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NCT04094610 · ClinicalTrials.gov registry record · Phase 1
A Study of Repotrectinib in Pediatric and Young Adult Subjects Harboring ALK, ROS1, OR NTRK1-3 Alterations
A Phase 1 study of Lymphoma and Metastatic Solid Tumors, sponsored by Turning Point Therapeutics.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 75
- Enrollment target
- 20
- Study locations
NCT04094610 is a Phase 1 study of Lymphoma and Metastatic Solid Tumors that is actively recruiting participants, run by Turning Point Therapeutics. The registered enrollment target is 75 participants, below the 483-participant average among 299 other Lymphoma trials with a reported enrollment target (84% lower). The trial reports 20 study locations across 15 states.
The verdict
NCT04094610, a Phase 1 study of Lymphoma and Metastatic Solid Tumors, is actively recruiting participants, sponsored by Turning Point Therapeutics.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 75 participants
- Enrollment target
- 20
- Study locations
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.
Conditions Studied
Interventions
- DRUG Oral repotrectinib (TPX-0005)
Study Locations (20)
Texas
- The University of Texas Southwestern Medical Center - Harold C Simmons Comprehensive Cancer Center - Dallas
- Baylor College of Medicine - Houston
- Local Institution - 2104 - Houston
California
- Children's Hospital Los Angeles - Los Angeles
- University of California at Los Angeles - Los Angeles
Florida
- Local Institution - 2105 - Orlando
- Local Institution - 2120 - Orlando
Pennsylvania
- Local Institution - 2114 - Hershey
- Children's Hospital of Philadelphia-Center for Childhood Cancer Research - Philadelphia
Colorado
- Children's Hospital Colorado - Anschutz Medical Campus - Aurora
Georgia
- Children's Healthcare of Atlanta - Egleston Hospital - Atlanta
Maine
- Maine Medical Center - Scarborough
Massachusetts
- Dana Farber Cancer Institute. - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2020-03-12 |
| Est. Completion | 2027-09-30 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04094610
The ClinicalTrials.gov registry entry for NCT04094610 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 75 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 483-participant average among 299 other Lymphoma trials with a reported enrollment target (84% lower). The listed sponsor is Turning Point Therapeutics, which has 7 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Lymphoma appearing as the primary indexed condition, and to 1 intervention - of which Oral repotrectinib (TPX-0005) is the first listed.
NCT04094610 reports 20 study locations spanning 15 distinct geographic areas - top geographies include Texas, California, Florida.
Frequently Asked Questions
What is clinical trial NCT04094610 about?
NCT04094610 is a clinical study titled "A Study of Repotrectinib in Pediatric and Young Adult Subjects Harboring ALK, ROS1, OR NTRK1-3 Alterations". 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 ki...
What is the current status of trial NCT04094610?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 75 participants. The study started on 2020-03-12. Estimated completion is 2027-09-30.
What conditions does trial NCT04094610 study?
This clinical trial studies the following conditions: Lymphoma, Metastatic Solid Tumors, Locally Advanced Solid Tumors, Primary CNS Tumors.
What interventions are being tested in trial NCT04094610?
The interventions under investigation include: Oral repotrectinib (TPX-0005) (DRUG).
Who is sponsoring clinical trial NCT04094610?
This trial is sponsored by Turning Point Therapeutics, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04094610 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Georgia, Maine. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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