Malignant Pleural Mesothelioma MedDRA version: 17.0 Level: PT Classification code 10059518 Term: Pleural mesothelioma malignant System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Glivec
Product Name: imatinib mesylate
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: IMATINIB MESYLATE
CAS Number: 220127-57-1
Concentration unit: mg milligram(s)
Concentration t
Sponsors
Istituto Clinico Humanitas
Eligibility
Sex/Gender
All
Inclusion criteria
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
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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - To assess the anti-tumor activity of IM in combination with GEM, in terms of 3-months progression-free survival (PFS) rate. ;Secondary Objective: - To assess anti-tumor activity of IM in combination Protocol ONC-2014-002 Version/Date: 1.0/ 03 Sep 2014 11 with GEM, in terms of objective response rate according to RECIST criteria (Modified RECIST criteria for Malignant Pleural Mesothelioma), and duration of response. - To assess anti-tumor activity of IM in combination with GEM, in terms of PFS and overall survival (OS) - To determine the safety profile of IM in combination with GEM. - To evaluate the molecular profile of patients enrolled with Ion PGM Torrent Next-generation Sequencing platform correlating the molecular profiles identified with clinical characteristics and survival data of patients.;Primary end point(s): - To assess the anti-tumor activity of IM in combination with GEM, in terms of 3-months progression-free survival (PFS) rate. ;Timepoint(s) of evaluation of this end point: March 2018 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •- To assess anti-tumor activity of IM in combination with GEM, in terms of objective response rate according to RECIST criteria (Modified RECIST criteria for Malignant Pleural Mesothelioma), and duration of response. •- To assess anti-tumor activity of IM in combination with GEM, in terms of PFS and overall survival (OS) •- To determine the safety profile of IM in combination with GEM. •- To evaluate the molecular profile of patients enrolled with Ion PGM Torrent Next-generation Sequencing platform correlating the molecular profiles identified with clinical characteristics and survival data of patients. ;Timepoint(s) of evaluation of this end point: November 2018 | — |
Countries
Italy
Contacts
Public ContactCRO
EMMEDI Srl Divisione Solaris
Outcome results
None listed