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NCT01865045 Clinical Trial

Pharmacogenetics Of Vinorelbine In Malignant Pleural Mesothelioma Patients

Malignant Pleural Mesothelioma Clinical Trial

Official title:
Pharmacogenetics of Vinorelbine in Malignant Pleural Mesothelioma Patient

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01865045
Other study ID # ONC/OSS-02/2012
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 2012
Est. completion date December 2017

Study information
Verified date September 2022
Source Istituto Clinico Humanitas
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This is a multicenter retrospective analysis .The aim of the present study is to investigate the molecular predictors of vinorelbine response in tumor samples of a series of MPM patients and evaluate the possible impact on clinical outcome. Sample size: around 150 patients based on the availability of tumor size

Description:

Vinorelbine has recently become an alternative option for palliation in selected pemetrexed-pretreated patients with malignant pleural mesothelioma (MPM). However, nowadays there are no definitive data about vinorelbine predictors of response in MPM patients. The identification of molecular predictors of effective therapy is important for maximizing therapeutic efficacy and minimizing useless treatment in cancer patients. In oncology a pharmacogenetic approach to customize the chemotherapy treatment according to individual as well as tumour genetic characteristics represents a modern and intriguing challenge. Recent studies have suggested that the expression levels of class III β-tubulin (TUBB3) or BRCA1, are related to a survival benefit from vinorelbine chemotherapy among patients with advanced solid malignancies, especially non-small cell lung cancer. There are no data about the predictive factors to vinorelbine in MPM patients. The identification of molecular predictors of effective therapy may allow in the future the development of better therapies.

Recruitment information / eligibility
Status Completed
Enrollment 150
Est. completion date December 2017
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - MPM patients treated with vinorelbine in the = second line setting will be retrospectively analyzed - Patients will be selected based on the availability of tumor tissue Exclusion Criteria: - NA

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Italy Istituto Clinico Humanitas Rozzano Milan

Sponsors (1)
Lead Sponsor Collaborator
Armando Santoro, MD

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Expression of TUBB3 and BRCA1 in MPM tumor tissue by immunohistochemistry and RT-PCR. 2 months
Secondary Association of expression of TUBB3 and BRCA1 with clinical outcome (response, survival) . 2 months
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