2024-510809-28-00招募中3 期
C3441052 - TALAPRO-3: A Phase 3, Randomized, Double-Blind Study of Talazoparib with Enzalutamide Versus Placebo with Enzalutamide in Men with DDR Gene Mutated Metastatic Castration-Sensitive Prostate Cancer
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Pfizer Inc.
- 入组人数
- 207
- 试验地点
- 70
- 主要终点
- Investigator-assessed rPFS per Response Evaluation Criteria in Solid Tumors (RECIST 1.1 [soft tissue disease]) and Prostate Cancer Working Group (PCWG3 [bone disease]) in participants with mCSPC harboring DDR deficiencies.
研究概览
简要总结
To demonstrate that talazoparib in combination with enzalutamide is superior to placebo in combination with enzalutamide in prolonging investigator-assessed Radiographic Progression-free Survival (rPFS), in participants with mCSPC harboring DDR deficiencies.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ 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 neuroendocrine differentiation, small cell or signet cell features
- •Confirmation of DDR gene mutation status by prospective or historical analysis (with sponsor pre-approval) of blood (liquid biopsy) and/or de novo or archival tumor tissue using FoundationOne® Liquid CDx or FoundationOne® CDx
- •Ongoing ADT with a gonadotropin-releasing hormone (GnRH) agonist or antagonist for participants who have not undergone bilateral orchiectomy must be initiated before randomization and must continue throughout the study
- •Metastatic prostate cancer documented by positive bone scan (for bone disease) or metastatic lesions on CT or MRI scan (for soft tissue). Participants whose disease spread is limited to regional pelvic lymph nodes are not eligible. Note: a finding of superscan at baseline is exclusionary
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
排除标准
- •Other acute or chronic medical [concurrent disease, infection, including chronic stable Human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) infection, or co-morbidity] or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that interferes with a participant’s ability to participate in the study, may increase the risk associated with study participation or study treatment administration, or may interfere with the interpretation of study results, and, in the investigator’s judgment, make the participant inappropriate for entry into the study. HIV/HBV/HCV testing is not required unless mandated by local health authority.
- •History of seizure or any condition (as assessed by investigator) that may predispose to seizure
- •Known or suspected brain metastasis or active leptomeningeal disease.
- •Clinically significant cardiovascular disease.
- •Prior treatment in any setting with NHT except prior ADT in the adjuvant/neoadjuvant setting, where the completion of ADT was less than 12 months prior to randomization and the total duration of ADT exceeded 36 months.
- •Any previous treatment with DNA-damaging cytotoxic chemotherapy (ie, platinum based therapy) within 5 years prior to randomization, except for indications other than prostate cancer.
结局指标
主要结局
Investigator-assessed rPFS per Response Evaluation Criteria in Solid Tumors (RECIST 1.1 [soft tissue disease]) and Prostate Cancer Working Group (PCWG3 [bone disease]) in participants with mCSPC harboring DDR deficiencies.
Investigator-assessed rPFS per Response Evaluation Criteria in Solid Tumors (RECIST 1.1 [soft tissue disease]) and Prostate Cancer Working Group (PCWG3 [bone disease]) in participants with mCSPC harboring DDR deficiencies.
次要结局
- OS in participants with mCSPC harboring DDR deficiencies (alpha protected).
研究者
Clinical Medical Lead
Scientific
Pfizer Inc.
研究点 (70)
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