Larotrectinib for Thyroid Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
Papillary thyroid cancer (PTC) is the most common form of differentiated thyroid cancer (DTC). The traditional first line treatment for patients with advanced DTC after surgical resection is radioactive iodine (RAI) therapy. However, less than a quarter of patients with lung metastases will achieve a complete response to RAI therapy, and this therapy carries the risk of pulmonary fibrosis and an increasingly recognized risk of secondary malignancies.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop all current medications, but you cannot take strong CYP3A4 inducers or inhibitors starting 14 days before and during the study.
Is larotrectinib safe for treating thyroid cancer?
What makes the drug larotrectinib unique for treating thyroid cancer?
Larotrectinib is unique because it is a highly selective TRK inhibitor that can effectively treat thyroid cancer with specific genetic mutations (NTRK3 fusion-positive), especially when the cancer does not respond to standard radioactive iodine therapy. It has shown promising results, including complete responses in some patients, offering a new option for those with limited treatment choices.24678
Who Is on the Research Team?
Theodore W. Laetsch
Principal Investigator
Children's Hospital of Philadelphia
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Larotrectinib Treatment
Participants receive larotrectinib monotherapy for 6 months at the FDA-approved dose
131I Therapy
Participants receive 131I therapy after 6 months of larotrectinib. Larotrectinib is continued for 5 days after RAI therapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- 131I therapy
- Larotrectinib
131I therapy is already approved in United States, European Union, Canada for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Theodore Laetsch
Lead Sponsor
Children's Hospital of Philadelphia
Lead Sponsor
Bayer
Industry Sponsor
Bill Anderson
Bayer
Chief Executive Officer since 2023
BSc in Chemical Engineering from the University of Texas, MSc in Chemical Engineering and Management from MIT
Michael Devoy
Bayer
Chief Medical Officer since 2014
MD, PhD