neuroblastoma, extracranial solid tumors with NTRK1 / 2 / 3, ROS1 or ALK gene rearrangements; and 5) patients who are otherwise eligible but unable to swallow capsules. The study is designed to explore the safety, maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D), pharmacokinetics, and antitumor activity of entrectinib.
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