A Retrospective, Multicenter Study of Niraparib as Maintenance Therapy in Patients With Platinum Sensitive Recurrent Ovarian Cancer Who Have Received Niraparib Within the Expanded Access Program (EAP) in Spain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 316
- 试验地点
- 57
- 主要终点
- Niraparib Treatment
研究概览
简要总结
In April 2017, Tesaro, Inc. opened an expanded access program (EAP) to make niraparib, an investigational poly (ADP-ribose) polymerase (PARP) inhibitor, available to eligible women with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer following a complete or partial response to platinum-based chemotherapy, mainly for BRCA wild-type (BRCAwt) tumor patients, a clear unmet medical need for these ovarian cancer patients. As of 19 August 2019, the EAP closing date, there were 446 patients enrolled in 105 Spanish sites.
All eligible deceased and consenting living patients at the participating centers will be included. Data will be directly retrieved from hospital medical records and reported in the electronic Case Report Form (eCRF).
This study seeks to evaluate the safety profile and dose adjustments of niraparib in platinum sensitive recurrent ovarian cancer patients treated in a real world setting within the Spanish expanded access program (EAP).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Female participants 18 years old or older.
- •Participant must be able to understand the study procedures and agree to participate in the study by providing written informed consent.
- •Participant must have received niraparib within the Spanish expanded access program (EAP).
- •Patients must have received at least 1 week of treatment with niraparib.
- •Histological diagnosis of high grade serous ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.
- •Participants must have completed at least 2 previous courses of platinum-containing therapy (e.g., carboplatin, oxaliplatin, or cisplatin).
- •For the penultimate (next to last) platinum-based chemotherapy course prior to enrolment on the program the patient must have platinum sensitive disease after this treatment; defined as achieving a response (complete response (CR) or partial response (PR)) and disease progression occurring no sooner than 6 months, after completion of the last dose of platinum chemotherapy.
- •For the last chemotherapy course prior to inclusion in the program the patient must have received a platinum-containing regimen for a minimum of 4 cycles.
- •For the last chemotherapy course prior to inclusion in the program the Patient must have achieved a partial (PR) or complete (CR) tumor response.
- •The last platinum regimen does not necessarily have to immediately follow the next to last (penultimate) platinum regimen. For example, if a patient received a non-platinum regimen between the penultimate platinum regimen and last platinum regimen, they could be eligible, so long as they meet all entry criteria.
- •When entering the EAP, patients must have met the following:
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 or
- •Adequate organ function - Absolute neutrophil count (ANC) ≥ (greater than or equal to) 1,500/μL.
- •Adequate organ function - Platelets ≥ (greater than or equal to) 100,000/μL.
- •Adequate organ function - Hemoglobin ≥ (greater than or equal to) 9 g/dL.
- •No transfusions of erythrocytes or platelets within 2 weeks prior to assessing adequate hematological blood counts as listed above.
排除标准
- •Patients without medical record available (lost, empty or unretrievable clinical information).
- •Patients who decline consent.
- •Patients who are deceased with prior express order to preserve their data.
结局指标
主要结局
Niraparib Treatment
时间窗: Month 4-6
Niraparib Disease Progression
时间窗: Month 4-6
Best Response Assessment
时间窗: Month 4-6
Niraparib-Related Adverse Events
时间窗: Month 4-6
Relevant Concomitant Medications
时间窗: Month 4-6
Death
时间窗: Month 4-6
Survival Status
时间窗: Month 4-6
Subsequent Therapies for Ovarian Cancer
时间窗: Month 4-6
Demographics
时间窗: Month 4-6
Medical History
时间窗: Month 4-6
Ovarian Cancer Diagnosis
时间窗: Month 4-6
Ovarian Cancer Treatments (pre-Niraparib)
时间窗: Month 4-6
Baseline (pre-Niraparib)
时间窗: Month 4-6
次要结局
未报告次要终点