EUCTR2009-016879-29-BEActive, not recruitingPhase 1
GR015: Randomised double-blind phase III study of NGR-hTNF plus best investigator's choice (BIC) versus placebo plus BIC in previously treated patients with advanced malignant pleural mesothelioma (MPM) - NGR015
MOLMED0 sites390 target enrollmentStarted: December 13, 2011Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 390
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Investigators
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