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在 mCRPC 患者中评估 CORT125281 联合恩杂鲁胺的研究

2026年4月23日 更新者：Corcept Therapeutics

评估 CORT125281 与恩杂鲁胺在转移性去势抵抗性前列腺癌患者中的安全性、耐受性和药代动力学的 1/2a 期剂量递增和扩展研究

这是一项开放标签的 1/2a 期剂量递增研究，具有扩展期，以评估 CORT125281 与恩杂鲁胺联合治疗转移性去势患者的安全性、耐受性、药代动力学 (PK) 和药效学 (PD) 以及初步疗效 -耐药前列腺癌 (mCRPC) 以确定 2 期研究的推荐剂量 (RD)。

研究概览

地位

终止

条件

干预/治疗

详细说明

CORT125281 是一种选择性糖皮质激素受体 (GR) 拮抗剂。 在这项研究中，CORT125281 将联合恩杂鲁胺口服给药于转移性去势抵抗性前列腺癌 (mCRPC) 患者，以评估该方案的安全性、耐受性、药代动力学、药效学和初步疗效。 该研究包括两个阶段：剂量确定阶段和扩展阶段。 剂量确定阶段旨在确定剂量限制性毒性和 CORT125281 加恩杂鲁胺在 mCRPC 患者中的 RD。 一旦确定了推荐的给药方案，将招募以下扩展队列并在推荐剂量水平上使用 CORT125281 加恩杂鲁胺进行治疗。

双耐药队列：在阿比特龙治疗期间出现疾病进展且未接受其他雄激素受体 (AR) 阻断疗法的患者

ARant-Resistant 队列：在使用恩杂鲁胺或其他第二代 AR 抑制剂治疗期间出现疾病进展的患者。

食物对 CORT125281 PK 的影响将在部分参加扩展阶段的患者中进行评估。 两个扩展队列将同时注册。

在研究的每个阶段，将进行安全性和耐受性的常规评估，并收集样品以确定 CORT125281、恩杂鲁胺及其主要代谢物的标准 PK 参数。 PD、生活质量评估和 CORT125281 与恩杂鲁胺抗肿瘤活性的初步评估将在整个研究过程中进行。

研究类型

介入性

注册 (实际的)

39

阶段

  • 阶段2
  • 阶段1

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 美国
    • Arizona
      • Scottsdale、Arizona、美国、85258
        • Scottsdale
    • Michigan
      • Detroit、Michigan、美国、48201
        • Detroit
    • New Jersey
      • Basking Ridge、New Jersey、美国、07920
        • Basking Ridge
    • New York
      • New York、New York、美国、10065
        • New York
    • Oregon
      • Portland、Oregon、美国、97239
        • Portland
    • Wisconsin
      • Madison、Wisconsin、美国、53792
        • Madison
  • 英国
    • England
      • London、England、英国、W1T7HA
        • London
      • Southampton、England、英国、SO16 6YD
        • Southampton
    • Surrey
      • Sutton、Surrey、英国、SM2 5PT
        • Sutton

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

14年 及以上 (成人、年长者)

接受健康志愿者

不

描述

主要纳入标准：

  • 能够理解研究的目的和风险；愿意并能够遵守预定的访视、治疗计划、实验室测试和其他研究评估和程序，并提供书面知情同意书
  • 签署同意书时年满 18 岁的男性
  • 经组织学证实的前列腺腺癌伴转移性疾病
  • 剂量确定阶段第 1 阶段和扩展阶段：在最近的先前治疗后由 PSA 或影像学定义的进行性疾病。 PSA ≥1 ng/mL，如果确认 PSA 升高是进展的唯一迹象。 PSA 的进展需要 PSA 比之前的参考值升高至少 2 次间隔≥1 周的测量值。 PSA 测量值可以在最近的先前治疗期间或之后收集。

  • 剂量确定阶段第 2 阶段：目前正在接受 PSA 升高的恩杂鲁胺，如下所示：

    1. PSA 升高：相隔 ≥ 1 周至少进行 2 次测量，与最低值相比增加 25%，绝对值 >1 ng/mL。 PSA 测量值可以在最近的先前治疗期间或之后收集。
    2. 患者必须已接受恩杂鲁胺至少 12 周，并且在第 1 周期第 1 天之前至少 4 周接受恩杂鲁胺稳定剂量≥80 mg QD。患者将在筛选期间不间断地继续恩杂鲁胺（无洗脱期） ). 这将是从第 1 周期第 1 天开始与 CORT125281 联合使用的恩杂鲁胺起始剂量。
    3. M0疾病是允许的

  • 扩展阶段：患者在接受以下雄激素导向治疗时必须取得进展：

    1. Abi-Resistant 队列：患者必须在阿比特龙治疗期间出现进展。
    2. 抗 ARant 队列：患者必须在使用恩杂鲁胺或第二代 AR 阻断疗法治疗期间取得进展。 在参加本研究前即刻使用恩杂鲁胺进行治疗的患者必须服用稳定剂量的恩杂鲁胺。 这些患者将在筛选期间不间断地继续使用恩杂鲁胺（不需要清除期）。
  • 在第一次研究治疗（CORT125281 和/或研究中的恩杂鲁胺，以最早者为准）之前 28 天内进行的基线肿瘤评估
  • 血清睾酮 <1.7 nmol/L (50 ng/dL) 的先前手术或化学去势。 如果去势方法是使用黄体生成素释放激素 (LHRH) 类似物，则必须有一个计划在试验期间维持有效的 LHRH 类似物治疗
  • 同意所有协议要求的药效学生物标志物样本，包括治疗前和治疗中配对的肿瘤活检（对一部分患者是强制性的）。
  • 同意提供强制性药物基因组血样（仅限剂量测定部分 1）
  • 东部肿瘤合作组 (ECOG) 表现状态为 0 或 1
  • 在第一次研究治疗（研究中的恩杂鲁胺和/或 CORT125281，以最早者为准）之前 14 天内有足够的基线器官功能
  • 在进入研究后 3 个月内接受全身性皮质类固醇持续时间超过 2 周或有肾上腺功能不全临床证据的患者必须根据清晨血浆皮质醇浓度或 ACTH（促肾上腺皮质激素）刺激试验证明肾上腺功能充足
  • 如果患者与有生育能力的女性发生性关系，则必须在研究治疗（CORT125281 或恩杂鲁胺，以最晚者为准）的最后一剂期间和之后的 100 天内使用含有杀精子剂的避孕套和其他形式的避孕措施。 如果患者与孕妇发生性行为，则在恩杂鲁胺治疗期间和完成治疗后的 100 天内需要使用避孕套。 患者还必须同意在研究期间和最后一次治疗后至少 100 天内避免捐献精子。

主要排除标准：

  • 在首次给予 CORT125281 之前 21 天内接受过化疗、非姑息性放疗、免疫疗法或任何研究性癌症疗法，或计划在方案治疗期间使用此类疗法进行治疗。 在剂量确定阶段第 1 阶段的恩杂鲁胺导入期不允许同时进行抗癌治疗
  • 两种以上用于治疗 mCRPC 的既往细胞毒性化疗方案

剂量确定阶段和扩展阶段将排除以下患者：

  • 剂量确定阶段（仅限第 1 段）
  • 在第 1 周期第 -28 天之前用恩杂鲁胺治疗期间进展（仅适用于接受恩杂鲁胺导入的患者）或
  • 之前接受过第 2 代抗雄激素治疗并需要紧急疾病反应或稳定

  • 扩展阶段 Abi-Resistant 队列：

    • 之前接受过恩杂鲁胺治疗，或
    • 之前接受过第 2 代抗雄激素治疗并需要紧急疾病反应或稳定
  • 扩展阶段抗蚂蚁队列：需要紧急疾病反应或稳定
  • 正在进行或预期的激素治疗（LHRH 类似物除外），包括任何剂量的醋酸甲地孕酮 (Megace)、非那雄胺 (Proscar)、度他雄胺 (Avodart) 或在首次服用 CORT125281 前 28 天内接受过阿比特龙
  • 恩杂鲁胺禁忌症或注意事项
  • 实质性脑转移
  • 任何可能增加研究患者风险或研究者认为将患者置于不可接受风险中的临床显着不受控制的情况
  • 接受过可能降低 PSA 水平或可能具有激素抗前列腺癌活性的草药产品或替代疗法（例如，锯棕榈、PC-SPES、PC-HOPE、圣约翰草、硒补充剂、葡萄籽提取物等）在研究治疗开始后 28 天内或计划在整个研究期间开始使用这些产品/替代疗法进行治疗
  • 在首次服用 CORT125281 之前的 21 天内接受过全身性糖皮质激素治疗，或因医学病症（例如类风湿性关节炎、器官移植后的免疫抑制）需要长期或经常使用的全身性或吸入性糖皮质激素。 如果临床需要（例如 CT 预防），允许非癌症相关原因的短期课程（<5 天）。
  • 与 CYP3A4 或 CYP2C8 的强抑制剂或诱导剂或 CYP3A4、CYP2C9 或 CYP2C19 的敏感底物同时治疗

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：四人间

武器和干预

参与者组/臂
干预/治疗
实验性的：Dose Determination Segment 1 (Open-label) Cohort 1 - 360 mg Exicorilant
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 180 mg (total daily dose 360 mg) and enzalutamide once daily in 28-day dosing cycles.
药品：Exicorilant
Exicorilant is supplied as capsules for oral dosing
其他名称：
  • CORT125281
药品：Enzalutamide
Enzalutamide will be taken orally
其他名称：
  • 新坦迪
实验性的：Dose Determination Segment 1 (Open-label) Cohort 2 - 280 mg Exicorilant
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
药品：Exicorilant
Exicorilant is supplied as capsules for oral dosing
其他名称：
  • CORT125281
药品：Enzalutamide
Enzalutamide will be taken orally
其他名称：
  • 新坦迪
实验性的：Dose Determination Segment 1 (Open-label) Cohort 3 - 280 mg Exicorilant
Patients will not receive lead-in enzalutamide monotherapy. Patients will receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
药品：Exicorilant
Exicorilant is supplied as capsules for oral dosing
其他名称：
  • CORT125281
药品：Enzalutamide
Enzalutamide will be taken orally
其他名称：
  • 新坦迪
实验性的：Dose Determination Segment 2: Arm A - Maximum Dose 240 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 240 mg exicorilant.
药品：Exicorilant
Exicorilant is supplied as capsules for oral dosing
其他名称：
  • CORT125281
药品：Enzalutamide
Enzalutamide will be taken orally
其他名称：
  • 新坦迪
实验性的：Dose Determination Segment 2: Arm A - Maximum Dose 280 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 280 mg exicorilant.
药品：Exicorilant
Exicorilant is supplied as capsules for oral dosing
其他名称：
  • CORT125281
药品：Enzalutamide
Enzalutamide will be taken orally
其他名称：
  • 新坦迪
实验性的：Dose Determination Segment 2: Arm A - Maximum Dose 320 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 320 mg exicorilant.
药品：Exicorilant
Exicorilant is supplied as capsules for oral dosing
其他名称：
  • CORT125281
药品：Enzalutamide
Enzalutamide will be taken orally
其他名称：
  • 新坦迪
实验性的：Dose Determination Segment 2: Arm B - 240 mg Exicorilant
Patients will receive combination treatment with once-daily exicorilant 240 mg, enzalutamide once daily, and placebo in 28-day dosing cycles.
药品：Exicorilant
Exicorilant is supplied as capsules for oral dosing
其他名称：
  • CORT125281
药品：Enzalutamide
Enzalutamide will be taken orally
其他名称：
  • 新坦迪
药品：Placebo
Placebo capsules to match the appearance of the exicorilant capsules
实验性的：Dose Expansion - Abi-Resistant Cohort (Open-label)
Patients who have progressed during treatment with abiraterone and no other androgen receptor-blocking therapies will receive exicorilant and enzalutamide.
药品：Exicorilant
Exicorilant is supplied as capsules for oral dosing
其他名称：
  • CORT125281
药品：Enzalutamide
Enzalutamide will be taken orally
其他名称：
  • 新坦迪
实验性的：Dose Expansion - Abi-Resistant Cohort Food Effect (Open-label)
Subcohort (first 10 patients enrolled into Cohort A). Patients enrolled into this subcohort will receive a single dose of exicorilant at Cycle 1 Day -7 and a single dose of exicorilant at Cycle 1 Day 1 30 minutes after a standard breakfast to assess the effect of food on pharmacokinetic (PK)parameters. Patients will then begin exicorilant in combination with enzalutamide on Cycle 1 Day 2 and continue in 28-day dosing cycles.
药品：Exicorilant
Exicorilant is supplied as capsules for oral dosing
其他名称：
  • CORT125281
药品：Enzalutamide
Enzalutamide will be taken orally
其他名称：
  • 新坦迪
实验性的：Dose Expansion - ARant-Resistant Cohort (Open-label)
Patients who progressed during treatment with enzalutamide or second-generation androgen receptor-blocking (ARant) therapies will receive a daily dose of exicorilant and enzalutamide.
药品：Exicorilant
Exicorilant is supplied as capsules for oral dosing
其他名称：
  • CORT125281
药品：Enzalutamide
Enzalutamide will be taken orally
其他名称：
  • 新坦迪

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Number of Patients With One or More Dose-Limiting Toxicity (DLT)
大体时间：From first dose of exicorilant through completion of Cycle 1 (up to 28 days) for Segment 1 and from first dose of exicorilant through completion of Cycle 3 (up to 84 days) for Segment 2
Assess the maximum tolerated dose (MTD) and/or biologically active doses of exicorilant in combination with enzalutamide to identify the recommended dose (RD) for Phase 2 studies based on the number of patients who experienced a DLT while receiving exicorilant in combination with enzalutamide. DLTs were defined as any of the protocol-specified toxicities that the Investigator considered possibly or probably related to study drug that occurred during the DLT-evaluation period. The MTD is defined as the highest dose at which the DLT rate was <33%.
From first dose of exicorilant through completion of Cycle 1 (up to 28 days) for Segment 1 and from first dose of exicorilant through completion of Cycle 3 (up to 84 days) for Segment 2

次要结果测量

结果测量
措施说明
大体时间
Number of Patients With One or More Treatment-Emergent Adverse Events
大体时间：Up to 27 months for Segment 1 and up to 19 months for Segment 2
The safety of each treatment group will be assessed by evaluating the incidence of treatment-emergent adverse events.
Up to 27 months for Segment 1 and up to 19 months for Segment 2
Area Under the Concentration Versus Time Curve (AUC) of Plasma Exicorilant: Segment 1
大体时间：Predose and at time intervals up to 12 hours postdose on Cycle 1 Day 1 and Cycle 2 Day 1
AUC from time zero to 12 hours postdose (AUC0-12) calculated using linear up and log down method.
Predose and at time intervals up to 12 hours postdose on Cycle 1 Day 1 and Cycle 2 Day 1
Maximum Observed Concentration (Cmax) of Plasma Exicorilant: Segment 1
大体时间：Predose and at time intervals up to 12 hours postdose on Cycle 1 Day 1 and Cycle 2 Day 1
Maximum observed concentration over the dosing interval
Predose and at time intervals up to 12 hours postdose on Cycle 1 Day 1 and Cycle 2 Day 1
AUC of Plasma Enzalutamide: Segment 1
大体时间：Predose and at time intervals up to 24 hours postdose on Cycle 1 Day -1, Cycle 1 Day 1, and Cycle 2 Day 1
AUC from time zero to 24 hours postdose (AUC0-24) calculated using linear up and log down method.
Predose and at time intervals up to 24 hours postdose on Cycle 1 Day -1, Cycle 1 Day 1, and Cycle 2 Day 1
Cmax of Plasma Enzalutamide: Segment 1
大体时间：Predose and at time intervals up to 24 hours postdose on Cycle 1 Day -1, Cycle 1 Day 1, and Cycle 2 Day 1
Maximum observed concentration over the dosing interval
Predose and at time intervals up to 24 hours postdose on Cycle 1 Day -1, Cycle 1 Day 1, and Cycle 2 Day 1
AUC of Plasma N-Desmethyl Enzalutamide: Segment 1
大体时间：Predose and at time intervals up to 24 hours postdose on Cycle 1 Day -1, Cycle 1 Day 1, and Cycle 2 Day 1
AUC0-24 calculated using linear up and log down method.
Predose and at time intervals up to 24 hours postdose on Cycle 1 Day -1, Cycle 1 Day 1, and Cycle 2 Day 1
Cmax of Plasma N-Desmethyl Enzalutamide: Segment 1
大体时间：Predose and at time intervals up to 24 hours postdose on Cycle 1 Day -1, Cycle 1 Day 1, and Cycle 2 Day 1
Maximum observed concentration over the dosing interval
Predose and at time intervals up to 24 hours postdose on Cycle 1 Day -1, Cycle 1 Day 1, and Cycle 2 Day 1
AUC of Plasma Enzalutamide Carboxylic Acid: Segment 1
大体时间：Predose and at time intervals up to 24 hours postdose on Cycle 1 Day -1, Cycle 1 Day 1, and Cycle 2 Day 1
AUC0-24 calculated using linear up and log down method.
Predose and at time intervals up to 24 hours postdose on Cycle 1 Day -1, Cycle 1 Day 1, and Cycle 2 Day 1
Cmax of Plasma Enzalutamide Carboxylic Acid: Segment 1
大体时间：Predose and at time intervals up to 24 hours postdose on Cycle 1 Day -1, Cycle 1 Day 1, and Cycle 2 Day 1
Maximum observed concentration over the dosing interval
Predose and at time intervals up to 24 hours postdose on Cycle 1 Day -1, Cycle 1 Day 1, and Cycle 2 Day 1
AUC of Plasma Exicorilant: Segment 2
大体时间：Predose and at time intervals up to 6 hours on Cycle 1 Day 15 (before dose escalation), and at 2 weeks after each dose escalation (Week 4 for escalation from 240 mg to 280 mg exicorilant and Week 6 for escalation from 280 mg to 320 mg exicorilant).
AUC from time zero to 6 hours postdose (AUC0-6) calculated using linear up and log down method. Patients in Arm B did not receive dose escalations, but they were sampled for pharmacokinetic analysis on the same time frame as the Arm A patients: Cycle 1 Day 15, Week 4, and Week 6.
Predose and at time intervals up to 6 hours on Cycle 1 Day 15 (before dose escalation), and at 2 weeks after each dose escalation (Week 4 for escalation from 240 mg to 280 mg exicorilant and Week 6 for escalation from 280 mg to 320 mg exicorilant).
Cmax of Plasma Exicorilant: Segment 2
大体时间：Predose and at time intervals up to 6 hours on Cycle 1 Day 15 (before dose escalation), and at 2 weeks after each dose escalation (Week 4 for escalation from 240 mg to 280 mg exicorilant and Week 6 for escalation from 280 mg to 320 mg exicorilant).
Maximum observed concentration over the dosing interval. Patients in Arm B did not receive dose escalations, but they were sampled for pharmacokinetic analysis on the same time frame as the Arm A patients: Cycle 1 Day 15, Week 4, and Week 6.
Predose and at time intervals up to 6 hours on Cycle 1 Day 15 (before dose escalation), and at 2 weeks after each dose escalation (Week 4 for escalation from 240 mg to 280 mg exicorilant and Week 6 for escalation from 280 mg to 320 mg exicorilant).
AUC of Plasma Enzalutamide: Segment 2
大体时间：Predose and at time intervals up to 6 hours on Cycle 1 Day 15 (before dose escalation), and at 2 weeks after each dose escalation (Week 4 for escalation from 240 mg to 280 mg exicorilant and Week 6 for escalation from 280 mg to 320 mg exicorilant).
AUC from time zero to 6 hours postdose (AUC0-6) calculated using linear up and log down method. Patients in Arm B did not receive dose escalations, but they were sampled for pharmacokinetic analysis on the same time frame as the Arm A patients: Cycle 1 Day 15, Week 4, and Week 6.
Predose and at time intervals up to 6 hours on Cycle 1 Day 15 (before dose escalation), and at 2 weeks after each dose escalation (Week 4 for escalation from 240 mg to 280 mg exicorilant and Week 6 for escalation from 280 mg to 320 mg exicorilant).
Cmax of Plasma Enzalutamide: Segment 2
大体时间：Predose and at time intervals up to 6 hours on Cycle 1 Day 15 (before dose escalation), and at 2 weeks after each dose escalation (Week 4 for escalation from 240 mg to 280 mg exicorilant and Week 6 for escalation from 280 mg to 320 mg exicorilant).
Maximum observed concentration over the dosing interval. Patients in Arm B did not receive dose escalations, but they were sampled for pharmacokinetic analysis on the same time frame as the Arm A patients: Cycle 1 Day 15, Week 4, and Week 6.
Predose and at time intervals up to 6 hours on Cycle 1 Day 15 (before dose escalation), and at 2 weeks after each dose escalation (Week 4 for escalation from 240 mg to 280 mg exicorilant and Week 6 for escalation from 280 mg to 320 mg exicorilant).
AUC of Plasma N-Desmethyl Enzalutamide: Segment 2
大体时间：Predose and at time intervals up to 6 hours on Cycle 1 Day 15 (before dose escalation), and at 2 weeks after each dose escalation (Week 4 for escalation from 240 mg to 280 mg exicorilant and Week 6 for escalation from 280 mg to 320 mg exicorilant).
AUC from time zero to 6 hours postdose (AUC0-6) calculated using linear up and log down method. Patients in Arm B did not receive dose escalations, but they were sampled for pharmacokinetic analysis on the same time frame as the Arm A patients: Cycle 1 Day 15, Week 4, and Week 6.
Predose and at time intervals up to 6 hours on Cycle 1 Day 15 (before dose escalation), and at 2 weeks after each dose escalation (Week 4 for escalation from 240 mg to 280 mg exicorilant and Week 6 for escalation from 280 mg to 320 mg exicorilant).
Cmax of Plasma N-Desmethyl Enzalutamide: Segment 2
大体时间：Predose and at time intervals up to 6 hours on Cycle 1 Day 15 (before dose escalation), and at 2 weeks after each dose escalation (Week 4 for escalation from 240 mg to 280 mg exicorilant and Week 6 for escalation from 280 mg to 320 mg exicorilant).
Maximum observed concentration over the dosing interval. Patients in Arm B did not receive dose escalations, but they were sampled for pharmacokinetic analysis on the same time frame as the Arm A patients: Cycle 1 Day 15, Week 4, and Week 6.
Predose and at time intervals up to 6 hours on Cycle 1 Day 15 (before dose escalation), and at 2 weeks after each dose escalation (Week 4 for escalation from 240 mg to 280 mg exicorilant and Week 6 for escalation from 280 mg to 320 mg exicorilant).
AUC of Plasma Enzalutamide Carboxylic Acid: Segment 2
大体时间：Predose and at time intervals up to 6 hours on Cycle 1 Day 15 (before dose escalation), and at 2 weeks after each dose escalation (Week 4 for escalation from 240 mg to 280 mg exicorilant and Week 6 for escalation from 280 mg to 320 mg exicorilant).
AUC from time zero to 6 hours postdose (AUC0-6) calculated using linear up and log down method. Patients in Arm B did not receive dose escalations, but they were sampled for pharmacokinetic analysis on the same time frame as the Arm A patients: Cycle 1 Day 15, Week 4, and Week 6.
Predose and at time intervals up to 6 hours on Cycle 1 Day 15 (before dose escalation), and at 2 weeks after each dose escalation (Week 4 for escalation from 240 mg to 280 mg exicorilant and Week 6 for escalation from 280 mg to 320 mg exicorilant).
Cmax of Plasma Enzalutamide Carboxylic Acid: Segment 2
大体时间：Predose and at time intervals up to 6 hours on Cycle 1 Day 15 (before dose escalation), and at 2 weeks after each dose escalation (Week 4 for escalation from 240 mg to 280 mg exicorilant and Week 6 for escalation from 280 mg to 320 mg exicorilant).
Maximum observed concentration over the dosing interval. Patients in Arm B did not receive dose escalations, but they were sampled for pharmacokinetic analysis on the same time frame as the Arm A patients: Cycle 1 Day 15, Week 4, and Week 6.
Predose and at time intervals up to 6 hours on Cycle 1 Day 15 (before dose escalation), and at 2 weeks after each dose escalation (Week 4 for escalation from 240 mg to 280 mg exicorilant and Week 6 for escalation from 280 mg to 320 mg exicorilant).
Objective Response Rate (ORR)
大体时间：Up to 22 months
Confirmed ORR is defined as the proportion of patients with measurable disease at Baseline who achieve a complete regression (CR) or partial regression (PR) by Prostate Cancer Clinical Trials Working Group 3 (PCWG3) / Modified Response Evaluation Criteria in Solid Tumors v1.1 (mRECIST) criteria, after confirmation.
Up to 22 months
Number of Patients With ≥50% Reduction in Prostate-Specific Antigen (PSA)
大体时间：Up to 39 months
Up to 39 months
Time to PSA Progression
大体时间：Up to 39 months
Assess the time to PSA progression defined as the first occurrence of 50% or greater increase in PSA levels. Kaplan-Meier estimates of time to PSA progression were calculated as (earliest date of PSA progression or censoring - date of first study treatment + 1)/30.4375.
Up to 39 months
Percentage of Patients Who Are Progression-Free by PSA Criteria at 4, 6, and 12 Months
大体时间：4, 6, and 12 months
Assess the percentage of patients who are progression-free by PSA criteria, or death. PSA progression was defined as the first occurrence of 50% or greater increase in PSA levels. Values are Kaplan-Meier estimates of the patients progression free at the time points specified.
4, 6, and 12 months
Time to First Symptomatic Skeletal Event (SSE)
大体时间：Up to 39 months
Assess the time to first SSE defined as symptomatic fracture, radiation or surgery to bone, or spinal cord compression. Kaplan-Meier estimates of time to first SSE were calculated as (earliest date of SSE or censoring - date of first study treatment + 1)/30.4375.
Up to 39 months
Time to Progression by Radiographic Criteria
大体时间：Up to 22 months
Assess radiographic progression free survival (PFS) defined as the time interval from first dose of study drug (exicorilant and/or enzalutamide) to the date when the first site of disease progression is found on computerized tomography (CT), magnetic resonance imaging (MRI), or radionucleotide bone scan per PCWG3/mRECIST v1.1, or death whichever occurs first. The data values are Kaplan-Meier estimates.
Up to 22 months
Percentage of Patients Who Are Progression-Free by Radiographic Criteria at 4, 6, and 12 Months
大体时间：4, 6, and 12 months
Assess the percentage of patients who are progression-free by radiographic criteria per PCWG3/RECIST v1.1, or death whichever occurs first. Values are Kaplan-Meier estimates of the patients progression free at the time points specified.
4, 6, and 12 months
Time to Progression by Clinical or Radiographic Criteria
大体时间：Up to 22 months
Determine PFS by clinical or radiographic criteria, or death, whichever occurs first. Clinical progression was defined as treatment discontinuation due to disease progression by investigator assessment per PCWG3/mRECIST v1.1, or by PSA criteria. The data values are Kaplan-Meier estimates.
Up to 22 months
Percentage of Patients Who Are Progression-Free by Clinical or Radiographic Criteria at 4, 6, and 12 Months
大体时间：4, 6, and 12 months
Assess the percentage of patients who are progression-free by clinical or radiographic measures at 4, 6, and 12 months. Values are Kaplan-Meier estimates of the patients progression free at the time points specified.
4, 6, and 12 months
Time to Progression by Clinical or Biochemical Criteria
大体时间：Up to 33 months
Determine PFS by clinical criteria or biochemical criteria (defined as treatment discontinuation due to clinical progression by investigator assessment, or by PSA criteria) PCWG3/mRECIST v1.1, or death whichever occurs first. The data values are Kaplan-Meier estimates.
Up to 33 months
Percentage of Patients Who Are Progression-Free by Clinical or Biochemical Criteria at 4, 6, and 12 Months
大体时间：4, 6, and 12 months
Assess the percentage of patients who are progression-free by clinical or biochemical criteria (defined as treatment discontinuation due to clinical progression by investigator assessment or by PSA criteria) PCWG3/mRECIST v1.1, or death whichever occurs first at 4, 6, and 12 months. Values are Kaplan-Meier estimates of the patients progression free at the time points specified.
4, 6, and 12 months
Duration of Response (DOR)
大体时间：Up to 11 months
Determine the DOR as defined as the time from the first occurrence of a documented objective tumor response to the time of radiographic progression (per investigator using PCWG3/mRECIST v1.1 criteria) or death from any cause on study, whichever occurs first. DOR was calculated as (earliest date of progression, death, or censoring - date of first documented objective response +1)/30.4375. The data values are Kaplan-Meier estimates.
Up to 11 months
Overall Survival (OS)
大体时间：Up to 52 months
Determine OS assessed as the time from the first dose of study drug (exicorilant and/or enzalutamide) to the date of death from any cause. The data values are Kaplan-Meier estimates.
Up to 52 months

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Corcept Therapeutics

调查人员

  • 研究主任：Grace Mann, PhD、Corcept Therapeutics
  • 研究主任：William Guyer, PharmD、Corcept Therapeutics

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研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2018年2月20日

初级完成 (实际的)

2021年10月13日

研究完成 (实际的)

2023年1月12日

研究注册日期

首次提交

2018年1月16日

首先提交符合 QC 标准的

2018年2月15日

首次发布 (实际的)

2018年2月19日

研究记录更新

最后更新发布 (实际的)

2026年5月15日

上次提交的符合 QC 标准的更新

2026年4月23日

最后验证

2026年4月1日

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与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • CORT125281-601
  • 2017-003287-12 (EudraCT编号)

计划个人参与者数据 (IPD)

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不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

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