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

RECRUITINGSponsored by Regina Elena Cancer Institute
Actively Recruiting
SponsorRegina Elena Cancer Institute
Started2020-05-27
Est. completion2024-12-01
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT05789667

Summary

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

Age: 18 Years+Healthy volunteers accepted
Inclusion Criteria:

* Patients with refractory iodine DTC treated with lenvatinib
* Signed written informed consent

Exclusion Criteria:

\- Age \< 18 years

Conditions3

CancerDifferentiated Thyroid CancerGender

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