Larotrectinib for Thyroid Cancer

Phase 2

Recruiting

Led By Theodore Laetsch, MD

Research Sponsored by Theodore Laetsch

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 18 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is looking at a new treatment option for patients with advanced papillary thyroid cancer after surgery. The current treatment, radioactive iodine therapy, is not always effective and has potential risks such as lung

Who is the study for?

This trial is for people of any age over 1 year with a specific type of thyroid cancer, who've had surgery and possibly other treatments for neck metastases. They must have certain lung nodules seen on CT scans and an NTRK gene fusion without resistance mutations. Good performance status and organ function are required, including specific blood cell counts and creatinine levels.

What is being tested?

The study tests Larotrectinib's ability to improve the effectiveness of radioactive iodine (RAI) therapy in treating advanced differentiated thyroid cancer after surgery. It aims to see if this drug can help those who don't fully respond to RAI, which has risks like pulmonary fibrosis and secondary cancers.

What are the potential side effects?

While not explicitly listed here, common side effects from Larotrectinib may include fatigue, dizziness, nausea; RAI therapy could lead to dry mouth/throat issues or more serious concerns such as lung scarring or second cancers.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of patients with complete pulmonary structural response

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Larotrectinib monotherapy with 131I therapyExperimental Treatment2 Interventions

Patients will receive larotrectinib monotherapy for 6 months at the FDA-approved dose. Patients will receive 131I therapy after 6 months of larotrectinib. Larotrectinib will be continued for 5 days after RAI therapy and then patients will enter a wait and see period off treatment. Patients who experience disease progression at any point while on larotrectinib will proceed to 131I therapy and discontinue larotrectinib.

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