NCT00083928已完成2 期
A Phase 2 Randomized, Double-Blind Trial of the Clinical Activity and Safety of Å6 in Patients With Asymptomatic CA125 Progression of Epithelial Ovarian Cancer After First-Line Chemotherapy
Ångstrom Pharmaceuticals48 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2004年5月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 48
研究概览
简要总结
The purpose of this study is to determine whether injections of Å6 are effective in treating ovarian cancer patients who have completed first-line therapy and currently have no detectable cancer but have experienced a doubling of CA 125 levels.
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
- Double
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
- •Females ≥18 years of age
- •Histologically or cytologically documented primary epithelial ovarian carcinoma, cancer of the Fallopian tube, or primary peritoneal carcinoma
- •Completion of first-line chemotherapy
- •Clinical remission as a result of chemotherapy
- •History of normal CA125 level after initial course of therapy
- •CA125 serum level has shown 2 consecutive rises based on 3 consecutive samples which are mutually >= 28 days apart, provided that:
- •the 3rd sample is above the institution's ULN, and
- •the 3rd sample is confirmed by a 4th sample which is likewise higher than the 2nd sample value and is above the institution's ULN
- •No clinically evident disease progression, as assessed by history, physical examination, computed tomographic (CT) scan, or magnetic resonance imaging (MRI)
- •ECOG Performance Status of 0 or 1
- •No clinically significantly abnormal clinical laboratory tests or concomitant illnesses
- •Ability and willingness to self-administer subcutaneous injections
- •Although pregnancy is extremely unlikely in this patient population because of the disease and prior treatment, patients who have the potential to become pregnant must have a negative pregnancy test and must agree to practice an effective method of contraception throughout the trial.
排除标准
- •Persistent adverse events due to agents administered more than 4 weeks earlier
- •More than 1 course of previous chemotherapy for the qualifying cancer
- •Disease requiring chemotherapy or radiotherapy
- •Recent history of active infection, gastrointestinal bleeding, thromboembolic disorders, or anticoagulation
研究者
研究点 (48)
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