Selpercatinib Pre-RAI in Patients With RET Fusion Thyroid Cancer (RAISE)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age2-25
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 2-25 years, inclusive
Histologic diagnosis of a differentiated thyroid cancer, status post 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 activating RET gene alteration (fusion or mutation). The RET alteration result should be generated from a laboratory with specific certifications (depending on country requirement) that clearly denotes the presence of a RET alteration without known kinase domain resistance mutation
Lansky/Karnofsky performance status >50%
Disqualifiers
No prior systemic therapy for thyroid cancer, including RET inhibitors. Note: prior 131I is allowed.
Females who are pregnant or breastfeeding are excluded due to the potential risks of selpercatinib and radioactive iodine 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.
Patients with clinically significant active cardiovascular disease, Torsades de pointes, or history of myocardial infarction within 6 months prior to planned start of study treatment or prolongation of the QT interval corrected for heart rate using Fridericia's formula (QTcF) >470 msec.
Trial design
Design model
Single group
Treatments tested in this trial
Selpercatinib Monotherapy
DrugPatients will receive selpercatinib monotherapy for 6 months at the FDA-approved dose.
131I Therapy
RadiationPatients will receive 131I therapy after 6 months of selpercatinib.
Treatment groups
13 Participants
are divided into 1 treatment groupGroup A: Experimental: Selpercatinib Monotherapy with 131I TherapyExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Number of patients with complete overall, pulmonary, structural, and biochemical response.
Determine the overall, pulmonary, structural, and biochemical response rate to selpercatinib in patients with RET fusion differentiated thyroid cancer treated with 6 months of selpercatinib prior to 131I therapy
Time frame
18 months2
Number of patients who survive without progression of disease after 5 years following protocol treatment.
Determine the progression free survival to the combination of selpercatinib followed 6 months later 131I therapy from the initiation of selpercatinib therapy
Time frame
5 years3
Proportion of all patients enrolled who show increased radioactive iodine avidity at 6 months following selpercatinib monotherapy.
Determine the proportion of patients for whom oncogene-specific, targeted therapy increases tumor RAI-avidity.
Time frame
6 months4
The incidence of adverse events and dose limiting toxicity with the combination of selpercatinib and 131I therapy, graded according to CTCAE v5.
Determine the safety of the combination of selpercatinib given for 6-months followed by 131I therapy in patients with RET fusion differentiated thyroid cancer
Time frame
12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Children's Hospital of Philadelphia
Lead sponsor
Eli Lilly and Company
Collaborator
United States Department of Defense
Collaborator
Source ClinicalTrials.gov