2025-521327-67-00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
适应症
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
- 32
- 试验地点
- 21
- 主要终点
- Radiographic Progression-Free Survival (rPFS)
研究概览
简要总结
To evaluate the efficacy of inavolisib plus enzalutamide compared with the investigator's choice of control arm (androgen receptor pathway inhibitor (ARPi) switch [enzalutamide or abiraterone] or docetaxel) with respect to radiographic progression-free survival (rPFS)
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 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 castrate-resistant prostate cancer (CRPC)
- •Prior ARPi must have been discontinued as follows: enzalutamide or apalutamide within 3 weeks or abiraterone acetate or darolutamide within 2 weeks prior to start of treatment. In addition, no evidence of radiographic disease progression should have occurred during prior enzalutamide, apalutamide or darolutamide treatment or intolerable toxicity to enzalutamide. First generation androgen receptor inhibitor therapy (e.g., bicalutamide) is allowed and is not considered to be prior ARPi therapy. It must be discontinued > 6 weeks prior to start of treatment.
- •Availability of a tumor tissue specimen that is suitable (e.g., adequate quality and quantity) for use in determining biomarker status
- •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
- •Other concurrent anti-cancer 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
ENZALUTAMIDE, ENZALUTAMIDE
Test
干预措施: ENZALUTAMIDE (Drug)
INAVOLISIB, INAVOLISIB
Test
干预措施: INAVOLISIB (Drug)
DOCETAXEL
Comparator
干预措施: DOCETAXEL (Drug)
ABIRATERONE
Comparator
干预措施: ABIRATERONE (Drug)
结局指标
主要结局
Radiographic Progression-Free Survival (rPFS)
Radiographic Progression-Free Survival (rPFS)
次要结局
- Confirmed Composite Response Rate (RR)
- Confirmed prostate-specific antigen 90 (PSA90)
- Confirmed prostate-specific antigen 50 (PSA50)
- Objective Response Rate (ORR)
- Duration of Response (DOR)
- Overall Survival (OS)
- Incidence and severity of adverse events, with severity determined according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI CTCAE v5.0)
- Change from baseline in selected vital signs
- Change from baseline in selected clinical laboratory test results
研究者
Trial Information System - TISL
Scientific
F. Hoffmann-La Roche AG
研究点 (21)
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