NCT00140478已完成2 期
A Phase II Study of Mifepristone (RU-486) in Androgen Independent Prostate Cancer With Correlative Assessment of Androgen Receptor Co-Repressor Proteins
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 8
- 主要终点
- To determine the therapeutic efficacy of mifepristone in patients with androgen independent prostate cancer
研究概览
简要总结
The purpose of this study is to determine the effects (good and bad) that mifepristone has on patients with androgen independent prostate cancer.
详细描述
Patients will receive mifepristone, 200mg orally once a day. One treatment cycle is 28 days long. Patients will remain on treatment unless their cancer gets worse or they develop intolerable side effects.
At the end of each cycle a physical examination, routine blood tests, and hormone levels will be performed.
After every 3 cycles, one or more of the following will be performed: bone scan, chest x-ray, CT scan or MRI.
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
- •Histologic documentation of adenocarcinoma of the prostate
- •Bone metastasis(es) by bone scan or cat scan
- •Clinical, biochemical, or radiographic progression after primary androgen ablation with either orchiectomy or gonadotropin releasing hormone analog therapy.
- •One prior chemotherapy treatment is allowed.
- •> 3 weeks since major surgery
- •> 4 weeks since radiotherapy
- •> 8 weeks since prior strontium-89 or samarium 153
- •ECOG performance status 0 or 1
- •Absolute neutrophil count (ANC) > 1,500/ul
- •Platelets > 100,000/ul
- •Bilirubin < 1.5 x upper limit of normal (ULN)
- •AST or ALT < 3 x ULN
- •Creatinine < 1.5 x ULN
- •Electrolytes within 10% of normal range
- •Serum testosterone < 50ng/dL
- •Prostate-specific antigen (PSA) > 5.0ng/ml
排除标准
- •Concomitant therapy with corticosteroids
- •Chemotherapy within 28 days
- •Currently active second malignancy other than non-melanoma skin cancer
- •Baseline adrenal insufficiency requiring long-term steroids
结局指标
主要结局
To determine the therapeutic efficacy of mifepristone in patients with androgen independent prostate cancer
时间窗: 2 years
次要结局
- To determine the duration of response, time to disease progression and safety of mifepristone in patients with androgen independent prostate cancer
研究者
研究点 (8)
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