A PHASE II STUDY OF THE COMBINATION OF GEMCITABINE AND IMATINIB MESYLATE IN PRETREATED PATIENTS WITH MALIGNANT PLEURAL MESOTHELIOMA

• Conditions: Malignant Pleural Mesothelioma; MedDRA version: 17.0Level: PTClassification code 10059518Term: Pleural mesothelioma malignantSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2014-002876-10-IT
• Lead Sponsor: Istituto Clinico Humanitas

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09-11
• Last Update Posted: 9 March 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1) Age of > 18 years.
2) Patients with a histologically proven malignant
mesothelioma of the pleura, expressing PDFGR-beta
and/or C-Kit by immunochemistry (ICH).
3) Locally advanced disease, unsuitable for curative surgical
resection, or metastatic disease.
4) Confirmed progression of the disease according to
modified RECIST-criteria, documented after a
pemetrexed-based chemotherapy.
5) ECOG Performance Status of 0, 1 or 2.
6) Life expectancy of at least 3 months.
7) Written informed consent.
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 30
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1) Co-existing tumors of different histologic origin, except
non melanomatous localized skin cancer and/or in situ
cervical carcinoma.
2) A history of earlier tumors of different histologic origin
being in complete remission since less than 5 years.
3) Unresolved toxicity from prior antitumor treatment(s).
4) Primary peritoneal mesothelioma.
5) Any of the following abnormal baseline hematological
values:
a. Hb < 9 g/dL
b. WBC < 3 x 10^9/L
c. Neutrophils < 1.5 x 10^9/L
d. Platelets < 100 x 10^9/L
e. Serum bilirubin > 2.5 mg/dL
f. ALAT and ASAT > 3 x UNL (unless due to liver
metastases)
g. Serum creatinine > 1.5 mg/dL.
6) Symptomatic and/or unstable pre-existing brain
metastases. To be enrolled in the study, subjects must
have confirmation of stable disease by MRI or computer tomography (CT) scan within 4 weeks from day 1 of cycle 1 of treatment and have CNS metastases well controlled by steroids, anti – epileptics or other symtom-relieving medications.
7)Clinically relevant cardiovascular disease, i.e., myocardial infarction or other severe coronary artery diseases within the prior 6 months, cardiac arrythmia requiring medication, uncontrolled hypertension, overt cardiac failure or non compensated chronic heart disease in NYHA class II or more.
8)History of psychiatric disabilities, potentially interfering with the capability of giving adequate informed consent.
9)Pregnant or lactating women or inability/unwillingness to practice a medically approved method of contraception during study period (including 3 months following the end of treatment)
10)Uncontrolled active infections.
11)Any condition which, in the judgement of the Investigator, would place the patient at undue risk or interfere with the results of the study.

Study & Design

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