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

NCT05789667 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2024-12-06

No results posted yet for this study

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.

Conditions

  • Differentiated Thyroid Cancer
  • Gender

Interventions

DRUG

Lenvatinib

Patients will be treated by lenvatinib as recommended by good clinical practice

Sponsors & Collaborators

  • University of Turin, Italy

    collaborator OTHER

  • University of Roma La Sapienza

    collaborator OTHER

  • University of Siena

    collaborator OTHER

  • University of Pisa

    collaborator OTHER

  • Istituto Oncologico Veneto IRCCS

    collaborator OTHER

  • University of Catania

    collaborator OTHER

  • Istituto Auxologico Italiano

    collaborator OTHER

  • Regina Elena Cancer Institute

    lead OTHER

Principal Investigators

  • Marialuisa Appetecchia, Prof · Regina Elena Cancer Institute

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-27
Primary Completion
2024-12-01
Completion
2025-12-31
FDA Drug
Yes

Countries

  • Italy

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05789667 on ClinicalTrials.gov