Larotrectinib for Advanced or Metastatic Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This phase II trial studies the effect of larotrectinib in treating patients with NTRK gene amplification positive solid tumors that have spread to nearby tissues or lymph nodes (locally advanced) or other places in the body (metastatic). Larotrectinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Will I have to stop taking my current medications?
The trial requires that you stop taking any strong CYP3A4 inhibitors or inducers before starting treatment. If you're on such medications, you may need to discuss alternatives with your doctor.
How is the drug Larotrectinib unique for treating advanced or metastatic cancer?
Larotrectinib is unique because it is a 'tumor-agnostic' drug, meaning it targets a specific genetic feature (NTRK gene fusions) found in various types of cancer, rather than being specific to one type of cancer. It is taken orally and is effective regardless of the patient's age or gender, offering a new option for those with these specific genetic mutations.12345
What data supports the effectiveness of the drug Larotrectinib for advanced or metastatic cancer?
Who Is on the Research Team?
David Hong, MD
Principal Investigator
M.D. Anderson Cancer Center
Are You a Good Fit for This Trial?
This trial is for adults (16+) with solid tumors that have spread and show NTRK gene amplification. Participants must have tried standard treatments, or be unlikely to benefit from them, and should not have progressed on TRK inhibitors before. They need stable organ function, measurable tumor lesions, no uncontrolled infections or diseases, and agree to use two birth control methods.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive larotrectinib sulfate orally twice daily on days 1-28. Cycles repeat every 28 days in the absence of unacceptable toxicity.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion, with follow-up at 4 weeks, and then every 3 months for 2 years.
Extension
Patients who experience disease progression and are deriving clinical benefit from larotrectinib may continue treatment per physician discretion.
What Are the Treatments Tested in This Trial?
Interventions
- Larotrectinib
Larotrectinib is already approved in United States, European Union for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator