NCT04822961Unknown2 期
A Randomized, Double-Blinded, Placebo-Controlled, Multicenter, Phase II Study to Evaluate Senaparib in mCRPC Patients With Homologous Recombination Repair Gene Alterations After Docetaxel Treatment
Impact Therapeutics, Inc.6 个研究点 分布在 3 个国家目标入组 285 人开始时间: 2021年12月31日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 285
- 试验地点
- 6
- 主要终点
- rPFS assessed by BICR
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of Senaparib in metastatic castration-resistant prostate cancer (mCRPC) patients with homologous recombination repair (HRR) gene alterations after docetaxel treatment
详细描述
This is a randomized, double-blinded, placebo-controlled, multicenter, Phase II study in mCRPC patients with HRR gene alterations after docetaxel therapy to evaluate the anti-tumor activity and safety of Senaparib.
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
- Double (Participant, Investigator)
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
- •Patients must voluntarily participate in this clinical study. Be willing written informed consent form (ICF) prior to any study activity.
- •Male ≥18 years of age on the day of signing the ICF.
- •Patients must have histologically or cytologically confirmed prostate adenocarcinoma.
- •Surgically or medically castrated, with serum testosterone levels of ≤50 ng/dL (≤1.73 nmol/L). If the patient is being treated with LHRH agonists/antagonists (patient who have not undergone orchiectomy), this therapy must be continued throughout the study.
- •Patients have adequate organ functions, as indicated by the following laboratory values (had not received blood transfusion, apheresis infusion, erythropoietin, granulocyte colony-stimulating factor (G-CSF), and other relevant medical support within 14 days before the administration of study drug).
- •Patients have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to
- •Male patients must use a condom during treatment and for 3 months after the last dose of study drug when having sexual intercourse with a woman of childbearing potential. Female partners of male patients should also use an acceptable method of contraception if they are of childbearing potential.
排除标准
- •Previous allogenic bone marrow transplant or double umbilical cord blood transplantation (dUCBT).
- •Prior treatment with a polyadenosine 5'diphosphoribose polymerisation (PARP) inhibitor, including Senaparib.
- •Patients with a known hypersensitivity to Senaparib or any of the component of Senaparib.
- •Initiating bisphosphonate/denosumab therapy or adjusting bisphosphonate/denosumab dose/regimen within 28 days prior to the first dose of study drug. Patients on a stable bisphosphonate/denosumab regimen are eligible and may continue.
- •Patients who have received strong inhibitors/inducers of CYP3A4 which cannot be discontinued 21 days prior to the first dose of study drug and withheld throughout the study drug treatment. Patients received phenobarbital/enzalutamide will require a 5-week washout prior to the first dose of study drug.
- •Patients with MDS or AML, or with clinical features suggestive of MDS or AML.
- •Patients with serious acute or chronic infections.
- •Patients who have received a live virus or bacterial or RNA vaccination within 28 days prior to the first dose of study drug.
- •Patients are unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designee.
研究组 & 干预措施
Senaparib (IMP4297) 20 mg
Experimental
During the treatment period, eligible patients will receive single agent of Senaparib at a dose of 100 mg once daily (QD), continuously on a 4-week cycle
干预措施: Placebo (Drug)
Placebo
Placebo Comparator
During the treatment period, eligible patients will receive placebo QD, continuously on a 4-week cycle
干预措施: Senaparib (Drug)
结局指标
主要结局
rPFS assessed by BICR
时间窗: 80 weeks
To evaluate the impact of Senaparib on radiographic progression free survival (rPFS), compared with the placebo, in metastatic castration-resistant prostate cancer (mCRPC) patients with BRCA1/2 gene alteration who have not progressed after docetaxel therapy assessed by Blinded Independent Central Review (BICR).
次要结局
- OS(80 weeks)
- PFS2(80 weeks)
- Objective response rate (ORR) according to RECIST v1.1 assessed by investigator(80 weeks)
- PSA response rate according to PCWG3 criteria assessed by central laboratory(80 weeks)
- rPFS assessed by BICR(80 weeks)
- Time to PSA progression(80 weeks)
- Time to pain progression(80 weeks)
- Objective response rate (ORR) according to RECIST v1.1 assessed by BICR(80 weeks)
- Cmax(80 weeks)
- Time from randomization to the first SSRE(80 weeks)
- rPFS assessed by the investigator(80 weeks)
- Safety endpoints(80 weeks)
研究者
研究点 (6)
Loading locations...
相似试验
已完成
2 期
Rucaparib vs Placebo Maintenance Therapy in Metastatic and Recurrent Endometrial CancerMetastatic Endometrial CancerNCT03617679University of Colorado, Denver79
已完成
3 期
Study of Pembrolizumab (MK-3475) Versus Placebo in Participants With Esophageal Carcinoma Who Are Receiving Chemotherapy and Radiation Therapy (MK-3475-975/KEYNOTE-975)Esophageal Squamous Cell Carcinoma (ESCC)Gastroesophageal Junction Carcinoma (GEJC)Esophageal Adenocarcinoma (EAC)NCT04210115Merck Sharp & Dohme LLC703
招募中
2 期
Pamiparib in mCRPC With HRD or BRCA1/2 MutationMetastatic Castration-resistant Prostate CancerNCT05327621Sun Yat-sen University50
已完成
2 期
A Study Evaluating Effects of Intranasal JNJ-17166864 on Symptoms of Allergic Rhinitis in AdultsAllergic RhinitisNCT00604123Johnson & Johnson Pharmaceutical Research & Development, L.L.C.74
尚未招募
2 期
PARP-inhibitor on Advanced Metastatic Breast Cancer in Germline PALB2 Mutations CarriersMetastatic Breast Cancer in Germline-PALB2 Mutations CarriersNCT05232006Assistance Publique - Hôpitaux de Paris12