A Phase I Dose Escalating Study Evaluating the Pharmacodynamic Profile and Safety of BN83495 in Patients With Prostate Cancer With Evidence of Disease Progression While on Androgen Ablative Therapy
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Ipsen
- 入组人数
- 17
- 试验地点
- 3
- 主要终点
- Absolute and percentage change in levels of hormones from baseline to D28/29 at 6 timepoints
研究概览
简要总结
The purpose of the study is to evaluate the pharmacodynamic profile and safety of BN83495 in patients with prostate cancer with disease progression while on androgen ablative therapy
详细描述
Evaluate the PD profile of BN83495 after 28 days of daily oral administration in patients with locally advanced or metastatic prostate cancer on androgen ablative therapy and with rising prostatic specific antigen
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
- •Confirmed and locally advanced or metastatic prostate cancer with rising prostate-specific antigen (PSA), while on androgen ablative therapy.
- •Demonstrated PSA "biochemical failure".
- •Adequate bone marrow and hepatic function
排除标准
- •Luteinizing Hormone-Releasing Hormone analogue treatment and treated with more than one additional second line of endocrine therapy
- •Prior treatment with ketoconazole
- •Prior chemotherapy for hormone refractory prostate cancer
- •Pre-existing cardiac failure and/or clinically significant abnormal ECG or Echo
研究组 & 干预措施
Cohort 1
6 patients have been enrolled, the cohort has been completed.
干预措施: BN83495 (Cohort 1) (Drug)
Cohort 2
6 patients have been enrolled in cohort 2, the cohort has been completed.
干预措施: BN83495 (Cohort 2) (Drug)
Cohort 3
5 patients have been enrolled in cohort 3. The cohort was closed after the 5th patient enrolled.
干预措施: BN83495 (Cohort 3) (Drug)
结局指标
主要结局
Absolute and percentage change in levels of hormones from baseline to D28/29 at 6 timepoints
时间窗: 28 days
次要结局
- Pharmacokinetic assessments/Pharmacodynamic assessments(Pre-determined timepoints from baseline to day 28/29)
- Tolerance (Physical Exam, ECOG Performance Status, Electrocardiogram, biochemistry/haematology, Urinalysis, Adverse Events, Concomitant Medications, disease progression)(Each visit through day 28/29)