Larotrectinib to Enhance RAI Avidity in Differentiated Thyroid Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age2-99
SponsorChildren's Hospital of Philadelphia
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Larotrectinib monotherapy
DrugPatients will receive larotrectinib monotherapy for 6 months at the FDA-approved dose.
131I therapy
RadiationPatients will receive 131I therapy after 6 months of larotrectinib.
Treatment groups
13 Participants
are divided into 1 treatment groupGroup A: Larotrectinib monotherapy with 131I therapyExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Number of patients with complete pulmonary structural response
The primary endpoint is the complete pulmonary structural response rate to larotrectinib by modified Nies et al thyroid cancer response criteria.
Time frame
18 monthsSponsors and contacts
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Children's Hospital of Philadelphia
Lead sponsor
Bayer
Collaborator
Source ClinicalTrials.gov