A Study of Repotrectinib in Pediatric and Young Adult Subjects Harboring ALK, ROS1, OR NTRK1-3 Alterations
Public ClinicalTrials.gov record NCT04094610. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Phase 1 will evaluate the safety and tolerability at different dose levels of repotrectinib in pediatric and young adult subjects with advanced or metastatic malignancies harboring anaplastic lymphoma kinase (ALK), receptor tyrosine kinase encoded by the gene ROS1 (ROS1), or neurotrophic receptor kinase genes encoding TRK kinase family (NTRK1-3) alterations to estimate the Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) and select the Pediatric Recommended Phase 2 Dose (RP2D). Phase 2 will determine the anti-tumor activity of repotrectinib in pediatric and young adult subjects with advanced or metastatic malignancies harboring ROS1 or NTRK1-3 alterations.
Study identification
- NCT ID
- NCT04094610
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 75 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- Up to 25 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 12, 2020 (Actual)
- Primary completion
- Sep 30, 2026 (Estimated)
- Completion
- Sep 30, 2027 (Estimated)
- Last update posted
- Sep 25, 2026
2020 – 2027
United States locations
- U.S. sites
- 20
- U.S. states
- 15
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Children's Hospital Los Angeles | Los Angeles | California | 90027-6062 | Recruiting |
| University of California at Los Angeles | Los Angeles | California | 90095 | Recruiting |
| Children's Hospital Colorado - Anschutz Medical Campus | Aurora | Colorado | 80045 | Recruiting |
| Local Institution - 2105 | Orlando | Florida | 32806 | Completed |
| Local Institution - 2120 | Orlando | Florida | 32827 | Completed |
| Children's Healthcare of Atlanta - Egleston Hospital | Atlanta | Georgia | 30329 | Recruiting |
| Maine Medical Center | Scarborough | Maine | 04074 | Recruiting |
| Dana Farber Cancer Institute. | Boston | Massachusetts | 02215 | Recruiting |
| Washington University School of Medicine in St. Louis | St Louis | Missouri | 63110 | Recruiting |
| Local Institution - 2110 | New Brunswick | New Jersey | 08901 | Completed |
| Local Institution - 2102 | New York | New York | 10065 | Completed |
| Levine Children's Hospital- Pediatric Neuro-Oncology | Charlotte | North Carolina | 28203 | Recruiting |
| Local Institution - 2112 | Cleveland | Ohio | 44195 | Completed |
| Local Institution - 2114 | Hershey | Pennsylvania | 17033 | Completed |
| Children's Hospital of Philadelphia-Center for Childhood Cancer Research | Philadelphia | Pennsylvania | 19104 | Recruiting |
| St. Jude Children's Research Hospital | Memphis | Tennessee | 38015 | Recruiting |
| The University of Texas Southwestern Medical Center - Harold C Simmons Comprehensive Cancer Center | Dallas | Texas | 75390 | Recruiting |
| Baylor College of Medicine | Houston | Texas | 77030 | Recruiting |
| Local Institution - 2104 | Houston | Texas | 77030 | Completed |
| Children's Hospital of Richmond at VCU | Richmond | Virginia | 23219 | Withdrawn |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 48 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04094610, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 25, 2026 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04094610 live on ClinicalTrials.gov.