A Phase 2 Open-label Extension Study to Assess the Safety of Continued Administration of MDV3100 in Subjects With Prostate Cancer Who Showed Benefit From Prior Exposure to MDV3100
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 7
- 主要终点
- Number of Participants With Adverse Events (AEs)
研究概览
简要总结
A study to assess the safety of continued administration of MDV3100 in subjects with Prostate Cancer who have already undergone treatment with MDV3100 and showed benefit.
详细描述
This was a multi-center extension study in participants with prostate cancer who have completed MDV3100 treatment study to assess the long-term safety of continued administration of MDV3100, when judged by the investigator to be in the best interest of the participant. For the study duration, all participants with castration-resistant prostate cancer (CRPC) maintained androgen deprivation with a Luteinizing Hormone Releasing Hormone (LHRH) agonist/antagonist unless they underwent bilateral orchiectomy. Participants were discontinued from study drug when the continued administration of study drug was deemed to be not in the participants' best interest by the investigator based on clinical assessment. Throughout the study, safety and tolerability were assessed by the recording of adverse events, monitoring of vital signs and physical examinations, safety laboratory evaluations, and 12-lead electrocardiograms (ECGs). Participants had a safety follow-up visit 30 days after their last dose of study drug. Participants that did not meet any of the discontinuation criteria were eligible to continue to receive treatment with enzalutamide in study 9785-CL-0123 [NCT02960022] upon approval and activation of the study at the participating institution. Participants who enrolled in study 9785-CL-0123 [NCT02960022] were not required to have a safety follow-up visit.
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
- •Has completed a prior study with MDV3100, can be enrolled in this extension study without any interruption in study drug
- •No new clinically significant abnormalities based upon physical examination, safety laboratory data, vital signs, ECG, and other clinical assessments noted from the last visit conducted during the subject's active MDV3100 study prior to initiation of this study
- •Male subjects and their female spouses/partners who are of childbearing potential must be using highly effective contraception1 consisting of two forms of birth control (one of which must be a barrier method) starting at Screening and continue throughout the study period and for 3 months after final study drug administration. Male subjects must not donate sperm starting at Screening and throughout the study period and for at least 3 months after final study drug administration. 1Highly effective contraception is defined as:
- •Established use of oral, injected or implanted hormonal methods of contraception.
- •Placement of an intrauterine device (IUD) or intrauterine system (IUS).
- •Barrier methods of contraception: Condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal form/gel/film/ cream/suppository
- •Subject agrees not to participate in another interventional study while on treatment
排除标准
- •Subject will be excluded from participation if any of the following apply:
- •Subject has a history of seizure or any condition that may predispose to seizure including, but not limited to underlying brain injury, stroke, primary brain tumours, brain metastases, or alcoholism.
- •Subject has a history of loss of consciousness or transient ischemic attack within 12 months prior to Day 1 of the completed preceding study.
- •Use of the following prohibited medication/therapies:
- •Concomitant medication that likely could cause clinically relevant drug-to-drug interactions with MDV
- •Other (than MDV3100) androgen-receptor (AR) antagonists (bicalutamide, flutamide, nilutamide).
- •Investigational therapy other than MDV3100 or investigational procedures of any kind.
研究组 & 干预措施
Enzalutamide
Participants received 160 mg enzalutamide orally once a day. Participants continued on treatment unless the dose was reduced or treatment was interrupted during the study.
干预措施: Enzalutamide (Drug)
结局指标
主要结局
Number of Participants With Adverse Events (AEs)
时间窗: From the date of the first dose of study drug to 30 days after last dose of study drug; the median duration of treatment was 392 days, and the maximum was 1926 days
An AE was defined as any untoward medical occurrence in a participant administered study drug or who underwent study procedures and did not necessarily have a causal relationship with treatment. An abnormality identified during a medical test was defined as an AE only if the abnormality induced clinical signs or symptoms, required active intervention, required interruption, or discontinuation of study medication, or was clinically significant in the opinion of the investigator. An AE was defined as serious if it resulted in any of the following outcomes: Death, Was life-threatening, Persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, Congenital anomaly, or birth defect, Inpatient hospitalization or prolongation of hospitalization, Other medically important event. Drug-related AEs were those assessed by the investigator as AEs whose relationship to the to the study drugs could not be ruled out.
次要结局
未报告次要终点