Repotrectinib for ALK, ROS1, or NTRK1-3 Alterations

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The purpose of this study is to test the safety and efficacy of the investigational drug called repotrectinib in children whose cancers have specific genetic changes (in the ALK, ROS1, or NTRK1-3 genes). This is the first study using this drug in children under 12 years of age. Repotrectinib is administered in capsule form or liquid suspension.

Who Do I Contact?

If you are interested in participating in the study or want to learn more please contact our study team at CancerTrials [at] chop.edu or 267-425-5544.

Eligibility & Criteria

IRB #:
20-018288
Official Title:
A Phase 1/2, Open-label, Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity Study of Repotrectinib in Pediatric and Young Adult Subjects with Advanced or Metastatic Malignancies Harboring ALK, ROS1, or NTRK1-3 Alterations (CARE)
Study Phase:
Phase I
Phase II
Eligible Age Range:
0 - 25 Years
Gender:
All
Study Categories:

Visit Criteria

As a participant in the research, you will:

  • Be given repotrectinib to take in the clinic and at home
  • Complete frequent clinic visits at CHOP
  • Have frequent blood tests, including research blood tests to measure repotrectinib levels (pharmacokinetic studies), hormone levels (in males only), and tests to measure genetic material in your blood
  • Have periodic EKGs and echocardiograms
  • Imaging performed as part of clinical care will be continued
  • Be asked to complete medication diaries
  • Be asked if we can submit previously obtained samples of your tumor to the sponsor; this will not require new biopsy
Leader
Theodore W. Laetsch

Theodore Laetsch, MD