GR016: Randomized phase II study evaluating two doses of NGR-hTNF administered either as single agent or in combination with doxorubicin in patients with advanced soft-tissue sarcoma (STS). - NGR016
- Conditions
- MedDRA version: 9.1Level: HLGTClassification code 10041299ocally advanced or metastatic STS patients untreated or previously treated with one or more prior systemic regimen.
- Registration Number
- EUCTR2010-018851-88-IT
- Lead Sponsor
- MOLMED
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 96
- Patients =18 years - Histologically-proven, locally advanced, or metastatic STS (excluding extraosseus Ewing sarcoma) - Patients not amenable to surgery, radiotherapy, or combined-modality therapy with curative intent - Patients untreated or previously treated with one or more systemic regimen - ECOG Performance status 0-2 (Appendix A) - At least one untreated (not previously irradiated) target lesion that could be measured in one dimension, according to RECIST criteria - A life expectancy of 12 weeks or more - Adequate baseline bone marrow, hepatic and renal function, defined as follows: Neutrophils > 1.5 x 109/L and platelets > 100 x 109/L; Bilirubin < 1.5 x ULN; AST and/or ALT < 2.5 x ULN in absence of liver metastasis or < 5 x ULN in presence of liver metastasis; Serum creatinine < 1.5 x ULN; Creatinine clearance (estimated according to Cockcroft-Gault formula, Appendix A) = 50 ml/min - Patients may have had prior treatment providing the following conditions are met before treatment start: - Surgery and radiation therapy: wash-out period of 14 days; Systemic therapy: wash-out period of 21 days - Patients must give 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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
- Patients may not receive any other investigational agents while on study - 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 - LVEF < 55% (only for patients candidate for doxorubicin treatment) - Uncontrolled hypertension - Prolonged QTc interval (congenital or acquired) > 450 ms - History or evidence upon physical examination of CNS disease unless adequately treated (e.g., primary brain tumour, any brain metastasis, seizure not controlled with standard medical therapy) or history of stroke - Patients with active or uncontrolled systemic disease/infections or with serious illness or medical conditions, which is incompatible with the protocol - Known hypersensitivity/allergic reaction to human albumin preparations or to any of the excipients - Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol - Pregnancy or lactation. Patients - both males and females - with reproductive potential (i.e. menopausal for less than 1-year and not surgically sterilized) must practice effective contraceptive measures throughout the study. Women of childbearing potential must provide a negative pregnancy test (serum or urine) within 14 days prior to registration
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method