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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRegina Elena Cancer Institute

About this trial

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.

Eligibility criteria

Qualifiers

Patients with refractory iodine DTC treated with lenvatinib

Signed written informed consent

Disqualifiers

None

Trial design

Treatments tested in this trial

  • Lenvatinib

Treatment groups

No treatment groups listed

Sponsors and collaborators

Regina Elena Cancer Institute

Lead sponsor

University of Turin, Italy

Collaborator

University of Roma La Sapienza

Collaborator

University of Siena

Collaborator

University of Pisa

Collaborator

Istituto Oncologico Veneto IRCCS

Collaborator

University of Catania

Collaborator

Istituto Auxologico Italiano

Collaborator