A Phase II Study of SU011248 for Maintenance Therapy in Hormone Refractory Prostate Cancer After First Line Chemotherapy
试验速览
- 阶段
- 2 期
- 入组人数
- 30
- 试验地点
- 8
- 主要终点
- Progression Free Survival
研究概览
简要总结
The major goal is to determine whether the experimental agent has clinically promising activity that would merit progression to a formal phase III trial.
Patients with hormone refractory prostate cancer after docetaxel chemotherapy have limited treatment options and no systemic treatment has been proven to be effective. Because of its action, safety and simple administration SU011248 has potential for effectiveness in this disease setting. Promising activity in this study would provide the necessary proof-of-principle for a larger confirmatory study in this population, and potentially in earlier stages of this common disease.
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
- Male
- 接受健康志愿者
- 否
入选标准
- •Histological or cytological diagnosis of adenocarcinoma of the prostate
- •Metastatic or locally recurrent disease not curable with standard therapy
- •ECOG performance status 0, 1 or 2
- •Prior single agent docetaxel or docetaxel combination chemotherapy with a documented PSA or imaging response, and no objective evidence of disease progression at study enrolment
排除标准
- •Patients with a history of other invasive cancer, except adequately treated non
- •melanoma skin cancer.
- •Patients with known brain metastases.
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to SU
- •Other serious intercurrent illness or medical condition that might be aggravated by protocol treatment.
结局指标
主要结局
Progression Free Survival
时间窗: 180 days without evidence of disease progression would be considered clinically worthy of further investigation
次要结局
- -PSA Response -Toxicity(The secondary endpoint of PSA response will also be documented. PSA response is defined as a ≥50% fall in PSA (minimum of 5 µg/L) from baseline maintained for > 3 weeks and without evidence of disease progression otherwise.)
研究者
Rachel Syme
Dr. Bernie Eigl
Alberta Health services