NCT06887933尚未招募4 期
A Prospective, Multicentre, Open Labelled, Single Arm Phase-IV Clinical Trial of Niraparib in Indian Patients With Advanced or Relapsed Ovarian Cancer Who Are in Complete or Partial Response Following Platinum Based Chemotherapy
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 67
- 主要终点
- Number of participants with treatment-emergent adverse events (TEAEs)
研究概览
简要总结
The goal of this clinical trial is to learn about the safety profile of niraparib in adult female participants for the treatment of advanced or relapsed epithelial ovarian cancer.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Female participants with ≥18 years of age, able to understand the study procedures and agree to participate in the study by providing written informed consent.
- •Histologically confirmed epithelial ovarian cancer.
- •Eligible for active study drug treatment according to the approved label - as monotherapy for the maintenance treatment of adult participants with advanced epithelial (International Federation of Gynecology and Obstetrics [FIGO] stage III and IV) high-grade ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy.
- •as monotherapy for the maintenance treatment of adult participants with platinum-sensitive relapsed high grade serious epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy.
- •Laboratory complete blood count (CBC) criteria (Absolute neutrophil count ≥1,500/microliters [μL]; Platelets ≥100,000/μL; Hemoglobin ≥9 grams per decilitre [g/dL]).
- •Adequately controlled hypertension basis on investigator's discretion.
- •Women of childbearing potential must be ready to use contraceptive measures to avoid pregnancy during study period and until 180 days after the last dose.
排除标准
- •Participant is pregnant, breastfeeding, or expecting to conceive children while receiving study treatment and for up to 180 days after the last dose of study treatment.
- •Participant had known, active hepatic disease, known case of end-stage renal disease (ESRD), known case of serious, uncontrolled medical disorder, any known history or current diagnosis of Myelodysplastic syndrome (MDS) or Acute myeloid leukemia (AML).
- •Any previous polymerases inhibitor (PARPi) treatment.
- •Participant with concomitant serious uncontrolled medical illness.
- •Participant is receiving niraparib for use that is not according to the approved label.
- •Participant with either the history of hypersensitivity to excipients of the study drug or to drugs with a similar chemical structure or class to the study drug.
- •Participant with a previously or currently diagnosed MDS/ AML or pneumonitis.
- •Participants who have not recovered sufficiently from prior surgery or anticancer treatment.
- •Participants who have known history of hepatitis B or hepatitis C.
- •Participant with active infection such as tuberculosis (TB) Prior/concurrent clinical study experience.
- •Participation in another clinical study with a study drug administered in the last 3 months.
- •Judgment by the investigator that the participant should not take part in the study if the participant is unlikely to comply with study procedures, restrictions and requirements.
- •Previous enrolment in the present study.
研究组 & 干预措施
Niraparib
Experimental
干预措施: Niraparib (Drug)
结局指标
主要结局
Number of participants with treatment-emergent adverse events (TEAEs)
时间窗: Up to Day 105
次要结局
- Number of participants with serious adverse events (SAEs), TEAEs leading to death, TEAEs leading to dose reduction, TEAEs leading to treatment discontinuation(Up to Day 105)
研究者
相似试验
已完成
1 期
A Study of Niraparib as Single Agent in Participants With Advanced Solid TumorsAdvanced Solid TumorsNCT03497429Takeda9
已完成
2 期
A Study of Niraparib in Patients With Ovarian Cancer Who Have Received Three or Four Previous Chemotherapy RegimensOvarian NeoplasmsOvarian CancerNCT02354586Tesaro, Inc.463
已完成
2 期
A Study of Niraparib in Patients With Relapsed Ovarian CancerOvarian CancerNCT04392102Zai Lab (Shanghai) Co., Ltd.15
已完成
2 期
An Efficacy and Safety Study of Niraparib in Men With Metastatic Castration-Resistant Prostate Cancer and DNA-Repair AnomaliesProstatic NeoplasmsNCT02854436Janssen Research & Development, LLC289
终止
2 期
Niraparib in the Treatment of Patients With Advanced PALB2 Mutated TumorsSolid TumorColon Tumor, MalignantUrologic CancerMetastatic CancerLocally Advanced Solid TumorEndometrial CancerHead and Neck CancerPancreatic CancerMelanomaEsophageal CancerBreast TumorLung TumorNCT05169437Tempus AI22