CTIS2024-511038-11-00进行中（未招募）1 期
A Phase 2, randomized, open-label, dose-finding study of Debio 4228, an extended-release formulation of gonadotropin-releasing hormone antagonist in participants with locally advanced/metastatic prostate cancer - Debio 4228-201
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- Male
入选标准
- •Participant with histologically confirmed locally advanced/metastatic prostate cancer, Participant judged by the Study Investigator to be candidate for continuous ADT, Baseline morning serum testosterone levels >150 ng/dL at screening visit, Age =18 years, Eastern Cooperative Oncology Group (ECOG) performance status of 0-2, Life expectancy of at least 6 months, Adequate bone marrow, hepatic, and renal function at the screening visit, Other protocol and subprotocol defined criteria apply.
排除标准
- •Previous ADT (neoadjuvant or adjuvant hormonal therapy) for =6 months duration and <6 months treatment-free interval before start of screening, Indication for androgen deprivation combination therapy, History of bilateral orchiectomy, adrenalectomy, or hypophysectomy, Received chemotherapy or cryotherapy within 8 weeks prior to the start of screening for the treatment of prostate cancer, Abnormal cardiovascular function or diabetes, Use of exogenous testosterone within 6 months before the start of screening, Major surgery within 4 weeks before the start of screening, Cancer disease within the last two years except for prostate cancer and some skin cancers, Other protocol and subprotocol-defined criteria apply.
研究者
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