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Repotrectinib for ALK, ROS1, or NTRK1-3 Alterations
This study is now recruiting.
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
Visit Criteria
This study will enroll male and female subjects up to age 25 with locally advanced or metastatic solid tumors, including primary CNS tumors and anaplastic large cell lymphoma (ALCL), with disease progression or who is non-responsive/intolerant to available therapies and for which no standard or available curative therapy exists.
The study drug Repotrectinib is administered in capsule form or liquid suspension. Study visits will also include tumor tissue submission, ECG and blood samples for the following:
- To measure blood chemistries
- To assess how the body handles the drug (pharmacokinetic studies)
- To better understand the cancer, diaries, and questionnaires.
In addition to the study visits, subjects will need to come to CHOP frequently for assessments as part of regular cancer care. This includes follow-up visits, blood draws, and scans to monitor any side effects and tumor response.
Leader
