A Phase 1b Study of Abemaciclib Plus Darolutamide in Men With Metastatic Castration-Resistant Prostate Cancer
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 13
- 主要终点
- Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
研究概览
简要总结
The main purpose of this study is to learn more about the safety and tolerability of abemaciclib when given in combination with darolutamide to participants with prostate cancer that has spread after initial treatment. Participation may last up to 32 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Histologically confirmed adenocarcinoma of the prostate.
- •Metastatic castration-resistant prostate cancer evidenced by:
- •Prostate-specific antigen (PSA) or radiographic progression despite castrate levels of testosterone
- •At least 1 bone metastasis on bone scan and/or 1 soft tissue metastasis on computed tomography/magnetic resonance imaging (CT/MRI)
- •Participants who have not undergone bilateral orchiectomy must continue luteinizing-hormone-releasing hormone (LHRH) agonists/antagonists throughout the study.
- •Have adequate organ function.
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1.
排除标准
- •Prior treatment with cyclin-dependent kinase 4 and 6 (CDK4 and CDK6) inhibitors or darolutamide.
- •Prior systemic therapy for metastatic castration-resistant prostate cancer(mCRPC) with cytotoxic chemotherapy, PARP inhibitors, novel hormonal agents (NHAs) (enzalutamide, apalutamide, and abiraterone), and radiopharmaceuticals.
- •Serious preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study.
- •Clinically significant heart disease as evidenced by myocardial infarction, arterial thrombotic events, severe or unstable angina, or congestive heart failure (New York Heart Association Class III or IV) within 6 months of assignment to treatment.
研究组 & 干预措施
Abemaciclib + Darolutamide
Abemaciclib plus (+) darolutamide. Participants who have not undergone bilateral orchiectomy are required to continue background androgen deprivation therapy (ADT) with a luteinizing hormone-releasing hormone (LHRH) agonist/antagonist throughout the study.
干预措施: LHRH agonist/antagonist (Drug)
Abemaciclib + Darolutamide
Abemaciclib plus (+) darolutamide. Participants who have not undergone bilateral orchiectomy are required to continue background androgen deprivation therapy (ADT) with a luteinizing hormone-releasing hormone (LHRH) agonist/antagonist throughout the study.
干预措施: Darolutamide (Drug)
Abemaciclib + Darolutamide
Abemaciclib plus (+) darolutamide. Participants who have not undergone bilateral orchiectomy are required to continue background androgen deprivation therapy (ADT) with a luteinizing hormone-releasing hormone (LHRH) agonist/antagonist throughout the study.
干预措施: Abemaciclib (Drug)
结局指标
主要结局
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
时间窗: Date of first dose to study completion (approximately 32 months)
Administration Number of Participants with One or More SAEs Considered by the Investigator to be Related to Study Drug Administration
次要结局
- Objective Response Rate (ORR): Percentage of Participants with Soft Tissue Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR)(Date of first dose to radiographic disease progression or death from any cause (approximately 32 months))
- Prostate Specific Antigen (PSA) Response Rate (PSA-RR): Percentage of Participants with a PSA Decrease of at Least 50% from Baseline(Date of first dose to confirmed PSA progression (approximately 32 months))
- Pharmacokinetics (PK): Mean Concentrations of Darolutamide and its Active Metabolite(Cycle 1 Day 1 until Cycle 2 Day 1 (Cycle = 28 days))
- Pharmacokinetics (PK): Mean Concentrations of Abemaciclib and its Active Metabolite(s)(Cycle 1 Day 1 until Cycle 2 Day 1 (Cycle = 28 days))
- Time to Prostate Specific Antigen (PSA) Progression(Date of first dose to the first observation of PSA progression (approximately 32 months))
- Radiographic Progression-Free Survival (rPFS) Assessed by Investigator rPFS Assessed by Investigator(Date of first dose to radiographic disease progression or death from any cause (approximately 32 months))
- Duration of Response (DoR)(Date of first documented CR or PR to radiographic disease progression or death from any cause (approximately 32 months))