NCT04288687已完成2 期
PLATPARP: A Phase II Single-Arm Trial of Niraparib in Platinum-Sensitive Castration-Resistant Prostate Cancer With DNA Repair Defects
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- 6-Month Radiographic Progression-Free Survival (rPFS6)
研究概览
简要总结
This study is designed to evaluate the initial safety and effectiveness of an investigational drug, niraparib, given to patients who have recently received platinum-based chemotherapy for the treatment of prostate cancer. The study enrolls participants with history of advanced prostate cancer that is growing despite standard hormonal therapies, such as androgen-deprivation therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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 diagnosis of prostate adenocarcinoma (mixed histology will be acceptable, but pure small cell histology is to be excluded).
- •≥ 18 years of age.
- •No prior therapy with PARP inhibitor therapy.
- •Patients must have received at least 9 weeks of platinum-based chemotherapy for the treatment of mCRPC as the proximal treatment regimen prior to study screening. Patients must not have evidence of clinical or radiographic disease progression (per Investigator assessment) and should have adequately recovered from chemotherapy-related toxicities (at least 4 weeks following completion of chemotherapy, with treatment-related toxicities ≤ grade 1 per CTCAE version 5).
- •ECOG performance status of ≤
- •Documented evidence of a pathogenic or likely pathogenic DNA repair aberration in BRCA1/2, ATM, FANCA, PALB2, CHEK2, HDAC2, or BRIP1 through either somatic or germline testing from a CLIA certified laboratory.
- •Radiographic evidence for metastatic disease. Measureable disease (per RECIST) is not required for enrollment. (i.e. bone-only metastatic disease is permitted).
- •Patients with history of treated brain metastases are eligible if off systemic corticosteroids for at least 2 weeks.
- •Clinical evidence for castration-resistance, with total testosterone < 50 ng/dL. Patients who have not undergone bilateral orchiectomy must plan to continue ongoing androgen deprivation therapy for the duration of the trial therapy.
- •Patients must have adequate organ function, as confirmed by laboratory values obtained ≤ 14 calendar days prior to the first day of study therapy:
- •Hematologic: Absolute neutrophil count (ANC) ≥ 1.5 × 109/L, platelet count ≥ 100 × 109/L, and hemoglobin ≥ 9 g/dL (may have been transfused)
- •Hepatic: Total bilirubin level ≤ 1.5 × the upper limit of normal (ULN) range and AST and ALT levels ≤ 2.5 × ULN or AST and ALT levels ≤ 5 x ULN (for subjects with documented metastatic disease to the liver). (Note: In subjects with Gilbert's syndrome, if total bilirubin is >1.5 × ULN, measure direct and indirect bilirubin and if direct bilirubin is ≤1.5 × ULN, subject may be eligible)
- •Renal: Estimated creatinine clearance ≥ 45 mL/min using Cockcroft Gault formula.
- •Patients must have a projected life expectancy of at least 3 months.
排除标准
- •Prior therapy with a PARP inhibitor.
- •Presence of clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (< 6 months prior to enrollment), myocardial infarction (< 6 months prior to enrollment), unstable angina, congestive heart failure (≥ New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication.
- •Presence of known significant immunodeficiency, as determined by the treating investigator.
- •Presence of clinically significant active infections, as determined by the treating investigator.
- •Known allergy to niraparib or any of its components.
- •Prostate cancer with histologic evidence for pure small cell histology
研究组 & 干预措施
Niraparib Arm (only arm)
Other
Niraparib 200 mg by mouth daily (2 x 100 mg pills) on a 28 day cycle
干预措施: Niraparib Pill (Drug)
结局指标
主要结局
6-Month Radiographic Progression-Free Survival (rPFS6)
时间窗: 6 months from initiation of maintenance niraparib therapy
Proportion of participants alive without radiographic progression (per PCWG2 criteria), clinical deterioration (as assessed by the investigator), or death from any cause, measured from the start of maintenance niraparib therapy using Kaplan-Meier analysis.
次要结局
- Number of Participants With PSA50 Response(From baseline until end of treatment, or up to 24 months)
- Number of Participants With PSA30 Response(From baseline until end of treatment, or up to 24 months)
- Time to PSA Progression(From baseline until end of treatment, or up to 24 months)
- Overall Survival (OS)(From initiation of maintenance niraparib therapy until death from any cause, up to 36 months)
研究者
研究点 (1)
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