NCT02655016进行中（未招募）3 期
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Niraparib Maintenance Treatment in Patients With Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- Tesaro, Inc.
- 入组人数
- 733
- 试验地点
- 117
- 主要终点
- Progression Free Survival
研究概览
简要总结
This study aims to assess efficacy of Niraparib (GSK3985771) as maintenance treatment in participants with Stage III or IV ovarian cancer. Participants must have completed front-line platinum based regimen with complete response (CR) or partial response (PR). Data collection for Secondary Outcome measures is ongoing and the approximate duration of the study will be 7 years.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Participants must have histologically diagnosed high-grade serous or endometrioid, or high-grade predominantly serous or endometrioid ovarian cancer, fallopian tube cancer, or primary peritoneal cancer that is Stage III or IV according to Federation Internationale de Gynécologie et d'Obstétrique (FIGO) criteria.
- •Participants with inoperable Stage III and IV disease; All Stage IV participants with operable disease; Participants with stage III or IV disease treated with neoadjuvant chemotherapy and interval debulking surgery; and Participants with stage III disease who have visible residual disease after primary debulking surgery.
- •Participants who have received intraperitoneal chemotherapy; All participants must have had more than or equal to (>=)6 and less than or equal to (<=)9 cycles of platinum-based therapy; Participants must have had >=2 post-operative cycles of platinum-based therapy following interval debulking surgery; Participants must have physician assessed Complete response (CR) or Partial response (PR) after >=3 cycles of therapy; and Participants must have either Cancer antigen 125 (CA-125) in the normal range or CA-125 decrease by more than 90 percent(%) during their front-line therapy that is stable for at least 7 days (no increase more than (>)15% from nadir).
- •Participants must be randomized within 12 weeks of the first day of the last cycle of chemotherapy.
- •All participants must agree to undergo central tumor HRD testing.
- •Participants of childbearing potential must have a negative serum or urine pregnancy test (beta human chorionic gonadotropin [hCG]) within 7 days prior to receiving the first dose of study treatment.
排除标准
- •Participant has mucinous or clear cell subtypes of epithelial ovarian cancer, carcinosarcoma or undifferentiated ovarian cancer.
- •Participants with Stage III disease who have had complete cytoreduction (no visible residual disease) after primary debulking surgery.
- •Participant has undergone more than two debulking surgeries for the study disease.
- •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 has a known hypersensitivity to the components of niraparib or its excipients.
- •Participant has received prior treatment with a known PARP inhibitor or has participated in a study where any treatment arm included administration of a known PARP inhibitor.
- •Participant is to receive bevacizumab as maintenance treatment.
- •Participant has had investigational therapy administered within 4 weeks, or within a time interval less than at least 5 half-lives of the investigational agent, whichever is longer, prior to the first scheduled day of dosing in this study.
- •Participant has had any known >=Grade 3 anemia, neutropenia or thrombocytopenia due to prior chemotherapy that persisted >4 weeks.
- •Participant has a condition (such as transfusion dependent anemia or thrombocytopenia), therapy, or laboratory abnormality that might confound the study results or interfere with the participation for the full duration of the study treatment, including:
- •Participant received a transfusion (platelets or red blood cells) within 2 weeks of the first dose of study treatment.
- •Participant received colony-stimulating factors (e.g., granulocyte colony stimulating factor [G-CSF], granulocyte macrophage colony-stimulating factor [GM-CSF] or recombinant erythropoietin) within 2 weeks prior to the first dose of study treatment.
- •Participant has been diagnosed and/or treated for invasive cancer less than 5 years prior to study enrollment.
研究组 & 干预措施
Participants receiving Niraparib
Experimental
干预措施: Niraparib (Drug)
Participants receiving Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Progression Free Survival
时间窗: Up to 34 months
Progression free survival was defined as the time from the date of treatment randomization to the date of first documentation of disease progression or death due to any cause in the absence of documented progression, whichever occurs first. It was assessed by the blinded independent central review (BICR). Median and 95% confidence interval (CI) are presented.
次要结局
- Overall Survival(Up to 34 months)
- Time to First Subsequent Therapy (TFST)(Up to 34 months)
- Progression-Free Survival-2 (PFS2)(Up to 34 months)
- Change From Baseline in Participant Reported Outcome (PRO): Functional Assessment of Cancer Therapy-Ovarian Symptom Index (FOSI)(Baseline (Day 1, Pre-dose) and Up to Week 24)
- Change From Baseline in PRO: European Quality of Life Scale, 5-dimensions, 5-levels of Severity (EQ-5D-5L) Utility Score(Baseline (Day 1, Pre-dose) and Up to Week 24)
- Change From Baseline in Functional Scales of European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)(Baseline (Day 1, Pre-dose) and Up to Week 24)
- Change From Baseline in Global Health Status/QoL of EORTC-QLQ-C30(Baseline (Day 1, Pre-dose) and Up to Week 24)
- Change From Baseline in Symptoms Scales and Symptoms Items (Dyspnea, Appetite Loss, Insomnia, Constipation, Diarrhea and Financial Difficulty) of EORTC-QLQ-C30(Baseline (Day 1, Pre-dose) and Up to Week 24)
- Change From Baseline in Functional Scales of European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Ovarian Cancer Module (EORTC-QLQ-OV28)(Baseline (Day 1, Pre-dose) and Up to 34 months)
- Change From Baseline in Symptoms Scale of EORTC-QLQ-OV28(Baseline (Day 1, Pre-dose) and Up to 34 months)
研究者
研究点 (117)
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