NCT02303899

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Istituto Clinico Humanitas · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed 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

Conditions

• Mesothelioma, Malignant

Interventions

Type	Name	Description
DRUG	Gemcitabine	infusion drug
DRUG	Imatinib mesylate	oral drug

Timeline

• Start date: 2014-11-01
• Primary completion: 2015-12-01
• Completion: 2017-12-01
• First posted: 2014-12-01
• Last updated: 2021-01-22

Locations

1 site across 1 country: Italy