GR018: Randomized phase II study of NGR-hTNF plus an anthracycline versus an anthracycline alone in platinum-resistant ovarian cancer - NGR018

MolMed S.p.A.0 个研究点目标入组 24 人开始时间: 2013年2月7日最近更新: 2016年3月14日

适应症

试验速览

暂无简介。

•1. Age = 18 years
•2. Histologically-proven ovarian cancer, fallopian tube and primary peritoneal cancer in advanced or metastatic stage
•3. Patients previously treated with a maximum of two platinum-based regimen (cisplatin or carboplatin) plus paclitaxel and with documented progressive disease on treatment (refractory patient population) or within 6
•months from last chemotherapy cycle (resistant patient population)
•4. ECOG Performance status 0 - 2 (Appendix A)
•5. Life expectancy of 12 weeks or more
•6. Normal cardiac function (LVEF = 50%) and absence of uncontrolled hypertension
•7. Adequate baseline bone marrow, hepatic and renal function
•8. At least one (not previously irradiated) target lesion
•that could be measured in one dimension, or nonmeasurable
•disease only, according to RECIST criteria
•9. Patients may have had prior therapy 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 21 days
•10. 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 18
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 6

•1. Patients must not receive any other investigational agents while on study
•2. More than two previous chemotherapy lines and previous treatment with anthracycline
•3. 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
•4. Prolonged 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 hampering compliance with the study protocol
•9. Pregnancy or lactation.

发起方

MolMed S.p.A.