Health Trials

About 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.

Eligibility criteria

Qualifiers

Age ≥ 1 year

Histologic diagnosis of a differentiated thyroid cancer, s/p thyroidectomy and adequate local therapy (e.g., lymph node dissection as per standard of care) for metastatic disease in the neck in the opinion of the treating investigator

Identification of an neurotrophic tyrosine receptor kinase (NTRK) (NTRK1, NTRK2, or NTRK3) gene fusion in a CLIA/CAP accredited laboratory without known kinase domain resistance mutation

Lansky/Karnofsky performance status ≥ 50%

Disqualifiers

No prior systemic therapy for thyroid cancer, including tropomyosin receptor kinase (TRK) inhibitors. Note that prior 131I is permitted.

Females who are pregnant or breastfeeding are excluded due to the potential risks of larotrectinib and RAI to the fetus/neonate.

Concurrent therapy: Patients currently receiving a strong CYP3A4 inducer or inhibitor are not eligible. Strong inducers or inhibitors of CYP3A4 should be avoided 14 days prior to treatment to the end of the study treatment.

Trial design

Treatments tested in this trial

  • Larotrectinib monotherapy
  • 131I therapy

Treatment groups

13 Participants
are divided into 1 treatment group

Locations

5
University of California, San Francisco94115, San FranciscoCalifornia, United States
Children's Hospital of Philadelphia19104, PhiladelphiaPennsylvania, United States
St. Jude Children's Research Hospital19807, MemphisTennessee, United States
MD Anderson Cancer Center77030, HoustonTexas, United States

Sponsors and collaborators

Children's Hospital of Philadelphia

Lead sponsor

Bayer

Collaborator

Source ClinicalTrials.gov