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Selpercatinib in Solid or CNS tumors with RET-Alterations
This study is now recruiting.
The purpose of this study is to test the safety and efficacy of the investigational drug called Selpercatinib in children whose cancers have a specific genetic change (RET-fusion or RET-mutation). Selpercatinib has been FDA-approved for adults and pediatric patients 12 years of age or older for certain types of lung and thyroid cancers. Selpercatinib is administered in capsule form, liquid suspension, or may also be administered by a feeding tube for subjects who are unable to swallow.
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 #:
19-016024
Official Title:
A Phase 1/2 Study of the Oral RET Inhibitor LOXO-292 (Selpercatinib) in Pediatric Patients with Advanced RET-Altered Solid or Primary Central Nervous System Tumors
Study Phase:
Phase I
Phase II
Eligible Age Range:
6 Months - 21 Years
Gender:
All
Visit Criteria
This study will enroll male and female patients between 6 months and 21 years of age with a locally advanced or metastatic solid or primary CNS tumor that has relapsed, progressed, or was nonresponsive to available therapies and for which no standard or available systemic curative therapy exists.
Subjects will receive a supply of Selpercatinib in capsule form or liquid suspension. Study visits will also include diaries and questionnaires, 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
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
