NCT00074867已完成2 期
A Clinical Efficacy Study Of An Oral Tyrosine Kinase Inhibitor Of VEGFR-2 To Treat Recurrent Or Persistent Small-Volume Epithelial Ovarian Cancer, Primary Peritoneal Serous Cancer, Or Fallopian Tube Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 29
- 试验地点
- 10
- 主要终点
- At the completion of Stage 1 of the study, it did not meet the objective response criteria to proceed to Stage 2 of the trial.
研究概览
简要总结
The purpose of this study is to determine whether CP-547,632, an oral VEGFR-2 tyrosine kinase inhibitor is effective in the treatment of epithelial ovarian cancer, primary peritoneal serous cancer, or fallopian tube cancer for patients who have failed first line platinum-based therapy and have a persistent rising CA-125.
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
- •Histologically proven epithelial ovarian cancer, primary peritoneal serous cancer, or fallopian tube cancerRecurrent or persistent elevated CA-
- •For the purpose of this study, elevated CA-125 is defined as a value of ≥40 U/ml on two separate consecutive determinations made ≥1 week apart.
- •CA-125 values obtained within 4 weeks of abdominal surgery should not be taken into account.
- •No definitive disease or clinical and findings of small volume disease (£1cm by spiral CT or £2cm by conventional CT or clinical exam).
排除标准
- •No prior exposure to mouse antibodies or prior VEGF or VEGF receptor targeted treatment or other anti-angiogenic-directed, anti-cancer treatment including thalidomide.
- •No prior consolidation therapy with cytotoxic agents for ovarian cancer.
- •Continuation of hormone replacement therapy is permitted.
- •No requirement for concomitant anticoagulant therapy.
- •Administration of low dose anticoagulants for maintenance of central venous access is permitted.No chronic oral or intravenous steroid use.
结局指标
主要结局
At the completion of Stage 1 of the study, it did not meet the objective response criteria to proceed to Stage 2 of the trial.
次要结局
- Given the outcome of the primary objective, analysis of secondary objectives were not formalized.
研究者
研究点 (10)
Loading locations...
相似试验
已完成
1 期
A Clinical Efficacy Study Of An Oral Tyrosine Kinase Inhibitor Of VEGFR-2 Given In Combination With ChemotherapyLung NeoplasmsNCT00074854Pfizer87
已完成
3 期
Paclitaxel With / Without GW572016 (Lapatinib) As First Line Therapy For Women With Advanced Or Metastatic Breast CancerNeoplasms, BreastNCT00075270GlaxoSmithKline580
终止
1 期
Trial of PTK787/ZK 222584 Plus PaclitaxelMetastatic Non-hematologic MalignanciesNCT00358163Dana-Farber Cancer Institute7
已完成
2 期
Efficacy and Safety Study of R935788 Tablets to Treat Rheumatoid ArthritisRheumatoid ArthritisNCT00665925Rigel Pharmaceuticals457
已完成
2 期
Efficacy and Safety Study of R935788 Tablets to Treat Rheumatoid Arthritis (Taski-3)Rheumatoid ArthritisNCT00665626Rigel Pharmaceuticals219