NGR018: Randomized Phase II Study of NGR-hTNF Plus an Anthracycline Versus an Anthracycline Alone in Platinum-resistant Ovarian Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 119
- 试验地点
- 8
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
The primary objective of this randomized phase II trial is to compare progression-free survival (PFS) in patients randomized to NGR-hTNF plus an anthracycline versus patients randomized to an anthracycline alone
详细描述
Considering the safety/toxicity profile of NGR-hTNF characterized by mild-to-moderate constitutional symptoms, the reversibility of these adverse events generally occurring only during the infusion time; the absence of overlapping toxicities with chemotherapeutic agents; the safety and preliminary antitumor activity observed in previous trial with doxorubicin; and the objective response rate (RR) registered in a phase II trial in previously treated ovarian cancer patients seems justified to evaluate in a randomized phase II trial the efficacy of NGR-hTNF against a doxorubicin-based option in advanced ovarian cancer patients progressing or recurrent after a standard platinum/taxane-based chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Age ≥ 18 years
- •Histologically-proven ovarian cancer, fallopian tube and primary peritoneal cancer in advanced or metastatic stage
- •Patients previously treated with a maximum of two platinum-based regimen plus paclitaxel and with documented progressive disease on treatment (refractory patient population) or within 6 months from last chemotherapy cycle (resistant patient population)
- •ECOG Performance status 0 - 2
- •Life expectancy of 12 weeks or more
- •Normal cardiac function
- •Adequate baseline bone marrow, hepatic and renal function defined as follows:
- •Neutrophils ≥ 1.5 x 109/L; platelets ≥ 100 x 109/L; hemoglobin ≥ 9 g/dL
- •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
- •At least one (not previously irradiated) target lesion or non-measurable disease only, according to RECIST criteria
- •Patients may have had prior therapy providing the following conditions are met:
- •Surgery and radiation therapy: wash-out period of 14 days
- •Systemic anti-tumor therapy: wash-out period of 21 days
- •Patients must give written informed consent to participate in the study
排除标准
- •Patients must not receive any other investigational agents while on study
- •More than two previous chemotherapy lines and previous treatment with anthracycline
- •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
- •Prolonged QTc interval (congenital or acquired) > 450 ms
- •History or evidence upon physical examination of CNS disease unless adequately treated
- •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.
研究组 & 干预措施
Arm A: NGR-hTNF+ anthracycline
NGR-hTNF+Pegylated Liposomal Doxorubicin or Doxorubicin
干预措施: NGR-hTNF (Drug)
Arm A: NGR-hTNF+ anthracycline
NGR-hTNF+Pegylated Liposomal Doxorubicin or Doxorubicin
干预措施: Pegylated liposomal doxorubicin (Drug)
Arm A: NGR-hTNF+ anthracycline
NGR-hTNF+Pegylated Liposomal Doxorubicin or Doxorubicin
干预措施: Doxorubicin (Drug)
Arm B: anthracycline
Pegylated Liposomal Doxorubicin or Doxorubicin
干预措施: Pegylated liposomal doxorubicin (Drug)
Arm B: anthracycline
Pegylated Liposomal Doxorubicin or Doxorubicin
干预措施: Doxorubicin (Drug)
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: from the date of randomization, every 6 and 8 weeks based on type of chemotherapy during treatment and every 12 weeks during the follow-up until PD or death
Defined as the time from the date of randomization until disease progression, or death
次要结局
- Response Rate (RR)(from the date of randomization, every 6 and 8 weeks based on type of chemotherapy during treatment and every 12 weeks during the follow-up until PD or death)
- Disease Control Rate (DCR)(from the date of randomization, every 6 and 8 weeks based on type of chemotherapy during treatment and every 12 weeks during the follow-up until PD or death)
- Duration of Disease Control(from the date of randomization, every 6 and 8 weeks based on type of chemotherapy during treatment and every 12 weeks during the follow-up until PD or death)
- Safety and Toxicity according to NCI-CTCAE criteria (version 4.03)(from the start of treatment until 28 days after last treatment)
- Overall survival (OS)(from the date of randomization, every 6 and 8 weeks based on type of chemotherapy during treatment and every 12 weeks during follow-up until death)