GR015: Randomized double-blind phase III study ofNGR-hTNF plus best investigator’s choice (BIC) versusplacebo plus BIC in previously treated patients withadvanced malignant pleural mesothelioma (MPM) - NGR015
- Conditions
- Advanced malignant pleural mesothelioma previously treated with a pemetrexed based chemotherapy regimenMedDRA version: 12.1Level: LLTClassification code 10035605Term: Pleural mesothelioma malignant advanced
- Registration Number
- EUCTR2009-016879-29-IE
- Lead Sponsor
- MOLMED
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 390
1. Age = 18 years
2. Histological 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 systemic 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
4. ECOG Performance Status 0 - 2 (Appendix A)
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 treatment providing the following conditions are met:
a. Surgery and radiation therapy: wash-out period of 14 days
b. Systemic anti-tumor 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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
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 or contraindications to human albumin preparations or to any of the excipients
8. Any psychological, familial, sociological or geographical condition potentially hampering 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 (Best Investigator Choice) 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 randomized to NGR-hTNF plus BIC (Best Investigator Choice) versus patients randomized to placebo plus BIC
- Secondary Outcome Measures
Name Time Method