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

Sponsor

Regina Elena Cancer Institute (Other)

Overall Status

Recruiting

CT.gov ID

NCT05789667

Collaborator

University of Turin, Italy (Other), University of Roma La Sapienza (Other), University of Siena (Other), University of Pisa (Other), Istituto Oncologico Veneto IRCCS (Other), University of Catania (Other), Istituto Auxologico Italiano (Other)

Enrollment

Location

55.2

Anticipated Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Differentiated Thyroid Cancer Gender	Drug: Lenvatinib

Detailed Description

Lenvatinib is an orally available potent inhibitor of the split-kinase family of transmembrane growth factor receptors including Flt-1/VEGFR-1 and KDR/VEGFR. Lenvatinib has been investigated in hepatocellular carcinoma and in RAI-resistant thyroid cancer (Phase III trials) and in other malignancies, showing high rates of activity. In RAI-resistant thyroid cancer, lenvatinib showed a remarkable response rate over placebo (65% vs 2), combined with a prolonged progression free survival (18.3 vs 3.6 months). It has been approved for the treatment of locally recurrent or metastatic, progressive RAI resistance-DTC in the United States, Europe, and Japan, based on the results from SELECT trial. Moreover, lenvatinib demonstrated a meaningful clinical activity (response rate 64.8% in treatment arm vs 1.5% in placebo arm, p<0.001;) significantly reducing the tumour burden, with a median maximum percentage change in tumour size of -42.9%. Response was mostly pronounced at the first assessment (median -24.7% at 8 weeks after randomization) but it has been observed even in the following months (-1.3% per month). Recently, the efficacy of lenvatinib was confirmed in specific patient population, such as elderly. Although the efficacy is remarkable toxic effects are considerable and not all patients have the same risk to benefit ratio from lenvatinib treatment. Results derived from controlled clinical trials are rarely replicable in the real-life because these trials are usually conducted in selected populations, in a highly controlled setting, optimized to show the effect of the drug.

In this context growing evidences are showing gender associated functions playing a role in cancer incidence, progression and response to therapy; gender disparities in toxicities and effectiveness of certain drugs used in the treatment of the most common cancer is already well known.The aim of the present study is to evaluate the safety and efficacy profile of Lenvatinib based on gender in patients with refractory iodine DTC.

Study Design

Study Type:

Observational

Anticipated Enrollment :

50 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

May 27, 2020

Anticipated Primary Completion Date :

Jul 31, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Outcome Measures

Primary Outcome Measures

Gender difference in Safety profile of lenvatinib treatment [1 year]
Difference in lenvatinib dose reduction between male and female patients

Secondary Outcome Measures

Gender difference in lenvatinib side effects incidence [1 year]
Difference in number of lenvatinib side effects between male and female patients according to CTCAE 5.0
Gender difference in lenvatinib response rate [1 year]
Difference in lenvatinib response rate (CR+PR) according to RECIST response evaluation criteria 1.1 in male and female patients.
Gender difference progression free survival and overall survival of patients treated with lenvatinib [1 year]
Difference in progression free survival and overall survival of patients treated with lenvatinib in male and female patients.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

Age < 18 years

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Regina Elena National Cancer Institute	Rome		Italy	00144

Investigators

Principal Investigator: Marialuisa Appetecchia, Prof, Regina Elena Cancer Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Marialuisa Appetecchia, Professor, Regina Elena Cancer Institute

ClinicalTrials.gov Identifier:

NCT05789667

Other Study ID Numbers:

RS1316/20(2312)

First Posted:

Mar 29, 2023

Last Update Posted:

Mar 29, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Thyroid Neoplasms

Thyroid Diseases

Lenvatinib

Study Results

No Results Posted as of Mar 29, 2023