NCT06099990尚未招募1 期
A Multicenter, Randomized, Double-blind Phase Ib/III Clinical Study of Dalpiciclib Isethionate Tablets Combined With Abiraterone Acetate Tablets (I) and Prednisone Tablets (AA-P) Versus Placebo Combined With AA-P in Treatment of High-volume, Metastatic, Hormone-sensitive Prostate Cancer (mHSPC).
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 660
- 主要终点
- Adverse event (AE) incidence
研究概览
简要总结
This study was to evaluate the safety and efficacy of dalcilide tablets in combination with AA-P in the treatment of subjects with high tumor burden mHSPC and to determine the second stage starting dose and progression-free survival（rPFS） based on BICR assessment
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Age of ≥ 18 years old,male
- •ECOG PS score of 0 or 1；
- •Prostate adenocarcinoma confirmed by histological。
- •ADT no more than 3 months prior to randomization (when docetaxel is not used) with no radiographic or PSA progression
- •Receiving or maintaining androgen deprivation therapy (ADT) during the planned study period, i.e. continuous treatment with luteinizing hormone-releasing hormone analogues (LHRHA) (drug castration) or prior bilateral orchiectomy (surgical castration)
- •Voluntarily participate in this clinical trial, understand the study procedure and have signed informed consent
排除标准
- •Previous ADT, chemotherapy, surgery, external radiation exposure, brachytherapy, radiopharmaceuticals, or experimental topical treatments (eg, radiofrequency ablation, cryoponic, high-energy focused ultrasound) for prostate cancer
- •Previous use of CDK4/6 inhibitors (such as piperaciclib, rebocillib and abeceptil), second-generation androgen receptor antagonists (such as enzalutamide, apatamide, darotamide, revilumide and proclomide, etc.), ketoconazole, abiraterone acetate or other investigational drugs that inhibit androgen synthesis (such as TAK-700), other anti-tumor biological therapy, targeted therapy or tumor immunotherapy
- •Confirmed by imaging, there are brain tumor foci
- •History of severe lung disease such as interstitial pneumonia
- •Plan to receive any other antitumor therapy during this trial
- •Inability to swallow, chronic diarrhea and intestinal obstruction, or other factors that affect drug taking and absorption
研究组 & 干预措施
dalpiciclib+ abiraterone+ prednisone
Experimental
干预措施: dalpiciclib isethionate tablets; abiraterone acetate tablets; prednisone tablets (Drug)
placebo+abirarerone+prenisone
Placebo Comparator
干预措施: placebo; abiraterone acetate tablets; prednisone tablets (Drug)
结局指标
主要结局
Adverse event (AE) incidence
时间窗: approximately 63 months
次要结局
- PK： Steady-state trough concentrations of Dalsili and Abiraterone (Cmin, ss)(approximately 6 months)
- PSA response rate(approximately 63 months)
- rPFS(approximately 63 months)
- Time to PSA progression(approximately 63 months)
- ORR(approximately 63 months)
研究者
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