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Repotrectinib for Solid Tumors in Young Patients
Study Summary
This trial is testing a new drug for safety and effectiveness in treating pediatric and young adult cancer patients.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- My advanced solid tumor is NTRK fusion positive and I haven't taken TRK inhibitors.I have a condition like Crohn's disease that affects how my body absorbs drugs.You have any important irregularities in your heart's electrical activity when at rest.My blood, kidney, and liver functions are all within normal ranges.I am taking or might need strong medication that affects liver enzymes.I am under 12 for Phase 1 or between 12-25 for Phase 2.I have previously received chemotherapy.My cancer has a confirmed ALK, ROS1, or NTRK1-3 genetic change.Before joining the study, you must have a confirmed test showing that you have a measurable disease.Your heart's electrical activity, measured by a test called ECG, shows a long QT interval.My brain tumor or cancer spread to the brain is stable, and I've been on a steady or reducing dose of steroids for over 2 weeks.I have a condition or take medication that can affect my heart's rhythm.My cancer can be measured by specific medical criteria.All side effects from my previous cancer treatments, except for hair loss, are mild or gone.My cancer has specific genetic changes but doesn't qualify for other study groups.I have previously received immunotherapy.I do not have any active infections, including HIV.I do not have moderate or severe numbness, tingling, or pain in my hands or feet.I can do most activities but need help with some, regardless of my age.I have an advanced solid tumor with NTRK+ that has been treated with TRK TKI.My neuroblastoma is only in my bone marrow and can be checked with a bone marrow test.I have not had major surgery in the last 2 weeks, except for central venous access placement.You are expected to live for at least 12 weeks.
- Group 1: Repotrectinib (TPX-0005)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What are the desired outcomes of this research project?
"The goal of this trial is to assess dose-limiting toxicities (DLTs) in Phase 1. Secondary outcomes include overall survival (OS) in Phase 2, duration of response (DOR) in Phase 1 and 2, and time to response (TTR) in Phase 1 and 2."
Are there any restrictions on who is eligible to participate in this research project?
"This study is investigating a new treatment for cancer in young people. Eligible participants must be between 0 and 25 years old, have lymphoma, and meet the following criteria: A genetic alteration in ALK, ROS1, or NTRK1-3 as confirmed by testing in an accredited laboratory; no active CNS tumors or metastases; prior cytotoxic chemotherapy and immunotherapy are allowed; resolution of all acute toxic effects of prior anti-cancer therapy; measurable disease by RECIST v1.1 or RANO criteria at time of enrollment; a Lansky or Karnofsky score of at least 50."
Are we still looking for participants in this research?
"That is correct. The information available on clinicaltrials.gov clearly shows that this trial is open and recruiting patients. This specific study was posted on March 20th, 2020 with the most recent update being August 9th, 2020. They are looking for a total of 75 participants who will be spread out across 15 different locations."
How many individuals are included in this research?
"The sponsor, Turning Point Therapeutics Inc., needs to recruit 75 individuals that meet the study's inclusion criteria from different hospital sites. For example, Stollery Children's Hospital in Edmonton, Alberta and Children's Hospital Los Angeles in Los Angeles, California are both participating locations."
If a potential research subject is outside the age range of this investigation, can they still participate?
"This particular trial is only for children aged 0 to 25. Out of the 607 trials concerning patients under 18 and the 3800 trials for those over 65, this is one of the few that focuses on this age group."
Are there different research facilities participating in this trial across Canada?
"Currently, this trial is taking place in 15 different locations including Edmonton, Los Angeles and Dallas. If you are interested in enrolling, it would be most convenient to choose a clinic closest to your home to limit travel requirements."
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