NCT00959959已完成1 期
ARMOR1: Phase 1, Open Label, Dose Escalation Trial of TOK-001 for the Treatment of Chemotherapy Naive Castration Resistant Prostate Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 8
- 主要终点
- Phase 1: Incidence of adverse events
研究概览
简要总结
The purpose of this study is to determine whether TOK-001 is safe and shows biological effect in the treatment of castration resistant prostate cancer (CRPC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Signed informed consent form
- •Confirmed cancer of the prostate
- •Progressing disease in spite of androgen ablation therapy
- •Able to swallow multiple capsules
排除标准
- •Participation in another clinical trial < 4 weeks prior to enrollment
- •Metastatic disease with one or more of the following:
- •Liver involvement
- •Bone pain associated with confirmed evidence of metastases
- •Non-hepatic visceral involvement
- •The following medications:
- •Prior treatment with MDV3100, abiraterone, Provenge or TAK700
- •Prior treatment with ketoconazole
- •Prior treatment with chemotherapy
- •Prior radiation therapy completed ≤ 4 weeks prior to enrollment
- •The following medical conditions:
- •Active angina pectoris
- •History of Hepatitis B or Hepatitis C
- •Known HIV infection
- •Ongoing hypertension
- •Note: There are additional inclusion and exclusion criteria. The clinical site center will determine if you are eligible. If you are not eligible for the trial, site staff will detail the reasons to you.
研究组 & 干预措施
650 mg TOK-001
Experimental
干预措施: TOK-001 (Drug)
1300 mg TOK-001
Experimental
干预措施: TOK-001 (Drug)
1950 mg TOK-001
Experimental
干预措施: TOK-001 (Drug)
975 mg TOK-001
Experimental
干预措施: TOK-001 (Drug)
975 mg TOK-001, supplement
Experimental
干预措施: TOK-001 (Drug)
1950 mg TOK-001, split dose
Experimental
干预措施: TOK-001 (Drug)
2600 mg TOK-001
Experimental
干预措施: TOK-001 (Drug)
2600 mg TOK-001, split dose
Experimental
干预措施: TOK-001 (Drug)
结局指标
主要结局
Phase 1: Incidence of adverse events
时间窗: 3 months
Safety will be assessed by incidence of AEs and change from baseline in the following additional safety parameters: clinical laboratory assessments, physical examination, vital signs, and 12 lead electrocardiograms (ECGs)
次要结局
- Efficacy Measures(3 months)
研究者
研究点 (8)
Loading locations...
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