A Study of Repotrectinib in Pediatric and Young Adult Subjects Harboring ALK, ROS1, OR NTRK1-3 Alterations
Condition(s) studied
Investigational drug(s) / intervention(s)
Oral repotrectinib (TPX-0005): Oral repotrectinib (TPX-0005)
Study summary
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.
Eligibility
Primary outcome measure(s)
- Dose limiting toxicities (DLTs) (Phase 1) — Within 28 days of the first repotrectinib dose
Define the dose limiting toxicities (DLTs) (Phase 1) - Pediatric Recommended Phase 2 Dose (RP2D) (Phase 1) — Within 28 days of the last patient dosed in escalation
To determine the pediatric RP2D (Phase 1) - Overall Response Rate (ORR) (Phase 2) — Two to three years after first dose of repotrectinib
To determine the confirmed ORR of repotrectinib (TPX-0005) as assessed by Blinded Independent Central Review (Phase 2)
Trial sites (68)
| Facility | City | Region | Status |
|---|---|---|---|
| Children's Hospital Los Angeles | Los Angeles | California | Recruiting |
| University of California at Los Angeles | Los Angeles | California | Recruiting |
| Children's Hospital Colorado - Anschutz Medical Campus | Aurora | Colorado | Recruiting |
| Local Institution - 2105 | Orlando | Florida | Completed |
| Local Institution - 2120 | Orlando | Florida | Completed |
| Children's Healthcare of Atlanta - Egleston Hospital | Atlanta | Georgia | Recruiting |
| Maine Medical Center | Scarborough | Maine | Recruiting |
| Dana Farber Cancer Institute. | Boston | Massachusetts | Recruiting |
| Washington University School of Medicine in St. Louis | St Louis | Missouri | Recruiting |
| Local Institution - 2110 | New Brunswick | New Jersey | Completed |
| Local Institution - 2102 | New York | New York | Completed |
| Levine Children's Hospital- Pediatric Neuro-Oncology | Charlotte | North Carolina | Recruiting |
| Local Institution - 2112 | Cleveland | Ohio | Completed |
| Local Institution - 2114 | Hershey | Pennsylvania | Completed |
| Children's Hospital of Philadelphia-Center for Childhood Cancer Research | Philadelphia | Pennsylvania | Recruiting |
| St. Jude Children's Research Hospital | Memphis | Tennessee | Recruiting |
| The University of Texas Southwestern Medical Center - Harold C Simmons Comprehensive Cancer Center | Dallas | Texas | Recruiting |
| Baylor College of Medicine | Houston | Texas | Recruiting |
| Local Institution - 2104 | Houston | Texas | Completed |
| Children's Hospital of Richmond at VCU | Richmond | Virginia | Withdrawn |
| Local Institution - 6104 | Randwick | New South Wales | Recruiting |
| Local Institution - 6103 | Westmead | New South Wales | Completed |
| Children's Health Queensland Hospital and Health Service | South Brisbane | Queensland | Recruiting |
| Perth Childrens Hospital | Nedlands | Western Australia | Recruiting |
| University Of Calgary | Calgary | Alberta | Recruiting |
| Stollery Children'S Hospital | Edmonton | Alberta | Recruiting |
| Children'S Hospital Of Eastern Ontario | Ottawa | Ontario | Recruiting |
| St Justine Hospital | Montreal | Quebec | Recruiting |
| Rigshospitalet - Glostrup | Copenhagen | Denmark | Recruiting |
| Local Institution - 6111 | Lyon | Rhone | Not Yet Recruiting |
| Centre Hospitalier Universitaire D'Angers | Angers | France | Recruiting |
| Centre Hospitalier Universitaire de Bordeaux - Groupe Hospitalier Pellegrin | Bordeaux | France | Recruiting |
| Institut d Hematologie et d Oncologie Pediatriques | Lyon | France | Recruiting |
| Hôpitaux Universitaires de Marseille Timone | Marseille | France | Recruiting |
| Local Institution - 6110 | Marseille | France | Not Yet Recruiting |
| Local Institution - 6112 | Nantes | France | Not Yet Recruiting |
| Local Institution - 6109 | Paris | France | Not Yet Recruiting |
| Institut Gustave-Roussy | Villejuif | France | Recruiting |
| Local Institution - 6108 | Villejuif | France | Not Yet Recruiting |
| Fondazione IRCCS - Istituto Nazionale dei Tumori | Milan | Italy | Recruiting |
+ 28 more sites — see the full list on the official registry below.
More Turning Point Therapeutics, Inc. trials in the UK
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04094610 on ClinicalTrials.gov ↗ ← All trials in the UK