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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Turning Point Therapeutics, Inc.
Study ID
NCT04094610
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Locally Advanced Solid Tumors
  • Lymphoma
  • Metastatic Solid Tumors
  • Primary CNS Tumors

Eligibility Criteria

Sex
ALL
Age
N/A - 25 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Mar 12, 2020
Status verified
Nov 2025
Primary completion
Sep 30, 2026
Completion
Sep 30, 2027

Study Design

Enrollment
75 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Repotrectinib (TPX-0005)
    Phase 1 Oral repotrectinib (TPX-0005): Safety and tolerability at different dose levels Phase 2 Oral repotrectinib (TPX-0005): 3 cohorts Cohort 1: TKI-naive NTRK fusion Cohort 2: Prior TKI NTRK fusion Cohort 3: ROS1 gene fusions or other ROS1 aberrations

Primary Outcome Measure

Dose limiting toxicities (DLTs) (Phase 1) [ Time Frame: Within 28 days of the first repotrectinib dose ]

Central Contacts

  • BMS Study Connect Contact Center www.BMSStudyConnect.com
    855-907-3286
    [email protected]
  • First line of the email MUST contain the NCT# and Site #.

Locations (20)

FacilityCityStateZIPSite coordinators
Children's Hospital Los AngelesLos AngelesCalifornia90027-6062
Leo Mascarenhas, Site 2111
323-361-5418
University of California at Los AngelesLos AngelesCalifornia90095
Noah Federman, Site 2109
310-206-7625
Children's Hospital Colorado - Anschutz Medical CampusAuroraColorado80045
Margaret Macy, Site 2108
720-777-8856
Local Institution - 2105OrlandoFlorida32806-
Local Institution - 2120OrlandoFlorida32827-
Children's Healthcare of Atlanta - Egleston HospitalAtlantaGeorgia30329
Tobey Macdonald, Site 2119
000-000-0000
Maine Medical CenterScarboroughMaine04074
Stanley Chaleff, Site 2115
207-396-7565
Dana Farber Cancer Institute.BostonMassachusetts02215
Steven Dubois, Site 2106
415-476-3831
Washington University School of Medicine in St. LouisSt LouisMissouri63110
Andrew Cluster, Site 2113
443-745-4180
Local Institution - 2110New BrunswickNew Jersey08901-
Local Institution - 2102New YorkNew York10065-
Levine Children's Hospital- Pediatric Neuro-OncologyCharlotteNorth Carolina28203
Chad Jacobsen, Site 2121
000-000-0000
Local Institution - 2112ClevelandOhio44195-
Local Institution - 2114HersheyPennsylvania17033-
Children's Hospital of Philadelphia-Center for Childhood Cancer ResearchPhiladelphiaPennsylvania19104
Theodore Laetsch, Site 2117
267-425-5544
St. Jude Children's Research HospitalMemphisTennessee38015
Alberto Pappo, Site 2103
901-595-3300
The University of Texas Southwestern Medical Center - Harold C Simmons Comprehensive Cancer CenterDallasTexas75390
Tanya Carens Watt, Site 2101
Baylor College of MedicineHoustonTexas77030
Matthew McEvoy, Site 2118
Local Institution - 2104HoustonTexas77030-
Children's Hospital of Richmond at VCURichmondVirginia23219-

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By research site
Children's Hospital Los Angeles· Los Angeles, CAUniversity of California at Los Angeles· Los Angeles, CAChildren's Hospital Colorado - Anschutz Medical Campus· Aurora, COLocal Institution - 2105· Orlando, FLLocal Institution - 2120· Orlando, FLChildren's Healthcare of Atlanta - Egleston Hospital· Atlanta, GA

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