Combination of Gemcitabine and Imatinib Mesylate in Pemetrexed-pretreated Patients With Pleural Mesothelioma

Mesothelioma, Malignant Clinical Trial

Official title: A Phase II Study of the Combination of Gemcitabine and Imatinib Mesylate in Pemetrexed-pretreated Patients With Malignant Pleural Mesothelioma

Status Completed

Clinical Trial Summary

This is a phase II, monocentric study of the combination of gemcitabine and imatinib mesylate in pemetrexed-pretreated patients with MPM expressing PDGFR-beta and/or C-kit by Immunohistochemistry (IHC). Treatment will be done until disease progression, or patient refusal or withdrawal of patient consent, or unacceptable toxicity

Clinical Trial Description

Pemetrexed-pretreated patients with MPM expressing PDGFR-beta and/or C-kit by IHC will receive chemotherapy as follow :

• Gemcitabine 1000 mg/m2, i.v., days 3 and 10 of a 21-days schedule;

• Imatinib mesylate 400 mg/die orally on days 1-5 and 8-12 of a 21-days schedule.

Treatment repeats every 21 days in the absence of disease progression, patient refusal or withdrawal of patient consent, or unacceptable toxicity.

The molecular profile of patients enrolled will be evaluated with Ion Personal Genome Machine (PGM) Torrent Next-generation Sequencing platform in order to individuate potential predictive biomarkers and to improve the understanding of the molecular biology of these rare tumors. A correlation among the molecular profiles identified, clinical characteristics, and survival data of patients will be done ;

Related Conditions & MeSH terms

• Mesothelioma
• Mesothelioma, Malignant

• NCT number: NCT02303899
• Study type: Interventional
• Source: Istituto Clinico Humanitas
• Status: Completed
• Phase: Phase 2
• Start date: November 2014
• Completion date: December 2017