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, NTRK1-3 Alterations

Who is this study for? Patients with Solid Tumors
What treatments are being studied? Oral Repotrectinib (TPX-0005)
Status: Recruiting
Location: See all (68) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: All
Maximum Age: 25
Healthy Volunteers: f
View:

• 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.

• Phase 1: Age \<12 years; Phase 2: Age 12- 25 years

• Prior cytotoxic chemotherapy is allowed.

• Prior immunotherapy is allowed.

• 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.

• All subjects must have measurable disease by RECIST v1.1 or Response Assessment in Neuro-Oncology (RANO) criteria at time of enrollment.

• 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.

• Subjects must have a Lansky (\< 16 years) or Karnofsky (≥ 16 years) score of at least 50.

• Life expectancy greater than or equal to 12 weeks, in the investigator's opinion.

⁃ Adequate hematologic, renal and hepatic function.

∙ Phase 2 Inclusion Criteria:

• 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.

• Subjects in Cohorts 1 and 2 must have prospectively confirmed measurable disease by BICR prior to enrollment.

Locations
United States
California
Children's Hospital Los Angeles
RECRUITING
Los Angeles
University of California at Los Angeles
RECRUITING
Los Angeles
Colorado
Children's Hospital Colorado - Anschutz Medical Campus
RECRUITING
Aurora
Florida
Local Institution - 2105
COMPLETED
Orlando
Local Institution - 2120
COMPLETED
Orlando
Georgia
Children's Healthcare of Atlanta - Egleston Hospital
RECRUITING
Atlanta
Massachusetts
Dana Farber Cancer Institute.
RECRUITING
Boston
Maine
Maine Medical Center
RECRUITING
Scarborough
Missouri
Washington University School of Medicine in St. Louis
RECRUITING
St Louis
North Carolina
Levine Children's Hospital- Pediatric Neuro-Oncology
RECRUITING
Charlotte
New Jersey
Local Institution - 2110
COMPLETED
New Brunswick
New York
Local Institution - 2102
COMPLETED
New York
Ohio
Local Institution - 2112
COMPLETED
Cleveland
Pennsylvania
Local Institution - 2114
COMPLETED
Hershey
Children's Hospital of Philadelphia-Center for Childhood Cancer Research
RECRUITING
Philadelphia
Tennessee
St. Jude Children's Research Hospital
RECRUITING
Memphis
Texas
The University of Texas Southwestern Medical Center - Harold C Simmons Comprehensive Cancer Center
RECRUITING
Dallas
Baylor College of Medicine
RECRUITING
Houston
Local Institution - 2104
COMPLETED
Houston
Virginia
Children's Hospital of Richmond at VCU
WITHDRAWN
Richmond
Other Locations
Australia
Perth Childrens Hospital
RECRUITING
Nedlands
Local Institution - 6104
RECRUITING
Randwick
Children's Health Queensland Hospital and Health Service
RECRUITING
South Brisbane
Local Institution - 6103
COMPLETED
Westmead
Canada
University Of Calgary
RECRUITING
Calgary
Stollery Children'S Hospital
RECRUITING
Edmonton
St Justine Hospital
RECRUITING
Montreal
Children'S Hospital Of Eastern Ontario
RECRUITING
Ottawa
Denmark
Rigshospitalet - Glostrup
RECRUITING
Copenhagen
France
Centre Hospitalier Universitaire D'Angers
RECRUITING
Angers
Centre Hospitalier Universitaire de Bordeaux - Groupe Hospitalier Pellegrin
RECRUITING
Bordeaux
Institut d Hematologie et d Oncologie Pediatriques
RECRUITING
Lyon
Local Institution - 6111
NOT_YET_RECRUITING
Lyon
Hôpitaux Universitaires de Marseille Timone
RECRUITING
Marseille
Local Institution - 6110
NOT_YET_RECRUITING
Marseille
Local Institution - 6112
NOT_YET_RECRUITING
Nantes
Local Institution - 6109
NOT_YET_RECRUITING
Paris
Institut Gustave-Roussy
RECRUITING
Villejuif
Local Institution - 6108
NOT_YET_RECRUITING
Villejuif
Italy
Fondazione IRCCS - Istituto Nazionale dei Tumori
RECRUITING
Milan
Local Institution - 6113
WITHDRAWN
Padua
Local Institution - 4302
NOT_YET_RECRUITING
Rome
Local Institution - 6114
WITHDRAWN
Torino
Republic of Korea
Asan Medical Center
RECRUITING
Seoul
Local Institution - 6303
COMPLETED
Seoul
Local Institution - 6304
COMPLETED
Seoul
Seoul National University Hospital
RECRUITING
Seoul
Singapore
KK Women's and Children's Hospital
RECRUITING
Singapore
National University Hospital
RECRUITING
Singapore
Spain
Hospital Universitari Vall d'Hebron
RECRUITING
Barcelona
Local Institution - 6105
NOT_YET_RECRUITING
Barcelona
Hospital Sant Joan De Deu
RECRUITING
Esplugues De Llobregat
Clinica Universidad de Navarra
RECRUITING
Madrid
HM Sanchinarro University Hospital
RECRUITING
Madrid
Hospital Infantil Universitario Nino Jesus
RECRUITING
Madrid
Local Institution - 6106
NOT_YET_RECRUITING
Madrid
Clínica Universidad de navarra
RECRUITING
Pamplona
Hospital Universitario Virgen del Rocio
RECRUITING
Seville
Hospital Universitario Y Politecnico La Fe
RECRUITING
Valencia
Local Institution - 6107
NOT_YET_RECRUITING
Valencia
Taiwan
National Taiwan University Hospital
RECRUITING
Taipei
Taipei Medical University Hospital
RECRUITING
Taipei
United Kingdom
Local Institution - 4403
COMPLETED
Birmingham
University Hospital of Wales
RECRUITING
Cardiff
Royal Hosp. for Children
RECRUITING
Glasgow
Alder Hey Children's NHS Foundation Trust
RECRUITING
Liverpool
Great Ormond Street Hospital For Children NHS Foundation Trust
RECRUITING
London
The Royal Marsden NHS Foundation Trust
RECRUITING
London
Contact Information
Primary
BMS Study Connect Contact Center www.BMSStudyConnect.com
Clinical.Trials@bms.com
855-907-3286
Backup
First line of the email MUST contain the NCT# and Site #.
Time Frame
Start Date: 2020-03-12
Estimated Completion Date: 2027-09-30
Participants
Target number of participants: 75
Treatments
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
Sponsors
Leads: Turning Point Therapeutics, Inc.

This content was sourced from clinicaltrials.gov

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