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Clinical Trials in Spain / NCT04094610
Recruiting Phase 1/2

A Study of Repotrectinib in Pediatric and Young Adult Subjects Harboring ALK, ROS1, OR NTRK1-3 Alterations

NCT04094610 · tracked via the Priya Life Science Spain tracker
Phase
Phase 1/2
Started
2020-03-12
Last updated
2026-09-25

Condition(s) studied

Locally Advanced Solid TumorsMetastatic Solid TumorsLymphomaPrimary CNS Tumors

Investigational drug(s) / intervention(s)

Oral repotrectinib (TPX-0005) →

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

Sex
ALL
Min age
—
Max age
25 Years
Healthy volunteers
No
Key Inclusion Criteria: 1. Documented genetic ROS1 point mutation, fusion, or amplification or NTRK1-3 fusion as identified by local testing in a Clinical Laboratory Improvement Amendments (CLIA) laboratory in the US or equivalently accredited diagnostic lab outside the United States (US) is required. 2. Phase 1: Age \<12 years; Phase 2: Age 12- 25 years 3. Prior cytotoxic chemotherapy is allowed. 4. Prior immunotherapy is allowed. 5. Resolution of all acute toxic effects (excluding alopecia) of any prior anti-cancer therapy to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03 Grade less than or equal to 1. 6. All subjects must have measurable disease by RECIST v1.1 or Response Assessment in Neuro-Oncology (RANO) criteria at time of enrollment. 7. Subjects with a primary CNS tumor or CNS metastases must be neurologically stable on a stable or decreasing dose of steroids for at least 7 days prior to enrollment. 8. Subjects must have a Lansky (\< 16 years) or Karnofsky (≥ 16 years) score of at least 50. 9. Life expectancy greater than or equal to 12 weeks, in the investigator's opinion. 10. Adequate hematologic, renal and hepatic function. Phase 2 Inclusion Criteria: 1. Cohort Specific Inclusion Criteria: * Cohort 1: Subjects with NTRK fusion gene positive (NTRK+) advanced solid tumors (including primary CNS tumors), that are tropomyosin receptor kinase (TRK) TKI naïve; * Cohort 2: subjects with NTRK+ advanced solid tumors (including primary CNS tumors), that are TRK TKI pre-treated; * Cohort 3: subjects with advanced solid tumors with ROS1 gene fusions or other ROS1 aberrations (including amplifications and point mutations) with measurable disease. 2. Subjects in Cohorts 1 and 2 must have prospectively confirmed measurable disease by BICR prior to enrollment. Key Exclusion Criteria (Phase 1 and Phase 2): 1. Subjects with neuroblastoma with only bone marrow disease evaluable by bone marrow aspiration only. 2. Major surgery within 14 days (2 weeks) of start of repotrectinib treatment. Central venous access (Broviac, Mediport, etc.) placement does not meet criteria for major surgery. 3. Known active infections requiring ongoing treatment (bacterial, fungal, viral including HIV positivity). 4. Gastrointestinal disease (e.g., Crohn's disease, ulcerative colitis, or short gut syndrome) or other malabsorption syndromes that would impact drug absorption. 5. Any of the following cardiac criteria: * Mean resting corrected QT interval (ECG interval measured from the onset of the QRS complex to the end of the T wave) for heart rate (QTc) \> 480 msec obtained from three ECGs, using the screening clinic ECG machine-derived QTc value * Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG (e.g., complete left bundle branch block, third degree heart block, second degree heart block, PR interval \> 250 msec) * Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, congenital long QT syndrome, family history of long QT syndrome, or any concomitant medication known to prolong the QT interval 6. Peripheral neuropathy of CTCAE ≥grade 2. 7. Subjects being treated with or anticipating the need for treatment with strong CYP3A4 inhibitors or inducers. 8. Any potential allergies to repotrectinib and/or its excipients.

Primary outcome measure(s)

Trial sites (68)

FacilityCityRegionStatus
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 Spain

Other trials for the same condition

Official registry record

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 Spain