NCT00484432已完成2 期
NGR012: A Phase II Study of NGR-hTNF Administered in Combination With Doxorubicin Every 3 Weeks in Patients Affected by Advanced or Metastatic Ovarian Cancer
AGC Biologics S.p.A.2 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2008年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- Antitumor activity defined as response rate
研究概览
简要总结
The main objective of the trial is to document the response rate in patients affected by metastatic ovarian cancer, treated with NGR-hTNF plus doxorubicin. Safety will be established by clinical and laboratory assessment according to NCI-CTC criteria.
详细描述
This is a phase II, open-label,single arm, non-randomized study that will be conducted in patients affected by metastatic ovarian cancer, that will be conducted using Simon's two-stage design method.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients ≥18 years old affected by advanced or metastatic ovarian cancer previously treated with platinum regimens (cis or carboplatin) plus paclitaxel and with documented progression disease within 6 months from last chemotherapy administered (refractory/resistant population) or in progression disease after 6 months from last chemotherapy (platinum regimens plus paclitaxel) administered
- •Rechallenge with platinum regimens
- •No previous exposure to anthracyclines
- •Histologically or cytologically confirmed ovarian carcinoma
- •Life expectancy more than 3 months
- •ECOG Performance status 0 - 1
- •Normal cardiac function (LVEF ≥55%) and absence of uncontrolled hypertension
- •Measurable disease defined as ≥1 unidimensional measurable lesion ≥ 20 mm by conventional technics or ≥ 10 mm ( spiral CT scan or PET); ascites is allowed if present with peritoneal carcinosis
- •Adequate baseline bone marrow, hepatic and renal function, defined as follows:
- •Neutrophils > 1.5 x 10^9/L and platelets > 100 x 10^9/L
- •Bilirubin < 1.5 x ULN
- •AST and/or ALT < 2.5 x ULN in absence of liver metastasis
- •AST and/or ALT < 5 x ULN in presence of liver metastasis
- •Serum creatinine < 1.5 x ULN
- •Patients may have had prior therapy providing the following conditions are met:
- •Chemotherapy and radiotherapy: wash-out period of 28 days
- •Surgery: wash-out period of 14 days
- •Absence of any conditions in which hypervolaemia and its consequences (e.g. increased stroke volume, elevated blood pressure) or haemodilution could represent a risk for the patient (take as reference "Technical data sheet human albumin" specifically used in Pharmacy Department for NGR-hTNF dilution)
- •Patients must give written informed consent to participate in the study
- •Exclusion criteria:
- •Concurrent anticancer therapy
- •Patients must not receive any other investigational agents while on study
- •New York Heart Association class II-IV cardiac disease
- •Acute angina
- •Patients with myocardial infarction within the last six (6) months
- •Patient with significant peripheral vascular disease
- •Thrombosis of main portal vein
- •Clinical signs of CNS involvement
- •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 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.
排除标准
- 未提供
研究组 & 干预措施
A: NGR-hTNF + doxorubicin
Experimental
NGR-hTNF plus doxorubicin
干预措施: NGR-hTNF (Drug)
A: NGR-hTNF + doxorubicin
Experimental
NGR-hTNF plus doxorubicin
干预措施: doxorubicin (Drug)
结局指标
主要结局
Antitumor activity defined as response rate
时间窗: during the study
Evaluated according to Response evaluation criteria in solid tumors (RECIST)
次要结局
- Progression Free Survival (PFS)(during the study)
- CA125 (U/mL) measurement(from the randomization, every 6 weeks until the end of treatment)
- Safety according to NCI-CTCAE criteria (version 3)(during the study)
- Overall survival (OS)(from the date of randomization to the date of death, assessed up to 6 months)
研究者
研究点 (2)
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