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

NCT05789667 | Recruiting FDA Drug

• 1 other identifier: RS1316/20(2312)
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Gender difference in Safety profile of lenvatinib treatment

  Difference in lenvatinib dose reduction between male and female patients

  1 year

Secondary Outcomes (3)

• Gender difference in lenvatinib side effects incidence

  1 year

• Gender difference in lenvatinib response rate

  1 year

• Gender difference progression free survival and overall survival of patients treated with lenvatinib

  1 year

Interventions

Lenvatinib DRUG

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

Also known as: lenvatinib mesilate, Lenvatinib Oral Capsule [Lenvima]

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients affected by radio-refractory iodine differentiated thyroid cancer

You may qualify if:

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

You may not qualify if:

• \- Age \< 18 years

Sponsors & Collaborators

• Regina Elena Cancer Institute: lead
• 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

Study Sites (1)

Regina Elena National Cancer Institute

Rome, 00144, Italy

RECRUITING

MeSH Terms

Conditions

Coitus

Interventions

lenvatinib

Condition Hierarchy (Ancestors)

Sexual Behavior; Behavior

Study Officials

• Marialuisa Appetecchia, Prof

  Regina Elena Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marialuisa Appetecchia, Prof

CONTACT

00390652666026; marialuisa.appetecchia@ifo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 16, 2023
• First Posted: March 29, 2023
• Study Start: May 27, 2020
• Primary Completion: December 1, 2024
• Study Completion: December 31, 2025
• Last Updated: December 6, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Time Frame: At the end of the study
• Access Criteria: Open access

Locations

IT (1)