NCT04408924已完成2 期
CYCLONE 1: A Phase 2 Study of Abemaciclib in Metastatic Castration-Resistant Prostate Cancer Patients Previously Treated With a Novel Hormonal Agent and Taxane-based Chemotherapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 14
- 主要终点
- Percentage of Participants With Confirmed Objective Response (Objective Response Rate [ORR])
研究概览
简要总结
The study will evaluate how safe and effective abemaciclib is when given to participants whose metastatic prostate cancer progresses after they had received several previous treatments.
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
- •Participant must have metastatic prostate cancer for which castration (medical or surgical) is no longer effective (castration-resistant).
- •Participant must have disease spread to soft tissue that is measurable.
- •Participant must have documented evidence of progressive disease by PSA test or imaging.
- •Participant must have previously received at least one of the following treatment: abiraterone acetate, apalutamide, darolutamide or enzalutamide.
- •Participant must have previously received chemotherapy with docetaxel and cabazitaxel.
- •Participant must be willing and amenable to undergo a biopsy of tumor tissue (or able to provide adequate archived tumor tissue sample) and to provide blood for research.
- •Participant must have good physical functioning ability and adequate organ function.
排除标准
- •Participant must not have received more than 3 therapy regimens for metastatic castration-resistant prostate cancer (NOTE: GnRHa, first-generation antiandrogens (flutamide, nilutamide, or bicalutamide), diethylstilbestrol (DES) (or other estrogens), corticosteroids, ketoconazole, and bone loss-prevention will not count as systemic therapy regimens.
- •Participants must not have previously received abemaciclib or any cyclin-dependent kinase (CDK)4 and/or CDK6 inhibitors.
- •Participants must not have serious and/or uncontrolled preexisting medical condition(s) including but not limited to severe renal impairment, severe hepatic impairment, interstitial lung disease (ILD)/pneumonitis, severe dyspnea at rest or requiring oxygen therapy or other serious preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study.
- •Participants must not have, or suspected to have, brain metastasis.
- •Participants must not have untreated spinal cord compression, evidence of spinal metastases with risk of spinal compression or structurally unstable bone lesions suggesting impending fracture.
研究组 & 干预措施
200 milligram (mg) Abemaciclib Twice Daily
Experimental
Participants received 200 mg abemaciclib administered orally twice daily on a continuous dosing schedule (28-day cycle) until symptomatic and/or radiographic progression, unacceptable toxicity, or until another discontinuation criterion is met.
干预措施: Abemaciclib (Drug)
结局指标
主要结局
Percentage of Participants With Confirmed Objective Response (Objective Response Rate [ORR])
时间窗: From Date of First Dose until Objective Progression (Up To 12.8 Months)
ORR is defined as the percentage of participants with a confirmed complete response (CR) or confirmed partial response (PR) in soft tissue per response evaluation criteria in solid tumors (RECIST) version 1.1 and do not have concurrent bone progression per Prostate Cancer Clinical Trials Working Group 3 (PCWG3), as assessed by the investigator. ORR = (participants with confirmed CR and no bone progression) + (participants with confirmed PR and no bone progression) x 100 / all treated participants.
次要结局
- Time to Prostate-Specific Antigen (PSA) Progression(From Date of First Dose until Confirmed PSA Progression (Up To 12.8 Months))
- Radiographic Progression-Free Survival (rPFS)(From Date of First Dose until Objective Progression or Death from Any Cause (Up To 12.8 Months))
- Overall Survival (OS)(From Date of First Dose until Date of Death from Any Cause (Up To 28 Months))
- Duration of Response (DoR)(CR or PR to Disease Progression or Death Due to Any Cause (Up to 12 Months))
- Percentage of Participants Achieving CR, PR or Stable Disease (SD) (Disease Control Rate [DCR])(From Date of First Dose until Measured Progressive Disease or Death Due to Any Cause (Up To 12.8 Months))
- Percentage of Participants Who Achieved Prostate-Specific Antigen (PSA) Response (PSA Response Rate)(From Date of First Dose until Confirmed PSA Progression (Up To 12.8 Months))
- PK: Maximum Plasma Concentration at Steady State (Cmax,ss) of Abemaciclib Metabolites (Total Active Species)(C1 D1: Post dose; C1 D15, C2D1, C2D15, C3D1: Pre dose)
- Percentage of Participants With Expression of Ki-67 Proliferation Marker by Immunohistochemistry (IHC)(Baseline)
- Time to Symptomatic Progression(From Date of First Dose until Symptomatic Progression (Up to 12.8 Months))
- Pharmacokinetics (PK): Maximum Plasma Concentration at Steady State (Cmax,ss) of Abemaciclib(Cycle (C) 1 Day (D) 1: Post dose; C1 D15, C2D1, C2D15, C3D1: Pre dose)
- PK: Minimum/Trough Concentration at Steady State (Cmin,ss) of Abemaciclib(C1 D1: Post dose; C1 D15, C2D1, C2D15, C3D1: Pre dose)
- PK: Minimum/Trough Concentration at Steady State (Cmin,ss) of Abemaciclib Metabolites (Total Active Species)(C1 D1: Post dose; C1 D15, C2D1, C2D15, C3D1: Pre dose)
研究者
研究点 (14)
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