Study on LOXO-101 for Treating Cancers with NTRK Genetic Changes
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT06390852
This clinical trial is testing how well the drug larotrectinib (LOXO-101) works in treating patients with cancers that have specific genetic changes in the NTRK gene. The study aims to see if this drug can help slow or stop the growth of cancer cells.
Patient Parameters
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Program Overview
This study is exploring the effectiveness of larotrectinib (LOXO-101) in patients whose cancer has a change in the NTRK gene. Larotrectinib is a type of medication known as a kinase inhibitor, which works by blocking a protein that tells cancer cells to grow. By doing this, it may help slow down or stop the spread of cancer.
Description
The main goal of this study is to see how many patients with advanced cancers respond to the treatment with larotrectinib. Researchers also want to find out how long patients can live without their cancer getting worse and to study other factors that might predict how well the treatment works.
Participants in the study will take larotrectinib by mouth twice a day in 28-day cycles. They will continue this treatment as long as it is effective and does not cause unacceptable side effects. During the study, participants will have regular scans, such as CT or MRI, to monitor their cancer. They will also have biopsies and blood tests to help researchers understand how the treatment is working.
After finishing the treatment, participants will have follow-up visits every three months for two years, and then every six months for one year to monitor their health.
Eligibility Criteria
Inclusion Criteria
- Must meet the eligibility criteria of the main MATCH study before joining this treatment study.
- Must have a cancer with a specific change in the NTRK1, NTRK2, or NTRK3 gene, as identified by the MATCH screening.
- Must have a recent electrocardiogram (ECG) showing no major heart rhythm problems.
- Must not be allergic to larotrectinib or similar drugs.
- Must not be taking certain medications that affect how larotrectinib works.
- Must not have previously been treated with drugs that target TRKA, TRKB, or TRKC, including larotrectinib and similar medications.
Locations
| FACILITY | ZIP | CITY | STATE |
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| ECOG-ACRIN Cancer Research Group | 19103 | Philadelphia | Pennsylvania |
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