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Repotrectinib for Solid Tumors (TRIDENT-1 Trial)
TRIDENT-1 Trial Summary
This trial will study the side effects and best dose of repotrectinib in adults with advanced solid tumors that have a certain gene rearrangement. It will also study how repotrectinib affects the body's metabolism of midazolam.
TRIDENT-1 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTRIDENT-1 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.TRIDENT-1 Trial Design
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Who is running the clinical trial?
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- I have had chemotherapy before.I have brain metastases or leptomeningeal disease but no symptoms.I have had cancer before, but it was either skin cancer treated successfully or another type that was completely removed and didn’t need treatment in the last 2 years.My cancer is advanced and tests show specific gene changes.I am at least 18 years old, or 20 if required by local laws.I can swallow pills without breaking them.All side effects from my previous cancer treatments, except for hair loss, are mild or gone.I have brain metastases or leptomeningeal disease but no symptoms.I do not have moderate or severe numbness, tingling, or pain in my hands or feet.My advanced cancer has a specific gene change.I have previously received immunotherapy.I haven't had radiation therapy (except for bone pain relief) in the last 2 weeks.I have brain metastases or leptomeningeal involvement that causes symptoms.I have had chemotherapy before.I have had serious heart problems recently.I have severe lung scarring or disease affecting both lungs.I have not had major surgery in the last 4 weeks.I have a condition that affects how drugs are absorbed in my body.I am fully active or can carry out light work.I do not have any active infections, including HIV.I have at least one tumor that can be measured by standard criteria.I have previously received immunotherapy.I can swallow pills without breaking them.
- 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
How many venues is this clinical investigation being administered in?
"Presently, this trial is running out of 72 sites that span from Edmonton to Philadelphia and even Oxnard. To ease the burden of participation, it would be wise to select a clinic near you when registering."
What are the key targets of this investigation?
"The preeminent metric for this trial, tracked within 28 days of the initial repotrectinib dose, is to determine an ideal Recommended Phase 2 Dose (RP2D). Secondary objectives include assessing Maximum plasma concentration (CMAX) under varying food intake conditions(TPX-0005), determining Intracranial objective response rate in patients receiving repotrectinib treatment, and measuring Duration of response (DOR) associated with using this drug."
Are there still opportunities to participate in this clinical experiment?
"According to the records on clinicaltrials.gov, enrollment for this trial is still ongoing since its original posting date of February 27th 2017 and was most recently amended on November 29th 2022."
What is the recruitment size for this clinical trial?
"The sponsor, Turning Point Therapeutics Inc., must recruit 500 suitable patients in order to execute the study. These individuals will be recruited from two locations: Cross Cancer Institute PHASE 2 (Edmonton, Alberta) and Fox Chase Cancer Centre PHASE 2 (Philadelphia, Pennsylvania)."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
How responsive is this trial?
Average response time
- < 2 Days
Typically responds via
Most responsive sites:
- Memorial Healthcare System PHASE 2: < 48 hours
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