A phase II study of the association of Glivec (imatinib mesylate, formerly known as STI 571) plus Gemzar (gemcitabine) in patients with unresectable, refractory, malignant mesothelioma expressing either PDGFR-beta or C-Kit. - ND

• Conditions: malignant mesothelioma expressing either PDGFR-beta or c-kit; MedDRA version: 9.1Level: LLTClassification code 10027408Term: Mesothelioma malignant advanced; MedDRA version: 9.1Level: LLTClassification code 10027411Term: Mesothelioma malignant recurrent

• Registration Number: EUCTR2007-006346-17-IT
• Lead Sponsor: Gruppo Italiano Mesotelioma (G.I.Me.)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03-10
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

age of > 18 years and < 72 years, patients with a histologically proven malignant mesothelioma of the pleura or of the peritoneum*, expressing either PDFGR-beta or C-Kit by immunochemistry (ICH),locally advanced disease, unsuitable for curative surgical resection, or metastatic disease, confirmed progression of the disease according to modified RECIST criteria, documented after, at least, one first-line, systemic, or local (i.e., intrapleuric), treatment; life expectancy of at least 3 months, capability of understanding the objectives of the study and giving written informed consent, willingness and ability to comply with study requirements,sufficient caloric and fluid intake, including patients under enteral or parenteral nutrition
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

co-existing tumors of different histologic origin, except non melanomatous localized skin cancer and/or in situ cervical carcinoma, a history of earlier tumors of different histologic origin being in complete remission since less than 5 years, unresolved toxicity from prior antitumor treatment(s), primary peritoneal mesothelioma

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: efficacy, i.e., response rate to study drugs;Secondary Objective: duration of response<br>time to progression<br>toxicity profile<br>overall survival;Primary end point(s): overall response rate