NCT00174863已完成2 期
Evaluation of Two Doses of SR31747A (75 mg and 125 mg) in Non-Metastatic Androgen-Independent Prostate Cancer. Randomized, Double-Blind, Placebo Controlled Phase II Study
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 232
- 试验地点
- 13
- 主要终点
- Time To Clinical Progression assessed by every 4 weeks clinical examination and every 12 weeks radiological examinations (Thoraco-abdominopelvic CT scan ; Bone scan ± centered Bone X-rays, MRI)
研究概览
简要总结
To evaluate the efficacy of SR31747 given at 75 or 125mg per day versus placebo in androgen prostate cancer patient without distant metastases with Time to Clinical progression as main objective and PSA parameters, Tumor response, survival , safety,Tumor-related symptoms deterioration Quality of Life, PK analysis as secondary objectives
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
- •Prior confirmed histological diagnosis of prostatic carcinoma.
- •Rising PSA while receiving hormonal therapy or after surgical castration defined as 2 sequential increases above a previous lowest reference value within the past 12 months; PSA must be at least 4ng/ml at the time of study entry.
- •No distant metastases as evidenced by bone scan (+ or - centered X-Ray or MRI), and spiral thoracoabdominopelvic CT scan.
- •Effective castration throughout the study. Any prior anti-androgen therapy should be stopped with documented continued elevation of PSA 4 weeks after the cessation of flutamide (6 weeks for bicalutamide).
- •Serum testosterone levels < 50ng/dL at the time of progression and throughout the study.
- •Age > or = to 18 years.
- •Extensive metabolizer by CYP2D6 genotyping.
- •Karnofsky Performance Status > or = to 70% and life expectancy > 6 months.
- •Adequate hematological, renal and liver function.
- •Signed written informed consent
排除标准
- •Poor metabolizers by CYP2D6 genotyping.
- •Prior palliative radiotherapy or any prior chemotherapy or experimental therapy.
- •More than one line of any prior anticancer treatment with estrogen (estrogen or estramustine) if discontinued at least 4 weeks before study entry.
- •Concomitant administration of biphosphonate or chronic corticosteroids.
- •Presence of progressive symptoms not adequately controlled with non opioid medications
- •Concomitant use of medications known to be cytochrome P450 2D6 inhibitors as listed in protocol appendice
- •Previous malignancies except if there has been a disease-free interval of at least 5 years and except curatively treated non-melanoma skin cancer
- •Other serious illness or medical condition, which would not permit the patient to be managed according to the protocol.
结局指标
主要结局
Time To Clinical Progression assessed by every 4 weeks clinical examination and every 12 weeks radiological examinations (Thoraco-abdominopelvic CT scan ; Bone scan ± centered Bone X-rays, MRI)
次要结局
- Every 12 weeks: radiological examinations (tumor response),
- Every 4 weeks: Clinical examination (safety, Tumor related symptoms deterioration), PSA level determination (PSA endpoints), EuroQoL instrument (Quality of Life), Laboratory tests (Hematology, Biochemistry), one PK sample
研究者
研究点 (13)
Loading locations...
相似试验
招募中
2 期
Efficacy and Safety of SR1375 in Adult Patients With CAPCommunity-acquired PneumoniaNCT06577558Shanghai SIMR Biotechnology Co., Ltd.240
已完成
2 期
Dose-effect of SSR180575 in Diabetic NeuropathyDiabetic NeuropathiesNCT00502515Sanofi309
已完成
2 期
Study of the Effect of SR57667B in Patients With Alzheimer's DiseaseAlzheimer DiseaseNCT00285025Sanofi500
已完成
2 期
A Trial of CS-747 (Prasugrel) Compared With Clopidogrel in Patients Undergoing Percutaneous Coronary Intervention (PCI)Cardiovascular DiseasesHeart DiseasesNCT00059215Eli Lilly and Company905
已完成
2 期
A 12-Week Placebo-Controlled Study to Investigate the Efficacy, Safety, and Tolerability of RO7017773 in Participants Aged 15-45 Years With Autism Spectrum Disorder (ASD)Autism Spectrum Disorder (ASD)NCT04299464Hoffmann-La Roche104