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

MOLMED0 个研究点目标入组 96 人开始时间: 2010年7月15日最近更新: 2016年6月13日

适应症

试验速览

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•- 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

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