Gender-based Impact on Safety and Efficacy of Lenvatinib in Patients With Differentiated Thyroid Cancer

Lenvatinib is approved for the treatment of radioiodine refractory differentiated thyroid cancer. Despite gender can play a crucial role un in safety and efficacy of oncological product, little is know on gender difference in lenvatinb effacacy and safety in the context of radioiodine refractory differentiated thyroid cancer. The primary objective of the study is to assess safety and toxicity profile in male and female patients in terms of dose reduction. The secondary objectives are to assess sex and gender difference in: the number and the incidence of adverse events; response rate according to RECIST criteria 1.1; progression free survival, overall survival and duration of response.

NCT Number	NCT05789667
Lead Sponsor	Regina Elena Cancer Institute Collaborators: University of Turin, Italy, University of Roma La Sapienza, University of Siena, University of Pisa, Istituto Oncologico Veneto IRCCS, University of Catania, Istituto Auxologico Italiano
Conditions	Differentiated Thyroid Cancer, Gender
Enrollment	50 participants
Start Date	2020-05-27
Primary Completion	2024-12-01 (estimated)
Study Completion	2025-12-31 (estimated)
Updated on ClinicalTrials.gov	2024-12-06