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Information is also accessible through the patient and families tab. Family friendly summaries are created and reviewed by our advocacy partners. The information is updated to the best of our knowledge but might not reflect the latest information. Note that most studies are only available at a limited number of sites, please click on ‘further information’ for details. Studies, particularly early phase trials, may also temporarily close to enrolment or not have slots available for all treatment groups. In all cases, study teams at individual C17 centres will have the most up-to-date information.

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Title
Status

 

TPX-0005-07 - 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

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TPX-0005-07 - 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

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DiagnosisNon-Hodgkin Lymphoma, solid tumours, CNS tumours with eligible genetic changesStudy StatusOpen
PhaseI/II
AgeChild, Adult - (Up to 25 Years)RandomisationNO
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationRepotrectinib: Oral
Last Posted Update2024-03-15
ClinicalTrials.gov #NCT04094610
International Sponsor
Turning Point Therapeutics, Inc.
Principal Investigators for Canadian Sites
Stollery Children's Hospital - Dr. Sunil Desai
Alberta Children's Hospital - Dr. Victor Lewis
Centres
Medical contact
Dr. Sarah McKillop
Dr. Sunil Desai

 

 

Social worker/patient navigator contact
Danielle Sikora
 Michelle Woytiuk 
Jaime Hobbs
Clinical research contact
Amanda Perreault
Medical contact
Dr. Victor Lewis

 

Social worker/patient navigator contact
Wendy Pelletier
Clinical research contact
Debra Rich

 

 

Study Description

The purpose of this study is to test the safety of a cancer drug called repotrectinib in children. The cancer must have a change in a particular gene (ALK, ROS1 or NTRK). Those gene changes lead to abnormal proteins which may cause cancer cells to grow. Repotrectinib blocks the actions of these genes in cancer cells and can therefore be used to treat cancer.

The first study part (Phase 1) is done to determine what dose level of repotrectinib is safe for children, how the drug is absorbed. This phase is now closed.

The main purpose of the second study part (Phase 2) is to investigate how well and how long different cancer types respond to the treatment with repotrectinib.

 

This study is divided into 2 stages/phases.

The first stage or phase evaluates the safety and tolerability of the drug (repotrectinib) in patients with advanced cancers. This allows researchers to determine the Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) which can then be used to select the recommended dose for patients. This phase is now closed.

The second stage or phase will determine the effectiveness of the drug (repotrectinib) in treating advanced cancers.

Inclusion Criteria

For the first phase:

  • Age <12 years
  • Patients with advanced or metastatic cancer, including brain tumours or certain types of lymphoma
  • The tumour must have a change in one of the following genes: ALK, ROS1 or NTRK
  • Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team.

For the second phase:

  • Age 12 to less than 25 years
  • Patients with advanced or metastatic cancer, including brain tumours or certain types of lymphoma
  • The tumour must have a change in one of the following genes: ALK, ROS1 or NTRK
  • Some patients may be eligible even if they have already received another drug blocking NTRK in the past
  • Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team.