RXDX-101-03 – 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 (Igny

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.

Principal Investigator:
Elyssa Rubin, MD

Research Coordinator:
Dorian Chan, RN
(714) 509-8646

Visit clinicaltrials.gov for more information about this trial.

  • Clinical Trial Info
  • IRB Number: 170104
  • Sponsor: Ignyta, Inc.
  • Protocol Number: RXDX 101
  • NCT Number: NCT02650401
  • Research Type: Adolescents and Young Adults, Brain Tumor/Central Nervous System/Neuro-Oncology, Recurrent/Refractory Cancer, Solid Tumors
  • Phase: I
  • Status: Active

Key Inclusion Criteria:

  • Age: 2 Years to 22 Years
  • Ability to swallow capsules unless enrolled in Part E
  • Body surface area (BSA): Subjects must have a body surface area ≥ 0.45 m2 at the time of the study enrollment, unless enrolled in Part E
  • Adequate organ and neurologic function

Key Exclusion Criteria:

  • Known congenital long QT syndrome
  • Receiving Enzyme Inducing Antiepileptic Drugs (EIAEDs) within 14 days of first dose.
  • Incomplete recovery from acute effects of any surgery prior to treatment.
  • Active gastrointestinal disease or other malabsorption syndromes that would impact drug absorption.

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UC Irvine

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