Study of efficacy and safety of the compound NGR-hTNF in patient with advanced malignant pleural mesothelioma
- Conditions
- Advanced malignant pleural mesothelioma previuosly treated with a pemetrexed based chemotherapy regimenMedDRA version: 14.1Level: PTClassification code 10035605Term: Pleural mesothelioma malignant advancedSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2009-016879-29-SE
- Lead Sponsor
- MOLMED
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 390
1.Age = 18 years
2. Histologically or cytological confirmed malignant pleural mesothelioma of any of the following subtype:
epithelial, sarcomatoid, mixed, or unknown
3. Prior treatment with no more than one sistemic pemetrexed-based chemotherapy regimen administered
for advanced or metastatic disease. Prior use of a biological agent in combination with a pemetrexed based
regimen and prior administration of intrapleural cytotoxic agents are allowed.Patients who have previously received anthracyclines should not receive doxorubicin.
4. ECOG Performance Status 0 - 2
5. Life expectancy of =12 weeks
6. Adequate baseline bone marrow, hepatic and renal function, defined as follows:
a. Neutrophils = 1.5 x 109/L; platelets = 100 x 109/L; hemoglobin = 9 g/dL
b. Bilirubin = 1.5 x ULN
c. AST and/or ALT = 2.5 x ULN in absence of liver metastasis or = 5 x ULN in presence of liver metastasis
d. Serum creatinine < 1.5 x ULN
7. Measurable or non-measurable disease according to MPM-modified RECIST criteria
8. Patients may have had prior therapy providing the following conditions are met:
a. Surgery: wash-out period of 14 days
b.Systemic anti-tumor and radiation therapy: wash-out period of 28 days
9. Patients must give written informed consent to participate in the study
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 390
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 390
1. Patients must not receive any other investigational agents while on study
2. Patients with myocardial infarction within the last six months, unstable angina, New York Heart association (NYHA) grade II or greater congestive heart failure, or serious cardiac arrhythmia requiring medication
3. Uncontrolled hypertension
4. QTc interval (congenital or acquired) > 450 ms
5. History or evidence upon physical examination of CNS disease unless adequately treated (e.g., primary brain tumor, any brain metastasis, seizure not controlled with standard medical therapy, or history of stroke)
6. Patients with active or uncontrolled systemic disease/infections or with serious illness or medical conditions, which is incompatible with the protocol
7. Known hypersensitivity/allergic reaction to human albumin preparations or to any of the excipients
8. Any psychological, familial, sociological or geographical condition potentially tampering compliance with the study protocol
9. Pregnancy or lactation.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To compare overall survival (OS) in patients randomized to NGR-hTNF plus BIC versus patients randomized to placebo plus BIC;Secondary Objective: -To compare progression-free survival (PFS)<br>-To compare disease control rate (DCR, defined as the percentage of patients who have a best response rating of complete or partial response or stable disease, according to MPM-modified RECIST criteria)<br>-To compare duration of disease control<br>-To evaluate safety and toxicity profile related to NGR-hTNF<br>-To assess changes in quality of life (QoL) in the two treatment arms<br>-To evaluate medical care utilization in the two treatment arms;Primary end point(s): To compare overall survival (OS) in patients randomised to NGR-hTNF plus BIC (Best Investigator Choice) versus patients randomised to placebo plus BIC.;Timepoint(s) of evaluation of this end point: Time from the date of randomization until the date of death due to any cause or the last date the patient was known to be alive.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): - Progression-free survival (PFS)<br>- Disease control rate (DCR)<br>- Duration of disease control<br>- Safety<br>- Quality of life (QoL)<br>- Medical Care Utilization (MCU);Timepoint(s) of evaluation of this end point: - Progression-free survival (PFS): time from the date of randomization until disease progression, or death due to any cause<br>