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Pharmacogenetics Of Vinorelbine In Malignant Pleural Mesothelioma Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01865045
Recruitment Status : Unknown
Verified February 2017 by Armando Santoro, MD, Istituto Clinico Humanitas.
Recruitment status was:  Active, not recruiting
First Posted : May 30, 2013
Last Update Posted : February 10, 2017
Information provided by (Responsible Party):
Armando Santoro, MD, Istituto Clinico Humanitas

Brief 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

Condition or disease
Malignant Pleural Mesothelioma

Detailed 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.

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Pharmacogenetics of Vinorelbine in Malignant Pleural Mesothelioma Patient
Study Start Date : November 2012
Actual Primary Completion Date : December 2016
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mesothelioma
Drug Information available for: Vinorelbine

no treatment
no treatment

Primary Outcome Measures :
  1. Expression of TUBB3 and BRCA1 in MPM tumor tissue by immunohistochemistry and RT-PCR. [ Time Frame: 2 months ]

Secondary Outcome Measures :
  1. Association of expression of TUBB3 and BRCA1 with clinical outcome (response, survival) . [ Time Frame: 2 months ]

Biospecimen Retention:   Samples Without DNA

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Malignant pleural mesothelioma patients treated with vinorelbine as a second or later line chemotherapy with at least an objective response evaluation.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01865045

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Istituto Clinico Humanitas
Rozzano, Milan, Italy, 20089
Sponsors and Collaborators
Armando Santoro, MD
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Principal Investigator: armando santoro, MD Istituto Clinico Humanitas

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Responsible Party: Armando Santoro, MD, Principal Investigator, Istituto Clinico Humanitas Identifier: NCT01865045     History of Changes
Other Study ID Numbers: ONC/OSS-02/2012
First Posted: May 30, 2013    Key Record Dates
Last Update Posted: February 10, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: not planned
Additional relevant MeSH terms:
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Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Mesothelial
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action