RECRUITING

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

Talk to us

Conditions

Locally Advanced Solid TumorsMetastatic Solid TumorsLymphomaPrimary CNS TumorsALKROS1NTRK1-3Primary CNS tumoranaplastic large cell lymphomametastatic solid tumoradvanced solid tumorsarcomainfantile fibrosarcomaglioblastomasoft tissue schwannomasolitary fibrous tumorgliomainflammatory myofibroblastic tumorpediatric

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2020-03-12
Study Completion:2027-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04094610

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified to 25 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. 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. 2. Phase 1: Age \<12 years; Phase 2: Age 12- 25 years
  3. 3. Prior cytotoxic chemotherapy is allowed.
  4. 4. Prior immunotherapy is allowed.
  5. 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. 6. All subjects must have measurable disease by RECIST v1.1 or Response Assessment in Neuro-Oncology (RANO) criteria at time of enrollment.
  7. 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. 8. Subjects must have a Lansky (\< 16 years) or Karnofsky (≥ 16 years) score of at least 50.
  9. 9. Life expectancy greater than or equal to 12 weeks, in the investigator's opinion.
  10. 10. Adequate hematologic, renal and hepatic function.
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

BMS Study Connect Contact Center www.BMSStudyConnect.com
CONTACT
855-907-3286
Clinical.Trials@bms.com
First line of the email MUST contain the NCT# and Site #.
CONTACT

Principal Investigator

Bristol-Myers Squibb
STUDY_DIRECTOR
Bristol-Myers Squibb

Study Locations (Sites)

Children's Hospital Los Angeles
Los Angeles, California, 90027-6062
United States
University of California at Los Angeles
Los Angeles, California, 90095
United States
Children's Hospital Colorado - Anschutz Medical Campus
Aurora, Colorado, 80045
United States
Arnold Palmer Hospital For Children
Orlando, Florida, 32806
United States
Local Institution - 2120
Orlando, Florida, 32827
United States
Local Institution - 2119
Atlanta, Georgia, 30329
United States
Maine Medical Center
Scarborough, Maine, 04074
United States
Dana Farber Cancer Institute.
Boston, Massachusetts, 02215
United States
Washington University School of Medicine in St. Louis
Saint Louis, Missouri, 63110
United States
Local Institution - 2110
New Brunswick, New Jersey, 08901
United States
Memorial Sloan-Kettering Cancer Center.
New York, New York, 10065
United States
Local Institution - 2121
Charlotte, North Carolina, 28203
United States
Local Institution - 2112
Cleveland, Ohio, 44195
United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
United States
Children'S Hospital Of Philadelphia
Philadelphia, Pennsylvania, 19104
United States
St. Jude Children's Research Hospital
Memphis, Tennessee, 38015
United States
The University of Texas Southwestern Medical Center - Harold C Simmons Comprehensive Cancer Center
Dallas, Texas, 75390
United States
Local Institution - 2118
Houston, Texas, 77030
United States
The University of Texas MD Anderson Cancer Center.
Houston, Texas, 77030
United States
Children's Hospital of Richmond at VCU
Richmond, Virginia, 23219
United States

Collaborators and Investigators

Sponsor: Turning Point Therapeutics, Inc.

  • Bristol-Myers Squibb, STUDY_DIRECTOR, Bristol-Myers Squibb

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-03-12
Study Completion Date2027-09-30

Study Record Updates

Study Start Date2020-03-12
Study Completion Date2027-09-30

Terms related to this study

Keywords Provided by Researchers

  • ALK
  • ROS1
  • NTRK1-3
  • Primary CNS tumor
  • anaplastic large cell lymphoma
  • metastatic solid tumor
  • advanced solid tumor
  • sarcoma
  • infantile fibrosarcoma
  • glioblastoma
  • soft tissue schwannoma
  • solitary fibrous tumor
  • glioma
  • inflammatory myofibroblastic tumor
  • pediatric

Additional Relevant MeSH Terms

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