Patient Outcomes and Safety of Niraparib as Maintenance Treatment in Patients With Newly Diagnosed Advanced Platinum- Sensitive, Ovarian Cancer. The First Real-World Evidence Study From Poland.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 11
- 主要终点
- Safety and tolerability.
研究概览
简要总结
The study is observational, not interventional. The study will include patients with advanced ovarian cancer who have been treated in Poland based on a previous early access program, and who are currently being treated under the B.50 drug program, funded by the National Health Fund.
Only patients currently being treated in the B.50 program at 10 selected centers listed on this site may be included in the study.
Of course, any patient in Poland eligible for maintenance treatment with niraparib can receive the drug, regardless of participation in this RWE study.The treatment involves administering niraparib as maintenance therapy for 3 years after the completion of chemotherapy, provided that the patient has responded to systemic treatment (NED, CR, PR).
详细描述
Although over the last 2 decades the surgical management of ovarian cancer has improved with more chemotherapy options are available, however 5-year survival rates have remained relatively stable at 25 to 40% (36) The proposed real-life observation study can deliver valuable real-world information about niraparib patient outcomes and safety complementing the results of the PRIMA and PRIME clinical trials. This will also include establishing the importance of KELIM as a predictor of maintenance therapy choices. The multicenter design of the study will allow collection of data from a relatively large and representative group of patients within the Polish Drug program B.50. To this time, no study has been published about niraparib patient outcomes and safety in Poland.
This study will also include evaluation of patient outcomes when initiating therapy up to 4, 8, 12 weeks after completion of platinum based chemotherapy.
The population of patients included in the study will come from two programs: EAP and B.50.
EAP is an early access program sponsored by GSK, which has been operating in Poland since 2021 Jan. The inclusion criteria for EAP contained the same measurable parameters as the B.50 drug program offers.
The B.50 drug program is a ministerial program guaranteeing the Polish patients with advanced ovarian cancer access to approved medicines like maintenance treatment with PARP inhibitors, including niraparib.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
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 be female, ≥18 years of age, able to understand the study procedures, and agree to participate in the study by providing written informed consent.
- •Patients with a histologically confirmed diagnosis of nonmucinous high - grade epithelial ovarian cancer (serous, endometrial) that is stage III or IV according to the FIGO criteria.
- •All patients with Stage IV disease are eligible. This includes those with inoperable disease, those who undergo PDS (R0 or macroscopic disease), or those for whom NACT is planned.
- •Patients with Stage III are eligible if they meet the following criteria:
- •All FIGO III patients in spite of residual disease and cytoreductive surgery.
- •All patients with inoperable Stage III disease.
- •All Stage III patients after NACT chemotherapy.
- •FFPE tumor tissue sample must be available for molecular analysis.
- •Patients of childbearing potential must have a negative serum or urine pregnancy test (beta human chorionic gonadotropin) within 72 hours prior to receiving the first dose of study treatment.
- •Patients must be postmenopausal, free from menses for >1 year, surgically sterilized, or willing to use highly effective contraception to prevent pregnancy (see 0) or must agree to abstain from activities that could result in pregnancy throughout the study, starting with enrollment through 180 days after the last dose of study treatment.
- •Serum creatinine ≤1.5 × upper limit of normal (ULN) or calculated creatinine clearance ≥60 mL/min using the Cockcroft-Gault equation
- •Total bilirubin ≤1.5 × ULN or direct bilirubin ≤1.5 × ULN
- •AST and ALT ≤2.5 × ULN unless liver metastases are present, in which case they must be ≤5 × ULN
- •Patients must have an ECOG score of 0 or
- •Patients must have normal BP or adequately treated and controlled hypertension.
- •Patients must be able to take oral medication.
排除标准
- •Patient has mucinous, germ cell, transitional cell, or undifferentiated tumor.
- •Patient has low-grade or Grade 1 epithelial ovarian cancer.
- •Patient has a known condition, therapy, or laboratory abnormality that might confound the study results or interfere with the patient's participation for the full duration of the study treatment in the opinion of the Investigator.
- •Patient is pregnant or is expecting to conceive children while receiving study drug or for up to 180 days after the last dose of study drug. Patient is breastfeeding or is expecting to breastfeed within 30 days of receiving the final dose of study drug (women should not breastfeed or store breastmilk for use, during niraparib treatment and for 30 days after receiving the final dose of study treatment).
- •Patient has any known history or current diagnosis of MDS or AML.
- •Hypersensitivity to the active substance or to any of the excipients including tartrazine.
- •Hypertension-Participants have systolic BP >140 mmHg or diastolic BP >90 mmHg that has not been adequately treated or controlled.
- •Patients with prior history of PRES.
研究组 & 干预措施
Patients with advanced, high-grade ovarian cancer who respond on the first line therapy (NED, CR,PR)
干预措施: Niraparib 200/300 MG (Drug)
结局指标
主要结局
Safety and tolerability.
时间窗: 27 months
Safety and tolerability of niraparib treatment in Poland. Strict monitoring of safety profile (e.g. blood test is performed every 7 days during first month of treatment and after each changing of dose, blood pressure is performed every 7 days within the first two months then every month within the first year).
PFS measured from the time of the first dose of niraparib.
时间窗: 48 months
The primary PFS analysis will be based upon the Investigator's assessment per Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 criteria, Appendix 2. The day considered as disease progression is the day of the CT examination on which progression was found according to RECIST 1.1 criteria. PFS is defined as the time from first dose of niraparib starting until objective tumor progression or death.
次要结局
- Chemosensitivity based on KELIM.(100 days)
- OS (Overall Survival).(48 months)
- PFS depending on starting niraparib therapy.(48 months)
- DCR (Disease Control Rate).(48 months)
- TFST (Time to the First Subsequent Therapy).(48 months)