A Phase 2, Open-Label, Single-Arm Study to Evaluate the Safety and Efficacy of Niraparib in Patients With Advanced, Relapsed, High-Grade Serous Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Who Have Received Three or Four Previous Chemotherapy Regimens
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Tesaro, Inc.
- 入组人数
- 463
- 试验地点
- 1
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
This is a Phase 2, open-label, single arm study to evaluate the safety and efficacy of niraparib in ovarian cancer patients who have received three or four previous chemotherapy regimens. Niraparib is an orally active PARP inhibitor. Niraparib will be administered once daily continuously during a 28-day cycle. Health-related quality of life will be measured by Eastern Cooperative Oncology Group performance status (ECOG). Safety and tolerability will be assessed by clinical review of adverse events (AEs), physical examinations, electrocardiograms (ECGs), RECIST tumor assessments and safety laboratory values.
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
- •Patients must agree to undergo tumor HRD testing and blood gBRCAmut status testing.
- •Patients of childbearing potential must have negative pregnancy serum test within 72 hours of being dosed
- •Patients must have histologically diagnosed high-grade (Grade 2 or 3) serous epithelial ovarian, fallopian tube, or primary peritoneal cancer with recurrent disease and must have been previously treated with chemotherapy and experienced a response lasting at least 6 months to first-line platinum based therapy.
- •Patients Must have completed 3 or 4 previous chemotherapy regimens.
- •Patients must have completed their last chemotherapy regimen > 4 weeks prior to treatment initiation.
- •Patients must have measurable disease according to RECIST (v.1.1).
- •Patients must have formalin-fixed, paraffin-embedded tumor samples available from the primary or recurrent cancer or agree to undergo fresh biopsy prior to study treatment initiation.
- •Patients must agree to blood samples during screening and at the end of treatment for cytogenetic analysis.
排除标准
- •Patients must not have any known, persistent (> 4 weeks), ≥Grade 3 hematologic toxicity during the last cancer therapy. Patients must not have any known, persistent (>4 weeks), ≥ Grade 3 fatigue during the last cancer therapy.
- •Patients must not have received pelvic radiotherapy as treatment for primary or recurrent disease within 1 year of the first dose of study treatment.
- •Patients must not have symptomatic uncontrolled brain or leptomeningeal metastases.
- •Patients must not be considered a poor medical risk due to a serious, uncontrolled medical disorder, nonmalignant systemic disease or active, uncontrolled infection.
- •Patients must not have received a transfusion (platelets or red blood cells) within 4 weeks of the first dose of study treatment.
- •Patients must not have known history or current diagnosis of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).
研究组 & 干预措施
Niraparib
干预措施: Niraparib (Drug)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: Up to 3 years
The ORR was defined as the percentage of participants achieving complete response (CR) or partial response (PR) as assessed by the Investigator per Response Evaluation Criteria in Solid Tumors (RECIST) (version1.1), where CR=Disappearance of all target lesions. Any pathological lymph nodes must be \<10 millimeters (mm) in the short axis, PR=At least a 30 percent (%) decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters. Primary Analysis Population comprised of participants who received 3 or 4 prior lines of therapy (LOT), had homologous recombination deficiency positive (HRDpos) tumors, had platinum-sensitive disease, and were poly(adenosine 5'-diphosphate \[ADP\]-ribose) polymerase inhibitors (PARPi) naïve.
次要结局
- Duration of Response (DoR)(Up to 3 years)
- ORR by HRD Status and Breast Cancer Gene (BRCA) Status(Up to 3 years)
- Disease Control Rate (DCR)(Up to 3 years)
- Progression Free Survival(Up to 3 years)
- Overall Survival(Up to 3 years)
- Time to First Subsequent Therapy (TFST)(Up to 3 years)