NCT00753480暂停1 期
A Phase I, Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of D4064A Administered Intravenously to Patients With Recurrent or Persistent Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer After a Platinum-Containing Regimen
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 暂停
- 入组人数
- 56
- 试验地点
- 3
- 主要终点
- Incidence and nature of dose-limiting toxicities (DLTs)
研究概览
简要总结
This is a Phase I, multicenter, open-label, dose-escalation study of single-agent D4064A administered by IV infusion to patients with recurrent or persistent epithelial ovarian cancer (EOC), primary peritoneal cancer (PPC), and fallopian tube cancer (FTC) who have previously received a platinum-containing regimen. The study will enroll up to 56 patients at up to six investigative sites in the United States.
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
- All
- 接受健康志愿者
- 否
入选标准
- •ECOG performance status of 0 or 1
- •Advanced, histologically documented epithelial ovarian, primary peritoneal, or fallopian tube cancer that has progressed or relapsed during or within 12 months of treatment with a platinum-containing chemotherapy regimen, and for which no standard therapy exists
- •History of receiving five or fewer prior chemotherapy-containing regimens for EOC, PPC, or FTC (including primary therapy)
排除标准
- •Prior treatment with chemotherapy or experimental anti-cancer agents within 4 weeks prior to Day 1
- •Prior treatment with oregovomab (OvaRex(R)) or abagovomab
- •History or clinical evidence of central nervous system or brain metastases
- •Grade ≥ 2 peripheral neuropathy
- •History of severe allergic or anaphylactic reactions to human, humanized, chimeric, or murine monoclonal antibodies
- •History of clinically symptomatic liver disease, including viral or other hepatitis, history of or current alcoholism, or cirrhosis
- •Untreated or persistent/recurrent malignancy (other than EOC, PPC, or FTC)
结局指标
主要结局
Incidence and nature of dose-limiting toxicities (DLTs)
时间窗: Length of study
次要结局
- Incidence, nature, and severity of adverse events(Length of study)
- Incidence of anti-D4064A antibodies(Length of study)
- Changes in vital signs and clinical laboratory results(Length of study)
研究者
研究点 (3)
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