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
- 14
- 试验地点
- 4
- 主要终点
- Safety according to NCI-CTCAE criteria (version 4.03)
研究概览
简要总结
The primary objective of this extension protocol is to evaluate the early safety of a new schedule of NGR-hTNF given weekly, instead of every 3 or 4 weeks, in a cohort of 12 patients randomized to the experimental arm A, as compared to a reference cohort of 12 patients randomized to an anthracycline alone
详细描述
In this extension protocol IPR/26 of completed IPR/24 study, considering the relatively short half-life of approximately 1 hour and the favourable toxicity profile of NGR-hTNF, characterized by transient constitutional symptoms occurring during the first day of administration, an additional cohort of 24 patients will be randomized and the 12 patients enrolled in arm A will receive the same dose of NGR-hTNF 0.8 mcg/m2 given as 60 minutes infusion every week. the weekly schedule of NGR-hTNF 0.8 mcg/m2 has previously been tested in several studies
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 and absence of uncontrolled hypertension
- •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 or contraindications 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
Safety according to NCI-CTCAE criteria (version 4.03)
时间窗: from the start of treatment until 28 days after last treatment
To evaluate safety profile related to NGR-hTNF
次要结局
- Progression-Free Survival (PFS)(from randomization date, every 6-8 weeks based on chemotherapy during treatment and every 12 weeks during follow-up until first documented PD or death from any cause, whichever came first, assessed up through study completion, approximately 12 months)
- Overall survival (OS)(from randomization date, every 6-8 weeks based on type of chemotherapy during treatment and every 12 weeks during follow-up until date of death, from any cause, assessed up through study completion, approximately 12 months)
- Response Rate (RR)(from randomization date, every 6-8 weeks based on chemotherapy during treatment and every 12 weeks during follow-up until first documented PD or death from any cause, whichever came first, assessed up through study completion, approximately 12 months)
- Disease Control Rate (DCR)(from randomization date, every 6-8 weeks based on chemotherapy during treatment and every 12 weeks during follow-up until first documented PD or death from any cause, whichever came first, assessed up through study completion, approximately 12 months)
- Duration of Disease Control(from randomization date, every 6-8 weeks based on chemotherapy during treatment and every 12 weeks during follow-up until first documented PD or death from any cause, whichever came first, assessed up through study completion, approximately 12 months)