Phase 1/2a, Open-Label, Dose-Escalation and Safety Study of APC-100 [Pentamethylchromanol, 2,2,5,7,8-Pentamethyl-6] in Men With Advanced Prostate Cancer
试验速览
- 阶段
- 1 期
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Maximum Tolerated Dose (MTD) and recommended Phase 2a Dose
研究概览
简要总结
This study is a phase 1/2a, open label, dose escalation and safety study of APC-100 (2,2,5,7,8-Pentamethyl-6-chromanol) in men with advanced prostate cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Patients with histopathologically proven adenocarcinoma of the prostate
- •Patients must have progressive disease
- •Patients must have had prior treatment with bilateral orchiectomy or androgen deprivation therapy with an LHRH-blocker with evidence of treatment failure
排除标准
- •Patients treated with other secondary hormonal therapies
- •Patients with prior chemotherapy given for castrate-resistant prostate cancer
- •Patients with prior radiation therapy completed less than 4 weeks prior enrollment
- •Patients with prior investigational therapies within 4 weeks before treatment with APC-100
- •Evidence of active second malignancy
研究组 & 干预措施
APC-100
干预措施: APC-100 (Drug)
结局指标
主要结局
Maximum Tolerated Dose (MTD) and recommended Phase 2a Dose
时间窗: Within 12 weeks following treatment
Determination of the MTD based on documentation of dose-limiting toxicities (DLTs) and adverse events. Eighteen patients will be accrued for this part of the study. The MTD will be determined based on both the acute DLTs (within the first cycle of treatment) and late (within cycles 2 through 3) DLTs of APC-100. The establishment of a recommended phase 2a dose will be based on toxicity (DLTs within the first 28 days) and tolerability (DLTs within the first 12 weeks) of APC-100.
次要结局
- Assess number, types, and severity of toxicity and adverse events(12 weeks)
- Assess preliminary evidence of anti-tumor activity through PSA response(pre-study, Cycle 1: Day 1 (unless prestudy was performed within 7 days of study entry), Cycle 2: Day 1, End of Treatment)
- Plasma Pharmacokinetics (PK) profile of APC-100(Pre-Dose, Cycle 1:Day 1, Cycle 2:Day 2,Pre-Dose on Day 1 of each additional cycle)