E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with malignant pleural mesothelioma |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10059518 |
E.1.2 | Term | Pleural mesothelioma malignant |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To investigate the activity and safety of the combination of cetuximab and platinum/pemetrexed as first line treatment in EGFR IHC positive mesothelioma patients. |
|
E.2.2 | Secondary objectives of the trial |
To perform a translational research program to evaluate the possible use of EGFR FISH and K-ras mutations and other biomarkers to predict response to cetuximab in patients with MPM. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Histological proven malignant pleural mesothelioma, epitheloid subtype - Recurrent after radical surgery or disease not considered suitable for radical treatment - EGFR IHC + as assessed by DAKO kit with at least 1% of cells showing staining - Performance status WHO 0 or 1 - Life expectancy > 12 weeks - Weight loss < 10% in last 3 months - Adequate bone marrow reserve (ANC count > 1.5 x 109 /L, platelets > 100 x 109/L) - Creatinine clearance: > 60 mL/min (Cockroft and Gault) or > 50 mL/min (51Cr-EDTA) - Adequate hepatobiliary function (ALT/AST) < 2.5 x upper limit of normal range (ULN) or < 5 x ULN for patients with liver metastases, bilirubin < 1.5 x ULN) - Measurable disease (modified RECIST, see Section X on "evaluation of response") - No prior chemotherapy - No prior or other malignancies, except if longer than 5 yrs ago and adequately treated or basocellular skin or in situ cervical cancer - No uncontrolled infection - Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial - Written informed consent according to ICH/GCP, and national/local regulations - age of 18 years or older |
|
E.4 | Principal exclusion criteria |
- Evidence of brain or leptomeningeal metastases - Patients with pre-existing peripheral neuropathy - Patients who are unable to interrupt aspirin or other nonsteroidal anti-inflammatory drugs, for a 5-day period starting 2 days before administration of pemetrexed (8-day period for long acting agents such as piroxicam). - Patients that cannot be treated with folic acid and vit B 12 - Patients that cannot be treated with dexamethasone. - Presence of clinically detectable (by physical examination) third-space fluid collections, for example ascites or pleural effusions that cannot be controlled by drainage or other procedures prior to the study entry. - Use of investigational drugs - Female patients who are lactating or child bearing potential without adequate contraceptive measures |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Progression free survival rate (PFSR) at 18 weeks. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 5 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
Cetixumab should be continued until disease progression. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |