Larotrectinib for Treating Solid Tumors with NTRK Gene Amplification

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04879121

Provider View

This study is testing the effects of larotrectinib on patients with solid tumors that have a specific gene change called NTRK amplification. The trial aims to see if larotrectinib can stop tumor growth in these cases.

Patient Parameters

Program Overview

This phase II clinical trial is exploring how well larotrectinib works in treating patients with solid tumors that have a specific genetic change known as NTRK amplification. These tumors may have spread to nearby tissues or lymph nodes (locally advanced) or to other parts of the body (metastatic). Larotrectinib is thought to work by blocking certain enzymes that tumor cells need to grow.

Description

The main goal of this study is to find out how many patients with advanced solid tumors and NTRK amplification respond to treatment with larotrectinib. Researchers will measure the response rate by looking at how many patients have a complete or partial reduction in tumor size. They will also assess how long these responses last and whether the tumors shrink at all.

Other goals include evaluating how long patients live without the disease getting worse and the overall survival rate. The study will also look at the safety and side effects of larotrectinib.

Patients will take larotrectinib by mouth twice a day in 28-day cycles. If the treatment is helping and not causing unacceptable side effects, patients may continue taking it even if the disease progresses, as decided by their doctor.

After finishing the treatment, patients will have follow-up visits at 4 weeks, and then every 3 months for 2 years.

Eligibility Criteria

Inclusion Criteria

  • Be at least 16 years old.
  • Have a locally advanced or metastatic cancer with NTRK gene amplification, confirmed by specific lab tests.
  • Have tried standard treatments for their cancer type and stage, or be unlikely to benefit from them.
  • Have at least one measurable tumor.
  • For brain tumors, have received prior treatment and have a stable condition.
  • Have a performance status score of 3 or less, indicating the ability to carry out daily activities.
  • Provide a tumor tissue sample, if available.
  • Have liver and kidney function within specified limits.
  • Be able to attend outpatient treatments and follow-up visits.
  • Agree to use effective birth control during and for 3 months after treatment.

Exclusion Criteria

  • Have taken another investigational or cancer treatment recently.
  • Have previously progressed on TRK-targeting drugs, unless stopped early due to side effects.
  • Have unstable or symptomatic brain metastases requiring steroids.
  • Have another uncontrolled cancer that could interfere with the study.
  • Have active infections or unstable heart conditions.
  • Have had a heart attack or stroke within the last 3 months.
  • Cannot stop taking certain medications that affect drug metabolism.
  • Are pregnant or breastfeeding.

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