A Multicenter, Open-label, Single-arm Study of the Efficacy and Safety of Intravenous AVE0005 (VEGF Trap) Administered Every 2 Weeks in Advanced Ovarian Cancer Patients With Recurrent Symptomatic Malignant Ascites
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Percentage of Participants With a Repeat Paracentesis Response (RPR)
研究概览
简要总结
The primary objective of this study was to compare the time between paracenteses before and after administration of Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®) in ovarian cancer participants with symptomatic malignant ascites.
The secondary objectives were to further assess efficacy and safety of Aflibercept treatment, and the exploratory objectives were to assess pharmacokinetics, immunogenicity and health-related quality of life.
详细描述
The study consisted of:
- A 30-day screening phase prior to Day 1
- Day 1 registration and pre-treatment paracentesis
- Aflibercept administration within 1-day of registration
- Two-week study treatment cycles (for efficacy data, the cut-off date was 6 months post-registration
- A 60-day post-treatment follow-up phase
During the study, participants were treated with Aflibercept study treatment through the duration of the study unless they met one the following criteria for discontinuation:
- Participant (or legal representative) chose to withdraw from treatment
- The investigator or sponsor thought that continuation of the study would be detrimental to the participants well-being
- Participant had intercurrent illness that prevented further administration of investigational product (IP)
- Participant had more than 2 IP dose reductions
- Participant had unacceptable adverse events (AEs)
- Participant had arterial thromboembolic events, including cerebrovascular accidents, myocardial infarctions, transient ischemic attacks, new onset angina, or worsening of preexisting angina
- Participant required surgical intervention for intestinal obstruction or gastrointestinal perforation
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Symptomatic malignant ascites resulting from advanced ovarian epithelial cancer (including fallopian tube and primary peritoneal adenocarcinoma) that required at least 3 previous therapeutic paracenteses at a frequency of 1 to 4 paracenteses per month for management.
- •Platinum resistant disease defined by relapse or progression of disease during or after treatment, or drug intolerance.
- •Topotecan- and/or liposomal doxorubicin-resistant disease defined by relapse or progression of disease during or after treatment, or drug intolerance.
排除标准
- •Peritoneovenous or other type of shunt that was placed for the management of ascites
- •Prior treatment with a VEGF or VEGF receptor inhibitor
- •Uncontrolled hypertension
- •The above information is not intended to contain all considerations relevant to participation in a clinical trial.
研究组 & 干预措施
Aflibercept
Participants with advanced ovarian epithelial cancer (including fallopian tube and primary peritoneal adenocarcinoma) treated with Aflibercept every 2 weeks until a criterion for treatment discontinuation was met
干预措施: Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®) (Drug)
结局指标
主要结局
Percentage of Participants With a Repeat Paracentesis Response (RPR)
时间窗: up to 2 years post-registration
RPR was defined as at least a two-fold increase in the time to repeat paracentesis (TRP) as compared to the average duration of the 2 intervals between the 3 most recent paracenteses prior to study registration (ie, the baseline interval of paracentesis). Percentage of participants with a repeat paracentesis response were the number of participants with RPR / number of total participants \* 100.
次要结局
- Overall Survival (OS) Time(up to 6 months post-registration)
- Time to Repeat Paracentesis (TRP)(up to 6 months from registration)
- 60-day Frequency of Paracentesis (FOP)(up to 60 days post-registration)
- Progression-free Survival (PFS) Time(up to 6 months post-registration)
- Safety - Number of Participants With Adverse Events (AE)(up to 60 days after last dose of treatment (approximately 2 years), or until TEAE was resolved or stabilized)
- Number of Participants With a Positive Anti-drug Antibody Response(up to 60 days after the last dose of treatment)