NCT07287150招募中2 期
A Phase II, Randomized, Multicenter, Open-Label Study Evaluating the Efficacy and Safety of the Combination of Inavolisib Plus Enzalutamide Versus Physician's Choice of ARPI or Docetaxel in Patients With Metastatic Castration-Resistant Prostate Cancer
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 48
- 主要终点
- Radiographic Progression-free Survival (rPFS)
研究概览
简要总结
This study will evaluate the efficacy and safety of the combination of inavolisib plus enzalutamide compared with physician's choice of alternative androgen receptor pathway inhibitor (ARPi) or docetaxel in biomarker-selected participants with metastatic castrate-resistant prostate cancer (mCRPC) who have received one prior second-generation ARPi.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 or cytologically confirmed adenocarcinoma of the prostate without small-cell or neuroendocrine features
- •Progressive metastatic CRPC, defined as any of the following: PSA progression, defined by a minimum of two rising PSA values from three consecutive assessments with an interval of at least 7 days between assessments and with a minimal starting value of PSA >=1 ng/mL; The most recent qualifying PSA value must be determined within 14 days of enrollment; Soft tissue disease progression, defined by Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1); Bone disease progression, defined by PCWG3 criteria, with two or more new metastatic bone lesions on a whole-body radionuclide bone scan
- •Treatment with at least one, but no more than one, prior second-generation ARPi (abiraterone, apalutamide, enzalutamide, darolutamide) for hormone- sensitive prostate cancer (HSPC) or CRPC
- •Availability of a tumor tissue specimen that is suitable (e.g., adequate quality and quantity) for use in determining biomarker status
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- •Fasting glucose <100 mg/dL and HbA1c < 5.7%
排除标准
- •Presence of liver metastasis
- •Prior treatment with any phosphatidylinositol-3-kinase (PI3K), protein kinase B (AKT), or mammalian target of rapamycin (mTOR) inhibitor, or with any agent with a mechanism of action of inhibiting the PI3K/AKT/mTOR pathway
- •Type 1 or Type 2 diabetes mellitus
- •Prior treatment for mCRPC with cytotoxic chemotherapy or novel hormonal treatments (e.g., androgen receptor degraders, CYP11 inhibitors), with the following treatments permitted: Prior docetaxel in mHSPC, providing no evidence of disease progression occurred during treatment or within 6 months of treatment completion; Prior docetaxel in the adjuvant or neoadjuvant setting providing no evidence of disease progression occurred during treatment or within 12 months of treatment completion; Prior treatment with sipuleucel-T, with the last dose administered >28 days prior to start of treatment; Prior PARPi therapy, as per local prescribing information, with the last dose administered >14 days prior to start of treatment; One prior RLT or radiotherapeutic agent (e.g., PSMA-targeted RLT, Radium 223) with the last dose administered >8 weeks prior to start of treatment
- •Other concurrent anti-cancer therapy except for androgen deprivation therapy
- •Treatment with strong CYP2C8 inhibitors, strong or moderate CYP2C8 inducers, or strong CYP3A4 inducers within 1 week or 5 drug-elimination half-lives, whichever is longer, prior to initiation of study treatment
- •Transfusion of any blood product for the sole purpose of making a potential participant eligible for study inclusion or within 28 days of enrollment
研究组 & 干预措施
Arm 2
Active Comparator
Participants will receive either ARPi switch (enzalutamide or abiraterone) or docetaxel
干预措施: Enzalutamide (Drug)
Arm 1
Experimental
Participants will receive Inavolisib plus enzalutamide
干预措施: Enzalutamide (Drug)
Arm 2
Active Comparator
Participants will receive either ARPi switch (enzalutamide or abiraterone) or docetaxel
干预措施: Docetaxel (Drug)
Arm 1
Experimental
Participants will receive Inavolisib plus enzalutamide
干预措施: Inavolisib (Drug)
Arm 2
Active Comparator
Participants will receive either ARPi switch (enzalutamide or abiraterone) or docetaxel
干预措施: Abiraterone (Drug)
结局指标
主要结局
Radiographic Progression-free Survival (rPFS)
时间窗: Up to approximately 5 years
次要结局
- Percentage of Participants with Confirmed Prostate-Specific Antigen 90 (PSA90)(Up to approximately 5 years)
- Percentage of Participants with Confirmed Prostate-Specific Antigen 50 (PSA50)(Up to approximately 5 years)
- Objective Response Rate (ORR)(Up to approximately 5 years)
- Duration of Response (DOR)(Up to approximately 5 years)
- Overall Survival (OS)(Up to approximately 5 years)
- Percentage of Participants with Confirmed Composite Response Rate (RR)(Up to approximately 5 years)
- Percentage of Participants With Adverse Events (AEs)(Up to approximately 5 years)
研究者
研究点 (48)
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