NCT05327621招募中2 期
A Single Arm, Open-label, Phase II Study to Assess the Efficacy of Pamiparib in Metastatic Castration-Resistant Prostate Cancer Patients With Homologous Recombination Deficiency (HRD) or BRCA1/2 Mutation
Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年5月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Radiologic Progression-free Survival (rPFS)
研究概览
简要总结
The purpose of this study is to assess the efficacy of a PARP inhibitor, Pamiparib, in metastatic castration-resistant prostate cancer patients with homologous recombination deficiency or BRCA 1 or 2 somatic/germline mutation.
详细描述
This is a single arm, open-label, single center, phase II trial, assessing the efficacy of a PARP inhibitor, Pamiparib, in 50 progressing metastatic castration-resistant prostate cancer patients with at least one line of androgen deprivation therapy or chemotherapy at the metastatic setting, and homologous recombination deficiency or BRCA 1 or 2 somatic or germline mutation.
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
- •≥18 years old, male
- •Have a histologically or cytologically confirmed adenocarcinoma or poorly differentiated carcinoma without neuroendocrine differentiation of the prostate. Mixed histology is accepted, except for small cell carcinoma.
- •Have a deleterious mutation in BRCA1/2 , or HRD score ≥
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤1
- •Metastatic Castration-resistant Prostate Cancer (mCRPC): Presence of measurable target lesion according to RECIST criteria v1.1
- •Male subject has been surgically or medically sterilized and has serum testosterone level ≤1.73nmol/L.
- •Unsterilized male subject uses an acceptable method of contraception (defined as a barrier method with spermicide) to prevent pregnancy during the duration of the study and for 6 months after the last dose of Pamiparib.
- •Experienced disease progression after having received at least 1 prior next-generation androgen receptor-targeted therapies, for metastatic castration-resistant disease.
- •Capable of swallowing the whole capsule.
- •Subjects must have normal organ and bone marrow function at baseline, as defined below:
- •Hemoglobin ≥ 9.0 g/dL at least 28 days after transfusion . Absolute neutrophil count ≥ 1.5 × 10^9/L. Platelet count ≥ 100 × 10^9/L. Total bilirubin ≤ 1.5 × the upper limit of normal (ULN) specified. Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase/alanine aminotransferase (ALT) serum glutamic pyruvic transaminase) ≤ 3 × the specified ULN, unless liver metastases are present, in which case it must be ≤ 5 × ULN.
- •Agree to sign informed consent form
- •Agree not to participate in other interventional trials during this trial.
排除标准
- •Subjects should not enter the study if any of the following exclusion criteria are fulfilled:
- •Acute toxicity (CTCAE > grade 2) due to prior cancer therapy.
- •Received chemotherapy, endocrine therapy, biotherapy, radionuclide therapy, immunotherapy, experimental drugs, proprietary anticancer drugs or Chinese herbal medicines within 5 (if known) half-lives or 14 days(if unknown) prior to the first day of taking Pamiparib; For bisphosphonates or approved bone targeting therapy, Pamiparib must be administered at a steady dose for ≥28 days prior to the first day of taking Pamiparib.
- •Received radiation therapy within 21 days.
- •Prior treatment with any PARP inhibitor. Prior chemotherapy with mitoxantrone or platinum-based chemotherapy or cyclophosphamide. Prior treatment with sipuleucel-T or immune check point inhibitors are allowed.
- •Subjects with major surgery within 2 weeks before starting study treatment. Subjects expected to receive major surgery during the trial.
- •Active second malignancy, with the exception of curatively treated non-melanoma skin cancer, carcinoma in situ, or superficial bladder cancer
- •Symptomatic and/or untreated central nervous system metastases
- •Immunocompromised subjects, such as those with positive human immunodeficiency virus (HIV) serology.
- •Subjects with known active hepatitis (e.g. hepatitis B or C).
- •The subject has a serious cardiovascular disease. ( For example, but not limited to: uncontrolled arrhythmia, myocardial infarction)
- •Concomitant use of strong CYP3A inducers or moderate CYP3A inducers . If half-lives is known, a 5 half-lives washout period is required before the start of Pamiparib therapy and a 2-week washout period is required when the half-lives is unknown.
- •History of intolerance to Pamiparib capsule excipients
- •Excluded by investigators
研究组 & 干预措施
Pamiparib
Experimental
Tablets 20mg per os : 40 mg / bid every day in continuous. Patients will be treated with Pamiparib. Cycles are defined in 28-day periods. Disease response will be assessed every 8 weeks (RECIST 1.1). Safety will be assessed continuously.
干预措施: Pamiparib (Drug)
结局指标
主要结局
Radiologic Progression-free Survival (rPFS)
时间窗: 3 years
Radiologic progression-free survival will be assessed from the time of the first dose to radiologic disease progression or death from any cause, whichever comes first.
次要结局
- Objective Response Rate (ORR)(From enrollment to primary completion of study (up to approximately 3 years))
- Duration of Response (DOR)(From enrollment to primary completion of study (up to approximately 3 years))
- Clinical Benefit Rate(3 years)
- Prostate Specific Antigen (PSA) Response Rate(From enrollment to primary completion of study (up to approximately 3 years))
- Overall Survival (OS)(From enrollment to primary completion of study (up to approximately 3 years))
- Adverse events(3 years)
- Time to PSA Progression(From enrollment to primary completion of study (up to approximately 3 years))
- Time to Response (TTR)(From enrollment to primary completion of study (up to approximately 3 years))
研究者
ZHOU FANGJIAN
Professor
Sun Yat-sen University
研究点 (1)
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