NCT01193257已完成3 期
A Phase 3, Randomized, Double-Blind, Multicenter Trial Comparing Orteronel (TAK-700) Plus Prednisone With Placebo Plus Prednisone in Patients With Metastatic Castration-Resistant Prostate Cancer That Has Progressed During or Following Docetaxel-based Therapy.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,099
- 主要终点
- Overall Survival
研究概览
简要总结
This is a randomized, double-blind, multicenter, phase 3 study evaluating orteronel plus prednisone compared with placebo plus prednisone in men with metastatic, castration-resistant prostate cancer (mCRPC) that has progressed following Docetaxel-based therapy
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
- Double (Participant, Investigator)
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
- •Each participant must meet all of the following inclusion criteria:
- •Voluntary written consent
- •Male 18 years or older
- •Histologically or cytologically confirmed diagnosis of prostate adenocarcinoma
- •Radiograph-documented metastatic disease
- •Progressive disease
- •Prior surgical castration or concurrent use of an agent for medical castration
- •Progressive disease during or following 1 or 2 regimens of cytotoxic chemotherapy, 1 of which must have included docetaxel. Must have received greater than or equal to (>=) 360 milligram per square meter (mg/m^2) of docetaxel within a 6-month period. Participants who were clearly intolerant to docetaxel or develop progressive disease before receiving >= 360 mg/m^2 are also eligible if they have received at least 225 mg/m^2 of docetaxel within a 6-month period and meet the other study entry criteria.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- •Even if surgically sterilized, participants must practice effective barrier contraception during the entire study treatment period and for 4 months after the last dose of study drug, OR Abstain from heterosexual intercourse
- •Screening laboratory values as specified in protocol
- •Stable medical condition
- •Life expectancy of 6 months or more
- •Participants who have had up to 2 prior chemotherapy treatments are eligible to participate
排除标准
- •Participants meeting any of the following exclusion criteria are not to be enrolled in the study:
- •Known hypersensitivity to orteronel, prednisone or gonadotropin-releasing hormone (GnRH) analogue
- •Received prior therapy with orteronel, aminoglutethimide, ketoconazole or abiraterone
- •Any other therapies for prostate cancer, except for GnRH analogue therapy, must be discontinued 2 weeks before the first dose of study drug
- •Radioisotope therapy or external beam radiation therapy within 4 weeks of first dose of study drug
- •Documented central nervous system metastases
- •Treatment with any investigational compound within 30 days prior to first dose of study drug (Participants who are in long-term follow-up following active treatment in other trials are eligible)
- •Diagnosis or treatment of another malignancy within 2 years preceding first dose of study drug except nonmelanoma skin cancer or in situ malignancy completely resected
- •Uncontrolled cardiovascular condition as specified in study protocol
- •Known history of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C
- •Unwilling or unable to comply with protocol
- •Known gastrointestinal disease or procedure that could interfere with oral absorption or tolerance of orteronel
- •Uncontrolled nausea, vomiting, or diarrhea despite appropriate medical therapy
- •Prostate cancer confined to just the prostrate bed or immediate adjacent tissue
研究组 & 干预措施
Orteronel + prednisone
Experimental
干预措施: Orteronel (Drug)
Orteronel + prednisone
Experimental
干预措施: Prednisone (Drug)
Placebo + prednisone
Placebo Comparator
干预措施: Prednisone (Drug)
Placebo + prednisone
Placebo Comparator
干预措施: Orteronel Placebo (Drug)
结局指标
主要结局
Overall Survival
时间窗: Baseline until death (approximately up to 4.5 years)
Overall survival was calculated from the date of participant randomization to the date of participant death due to any cause. Participants without documentation of death at time of the analysis were censored as of the date the participant was last known to be alive, or the data cutoff date, whichever was earlier.
次要结局
- Radiographic Progression-free Survival (rPFS)(Baseline until disease progression or death, whichever occurred first (approximately up to 4.5 years))
- Percentage of Participants With Pain Response at Week 12(Week 12)
- Number of Participants With TEAEs Related to Weight(Baseline up to 30 days after last dose of study drug (Cycle 59 Day 58))
- Percentage of Participants Achieving PSA50 Response at Any Time During the Study(Cycle: 4, 7, 10, 13, 16, 19, 22, and 25)
- Percentage of Participants Achieving PSA90 Response at Any Time During the Study(Cycle: 7, 10, 13, 16, 19, 22, and 25)
- Number of Participants With Abnormal Physical Examination Findings(Baseline up to 30 days after last dose of study drug (Cycle 59 Day 58))
- Best PSA Response at Any Time During the Study(Cycle: 4, 7, 10, 13, 16, 19, 22, and 25)
- Percentage of Participants With Objective Response(Baseline until disease progression or death, whichever occurred first (approximately up to 4.5 years))
- Percentage of Participants Achieving 50 Percent Reduction From Baseline in Prostate Specific Antigen (PSA50 Response) at Week 12(Week 12)
- Number of Participants With TEAEs Related to Vital Signs(Baseline up to 30 days after last dose of study drug (Cycle 59 Day 58))
- Time to PSA Progression(Baseline until the final on treatment assessment or until end of short term follow-up following discontinuation of treatment, whichever occurred later (approximately up to 4.5 years))
- Time to Pain Response(Baseline until disease progression or death, whichever occurred first (approximately up to 4.5 years))
- Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)(Baseline up to 30 days after last dose of study drug (Cycle 59 Day 58))
- Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Findings(Cycle 59 Day 58)
- Number of Participants With TEAEs Categorized Into Investigations Related to Chemistry, Hematology or Steroid Hormone Panel(Baseline up to 30 days after last dose of study drug (Cycle 59 Day 58))
- Percentage of Participants Achieving 90 Percent Reduction From Baseline in Prostate Specific Antigen (PSA90 Response) at Week 12(Week 12)
- Percentage of Participants With Health-related Quality of Life (HRQOL) Response at Week 12(Week 12)
- Number of Participants With Worst Change From Baseline in Eastern Co-operative Oncology Group (ECOG) Performance Status(Baseline up to End-of-treatment (EOT) (Cycle 59 Day 58))
- Number of Participants With Shifts From Baseline Between Favorable and Unfavorable Categories in Circulating Tumor Cell Count (CTC)(Baseline and EOT (Cycle 59 Day 58))
- Number of Participants With Best Pain Response(Baseline until disease progression or death, whichever occurred first (approximately up to 4.5 years))
- Time to Pain Progression(Baseline until EOT visit or until end of short term follow-up, whichever occurred later (approximately up to 4.5 years))
研究者
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