A Phase 2, Randomized, Open-label, Parallel Group Study to Evaluate the Safety and Efficacy of the Oral GnRH Antagonist TAK-385, Together With a Leuprorelin Observational Cohort, in Patients With Prostate Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 136
- 主要终点
- Percentage of Participants With Effective Castration Rate Over 24 Weeks
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of TAK 385 for achieving and maintaining testosterone suppression (<50 ng/dL).
详细描述
The drug being tested in this study is called relugolix (TAK-385). Relugolix is being tested to treat people who have prostate cancer. This study will look at achieving and maintaining testosterone suppression (<50 ng/dL).
The study enrolled 136 patients. Participants were randomly assigned (by chance, like flipping a coin) to one of the three treatment groups-which remained undisclosed to the patient and study doctor during the study (unless there was an urgent medical need):
- Relugolix 80 mg
- Relugolix 120 mg
- Leuprorelin 22.5 mg
Relugolix was administered starting with a 320 mg (loading dose), followed by relugolix 80 mg or 120 mg tablets, for 48 weeks plus an optional 48-week extension at the investigator's discretion. Patients randomized to leuprorelin were administered 22.5 mg subcutaneously on Day 1 and every 12 weeks for 4 injections.
This multicenter trial was conducted in the United States and Canada. The overall time to participate in this study was 114.4 weeks. Participants made multiple visits to the clinic and at 12 weeks after last dose of study drug for a follow-up assessment.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Relugolix 80 mg
Relugolix 320 mg (loading dose), tablets, orally, on Day 1 followed by relugolix 80 mg, tablets, orally, once daily for 48 weeks plus an optional 48 week extension at the investigator's discretion.
干预措施: Relugolix (Drug)
Relugolix 120 mg
Relugolix 320 mg (loading dose), tablets, orally, on Day 1 followed by relugolix 120 mg, tablets, orally, once daily for 48 weeks plus an optional 48 week extension at the investigator's discretion.
干预措施: Relugolix (Drug)
Leuprorelin 22.5 mg
Leuprorelin 22.5 mg, subcutaneous, injection on Day 1 and every 12 Weeks for up to 4 injections (48 weeks).
干预措施: Leuprorelin (Drug)
结局指标
主要结局
Percentage of Participants With Effective Castration Rate Over 24 Weeks
时间窗: Day 1 of Week 5 to Day 1 of Week 25
Effective Castration rate is defined as the observed percentage of participants who have testosterone concentrations less than (\<) 50 nanogram per deciliter (ng/dL) (1.73 nanomole per liter \[nmol/L\]) at all scheduled visits beginning after 4 weeks of treatment.
次要结局
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Vital Signs(From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks)
- Number of Participants With TEAES Related to Clinical Laboratory Test Results(From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks)
- Number of Participants With TEAEs Related to Physical Examination(From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks)
- Number of Participants With TEAEs Related to 12-lead Electrocardiogram (ECG) Findings(From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks)
- Percentage of Participants With Prostate-Specific Antigen (PSA) Response of ≥ 50% and ≥ 90% Reduction at 4 Weeks(Week 5, Day 1)
- Serum Prostate-Specific Antigen Concentration at the End of Weeks 12 and 24(Day 1 of Weeks 13 and 25)
- Time to Achieve Testosterone Concentrations < 50 ng/dL and < 20 ng/dL(During Weeks 1 to 24)
- TAK-385 Plasma Concentrations(Day 1 of Weeks 1, 2, 3, 5, 9, 13, 17, 25, 37, 49 pre-dose; Day 4 of Week 1 pre-dose; Day 1 of Weeks 5, 13, 2 hrs post-dose)
- Serum Follicle Stimulating Hormone (FSH) Concentrations(Day 1 of Weeks 2, 5, 13, 25, 49, EOT (106.4 Weeks), Follow-up (110.4 Weeks) and End of Study (114.4 Weeks))
- Percent Change From Baseline of Aging Male Survey (AMS) Total Score(Baseline and Day 1 of Weeks 5,13, 25, 37 and 49, EOT (106.4 Weeks), Follow-up (110.4 Weeks) and End of Study (114.4 Weeks))
- Number of Participants Reporting One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)(From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks)
- Prostate-Specific Antigen Nadir(During Weeks 1 to 24)
- Change From Baseline in EORTC QLQ-C30(Day 1 of Weeks 5, 13, 25, 37, 49, 73, 97, EOT (106.4 Weeks), Follow-up (110.4 Weeks) and End of Study (114.4 Weeks))
- Serum Luteinizing Hormone (LH) Concentrations(Baseline and Day 4 of Week 1, Day 1 of Weeks 2, 3, 5,13, 25 and 49, End of Treatment (EOT - 106.4 Weeks), Follow-up (110.4 Weeks) and End of Study (114.4 Weeks))
- Serum Sex Hormone-binding Globulin (SHBG) Concentrations(Day 1 of Weeks 2, 5, 13, 25, 49, EOT (106.4 Weeks), Follow-up (110.4 Weeks) and End of Study (114.4 Weeks))
- Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score(Baseline and Day 1 of Weeks 5,13, 25, 37 and 49, EOT (106.4 Weeks), Follow-up (110.4 Weeks) and End of Study (114.4 Weeks))