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Trial Title:
Gender-based Impact on Safety and Efficacy of Lenvatinib in Patients With Differentiated Thyroid Cancer
NCT ID:
NCT05789667
Condition:
Differentiated Thyroid Cancer
Gender
Conditions: Official terms:
Thyroid Neoplasms
Thyroid Diseases
Lenvatinib
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Drug
Intervention name:
Lenvatinib
Description:
Patients will be treated by lenvatinib as recommended by good clinical practice
Other name:
lenvatinib mesilate
Other name:
Lenvatinib Oral Capsule [Lenvima]
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.
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.
Criteria for eligibility:
Study pop:
Patients affected by radio-refractory iodine differentiated thyroid cancer
Sampling method:
Probability Sample
Criteria:
Inclusion Criteria:
- Patients with refractory iodine DTC treated with lenvatinib
- Signed written informed consent
Exclusion Criteria:
- Age < 18 years
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Regina Elena National Cancer Institute
Address:
City:
Rome
Zip:
00144
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Marialuisa Appetecchia, MD
Phone:
0039 0652666026
Email:
marialuisa.appetecchia@ifo.it
Start date:
May 27, 2020
Completion date:
December 31, 2024
Lead sponsor:
Agency:
Regina Elena Cancer Institute
Agency class:
Other
Collaborator:
Agency:
University of Turin, Italy
Agency class:
Other
Collaborator:
Agency:
University of Roma La Sapienza
Agency class:
Other
Collaborator:
Agency:
University of Siena
Agency class:
Other
Collaborator:
Agency:
University of Pisa
Agency class:
Other
Collaborator:
Agency:
Istituto Oncologico Veneto IRCCS
Agency class:
Other
Collaborator:
Agency:
University of Catania
Agency class:
Other
Collaborator:
Agency:
Istituto Auxologico Italiano
Agency class:
Other
Source:
Regina Elena Cancer Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05789667
