NCT04428788已完成1 期
A Phase 1, Multi-center, Open-label, Dose Finding Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Cc-94676 in Subjects With Metastatic Castration-resistant Prostate Cancer
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Celgene
- 入组人数
- 131
- 试验地点
- 19
- 主要终点
- Non-tolerated dose (NTD)
研究概览
简要总结
The purpose of this study is to assess the safety, tolerability and preliminary efficacy of CC-94676 in men with progressive metastatic castration resistant prostate cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 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
- •Must have histologically or cytologically confirmed adenocarcinoma of the prostate
- •Progressed on androgen deprivation therapy (ADT) and at least one prior secondary hormonal therapy approved for castration-resistant prostate cancer (CRPC)
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
排除标准
- •Prior treatment with an androgen receptor (AR) degrader
- •Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 1 year prior to the first dose of IP
- •Clinically significant venous thromboembolism within 3 months prior to the first dose of IP
- •Any significant medical condition, such as uncontrolled infection, laboratory abnormality, or psychiatric illness
- •Other protocol-defined inclusion/exclusion criteria apply
研究组 & 干预措施
Administration of CC-94676, CC1083611, and CC1083610
Experimental
干预措施: CC-94676 (Drug)
Administration of CC-94676, CC1083611, and CC1083610
Experimental
干预措施: CC1083611 (Drug)
Administration of CC-94676, CC1083611, and CC1083610
Experimental
干预措施: CC1083610 (Drug)
结局指标
主要结局
Non-tolerated dose (NTD)
时间窗: Up to 35 days
Maximum tolerated dose (MTD)
时间窗: Up to 35 days
Number of participants with adverse events (AEs) evaluated using the NCI CTCAE v5.0 criteria
时间窗: From the time of consent at screening until 28 days after thesubject discontinues study treatment.
Dose-limiting toxicity (DLT)
时间窗: Up to 35 days
次要结局
- Overall survival (OS)(Up to approximately 4 years)
- Objective soft tissue response defined by complete response (CR) or partial response (PR) per Prostate Cancer Clinical Trials Working Group 3 (PCWG3)(Up to approximately 4 years)
- Proportion of participants alive and not progressed at 6 months(Up to 6 months after treatment is discontinued)
- Confirmed Prostate Specific Antigen (PSA) decline of ≥ 50% from baseline (PSA50)(Up to approximately 4 years)
- PSA Progression Free Survival (PFS)(Up to approximately 4 years)
- Pharmacokinetics - Area under the plasma concentration time curve (AUC)(Up to 35 days)
- Duration of response (DOR)(Up to approximately 4 years)
- Radiographic progression free survival (rPFS)(Up to approximately 4 years)
- Pharmacokinetics - Maximum plasma concentration (Cmax)(Up to 35 days)
- Pharmacokinetics - Time to Cmax (Tmax)(Up to 35 days)
- Overall Survival (OS) rate summarized using the Kaplan-Meier method for the treated population(Up to approximately 4 years)
研究者
研究点 (19)
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