NCT03617679已完成2 期
A Phase II, Randomized, Double-Blind Study of the Use of Rucaparib vs. Placebo Maintenance Therapy in Metastatic and Recurrent Endometrial Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 79
- 试验地点
- 1
- 主要终点
- Progression Free Survival (PFS)
研究概览
简要总结
This study seeks to determine the effectiveness of Rucaparib as maintenance therapy for metastatic and recurrent endometrial cancer, after 1-2 prior lines of therapy.
详细描述
This is a phase II clinical trial, that administers a maintenance treatment after first line chemotherapy is complete. It is designed to have a 1:1 randomization technique. Half the participants who enter the study will receive the active ingredient, Rucaparib, while the other half will receive a placebo. Treatment will be until progression with follow up until death.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- •Provision to sign and date the consent form.
- •Stated willingness to comply with all study procedures and be available for the duration of the study.
- •Be a female aged 18-
- •Patients with a primary Stage III/IV or recurrent endometrial cancer.
- •Patients have received at least one prior chemotherapy regimen and no more than two prior cytotoxic regimens (including hormonal therapy).
- •Primary chemotherapy regimen must have consisted of at least 4 completed cycles and no more than 8 completed cycles.
- •Previous cytotoxic regimen at least 4 weeks before initiation and no more than 8 weeks from initiation after last dose of previous therapy.
- •Patients who receive radiation to the whole pelvis or at least 50% of the spine must complete radiation therapy and have at least 4 weeks' time elapse prior to initiation of drug.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or
- •Absolute neutrophil count (ANC) > or = 1500 cells/microliters
- •Platelet count > 100,000 microliters
- •Hemoglobin > or = 9.0 g/dL
- •Serum albumin > or = 2.5 g/dL
- •Total bilirubin ≤ 1.5 x ULN (uppler limit of normal)
- •AST and ALT ≤ 3.0 x ULN
- •Serum Creatinine ≤ 1.5x ULN
排除标准
- •An individual who meets any of the following criteria will be excluded from participation in this study:
- •Inability to comply with study and follow-up procedures
- •Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction within the past 3 months, unstable arrhythmias, or unstable angina
- •Known clinically significant liver disease defined as AST and ALT > 3.0 x ULN and/or Total bilirubin > or = 1.5 x ULN, or documented history of active viral, alcoholic, or other hepatitis, cirrhosis, and inherited liver disease
- •Participation in investigational clinical trial within last 30 days
- •History of significant chronic disease including HIV/AIDS or hepatitis C
- •Inability to provide informed consent
- •Known central nervous system (CNS) malignancy or CNS metastases
- •Patients with previous malignancy, other than endometrial, within the past 2 years from cycle 1, day 1, with the exception of those with negligible risk of metastasis or death, such as adequately controlled basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the breast.
- •History of stroke or transient ischemic attack (TIA) within 3 months prior to cycle 1 day 1(C1D1)
- •Women with prognosis for survival less than 6 months
- •Patients who have progressed or have stable disease (SD) through most recent chemotherapy regimen
- •Patients deemed otherwise clinically unfit for clinical trial per Investigator's discretion
- •Patients with duodenal stent or other GI disorder/defect that would interfere with absorption of oral medication
- •Female patients who maintain fertility potential and refuse to comply to use contraception and be followed for pregnancy by pregnancy testing
- •Minor surgical procedure < or = 14 days or major surgeries < or = 28 days prior to first dose of treatment
研究组 & 干预措施
Active Ingredient
Active Comparator
1:1 Randomization. Participants in this arm receive the active ingredient medication.
干预措施: Rucaparib (Drug)
Placebo
Placebo Comparator
1:1 Randomization. Participants in this arm receive the placebo medication. (Placebos do not contain active ingredients).
干预措施: Placebo Oral Tablet (Drug)
结局指标
主要结局
Progression Free Survival (PFS)
时间窗: Up to 48 months.
Progression free survival is defined as cycle 1 day 1 (C1D1) till the time of progression as determined by RECIST 1.1 criteria or death.
次要结局
- Overall Survival (OS)(Up to 48 months.)
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability](Up to 48 months.)
研究者
研究点 (1)
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