A Multicenter Phase 4, Open-label, Single-arm, Safety and Efficacy Study of Enzalutamide in Indian Patients With Progressive Metastatic Castration-Resistant Prostate Cancer (mCRPC) Previously Treated With Docetaxel-Based Chemotherapy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 8
- 主要终点
- Number of Participants With Treatment- Emergent Adverse Events (TEAEs)
研究概览
简要总结
The purpose of this study was to evaluate the safety and tolerability of enzalutamide in Indian patients with progressive mCRPC previously treated with docetaxel-based chemotherapy. This study also evaluated the effect of enzalutamide on prostate-specific antigen (PSA).
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
- •Subject is diagnosed with histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation, signet cell or small cell histology.
- •Subject with established diagnosis of metastatic castration-resistant prostate carcinoma.
- •Subject is being newly initiated on Xtandi treatment (Enzalutamide).
- •Subject has an estimated life expectancy of ≥ 6 months.
- •Subject agrees not to participate in another interventional study while participating in the present study.
排除标准
- •Subject who is not eligible to receive Xtandi as per the locally approved prescribing information.
- •Subject participating or planning to participate in any interventional drug trial during the course of this trial.
- •Subject has received investigational study within 28 days or 5 half-lives, whichever is longer, prior to screening.
- •Subject has any condition which makes the subject unsuitable for study participation.
研究组 & 干预措施
Enzalutamide
Participants with progressive mCRPC who had previously been treated with docetaxel-based chemotherapy received 160 milligrams (mg) (4 capsules of 40 mg) enzalutamide orally, once daily until disease progression, unacceptable toxicity or any other discontinuation criteria were met.
干预措施: Enzalutamide (Drug)
Enzalutamide
Participants with progressive mCRPC who had previously been treated with docetaxel-based chemotherapy received 160 milligrams (mg) (4 capsules of 40 mg) enzalutamide orally, once daily until disease progression, unacceptable toxicity or any other discontinuation criteria were met.
干预措施: Androgen deprivation therapy (ADT) (Drug)
结局指标
主要结局
Number of Participants With Treatment- Emergent Adverse Events (TEAEs)
时间窗: From first dose of study drug until 30 days after last dose (Up to 1899 days)
An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE could therefore be any unfavorable \& unintended sign (including an abnormal laboratory finding \[e.g. hematology, clinical chemistry, or urinalysis or other safety assessment e.g., ECGs, radiographic scans, vital signs measurements, physical examination\]), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. TEAE was defined as an adverse event observed after starting administration of the study drug.
次要结局
- Percentage of Participants With Confirmed Prostate-specific Antigen (PSA) Response(Baseline (Day 1); Days 29, 57, 85, 169 and then every 84 days until 30 days after the last dose (up to Day 1899))