2024-511142-39-00招募中3 期
A Phase III, Randomised, Double Blind, Placebo Controlled, Multicentre Study of Olaparib Maintenance Monotherapy in Patients With BRCA Mutated Advanced (FIGO Stage III-IV) Ovarian Cancer Following First Line Platinum Based Chemotherapy.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 88
- 试验地点
- 23
- 主要终点
- Progression Free Survival (PFS) by investigator review of RECIST data
研究概览
简要总结
To determine the efficacy by progression free survival (PFS) investigator assessment according to modified Response Evaluation Criteria in Solid Tumours (RECIST 1.1) of olaparib maintenance monotherapy compared to placebo in BRCA mutated high risk advanced ovarian cancer patients who are in clinical complete response or partial response following first line platinum based chemotherapy.
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Post Treatment Follow Up
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •PRINCIPAL INCLUSION CRITERIA (most important listed). Female patients with newly diagnosed, histologically confirmed, high risk advanced (FIGO stage III – IV) BRCA mutated high grade serous or high grade endometrioid ovarian cancer, primary peritoneal cancer and / or fallopian-tube cancer who have completed first line platinum based chemotherapy (intravenous or intraperitoneal).
- •Stage III patients must have had one attempt at optimal debulking surgery (upfront or interval debulking). Stage IV patients must have had either a biopsy and/or upfront or interval debulking surgery.
- •Documented mutation in BRCA1 or BRCA2 that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function).
- •Patients who have completed first line platinum (eg. carboplatin or cisplatin), containing therapy (intravenous or intraperitoneal) prior to randomisation: • Patients must have, in the opinion of the investigator, clinical complete response or partial response and have no clinical evidence of disease progression on the post treatment scan or rising CA-125 level, following completion of this chemotherapy course. Patients with stable disease on the post-treatment scan at completion of first line platinum-containing therapy are not eligible for the study.
排除标准
- •PRINCIPAL EXCLUSION CRITERIA (the most important are listed). BRCA1 and/or BRCA2 mutations that are considered to be non detrimental (e.g. "Variants of uncertain clinical significance" or "Variant of unknown significance" or "Variant, favour polymorphism" or "benign polymorphism" etc).
- •Patients with early stage disease (FIGO Stage I, IIA, IIB or IIC)
- •Stable disease or progressive disease on the post-treatment scan or clinical evidence of progression at the end of the patient's first line chemotherapy treatment.
- •Patients where more than one debulking surgery has been performed before randomisation to the study. (Patients who, at the time of diagnosis, are deemed to be unresectable and undergo only a biopsy or oophorectomy but then go on to receive chemotherapy and interval debulking surgery are eligible).
- •Patients who have previously been diagnosed and treated for earlier stage ovarian, fallopian tube or primary peritoneal cancer.
- •Patients who have previously received chemotherapy for any abdominal or pelvic tumour, including treatment for prior diagnosis at an earlier stage for their ovarian, fallopian tube or primary peritoneal cancer. (Patients who have received prior adjuvant chemotherapy for localised breast cancer may be eligible, provided that it was completed more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease).
- •Patients with synchronous primary endometrial cancer unless both of the following criteria are met: 1) stage <2 2) less than 60 years old at the time of diagnosis of endometrial cancer with stage IA or IB grade 1 or 2, or stage IA grade 3 endometrioid adenocarcinoma OR ≥ 60 years old at the time of diagnosis of endometrial cancer with Stage IA grade 1 or 2 endometrioid adenocarcinoma. Patients with serous or clear cell adenocarcinoma or carcinosarcoma of the endometrium are not eligible.
结局指标
主要结局
Progression Free Survival (PFS) by investigator review of RECIST data
Progression Free Survival (PFS) by investigator review of RECIST data
次要结局
- Efficacy in patients following First Line Platinum Based Chemotherapy by assessment of: a) overall survival b) time to earliest progression by RECIST or Cancer Antigen-125 (CA- 125) c) time from randomisation to second progression.
- The Trial Outcome Index (TOI) of the Functional Assessment of Cancer Therapy - Ovarian Cancer (FACT-O) will be used to determine: a) Change from baseline in TOI score b) Proportion improved
- Development and delivery of a BRCA mutation companion diagnostic
- Adverse events, physical examination, vital signs including blood pressure, pulse, electrocardiogram and laboratory findings including clinical chemistry and haematology
- Efficacy of olaparib by time to first subsequent therapy or death (TFST).
- Efficacy of olaparib by time to second subsequent therapy or death (TSST).
- Efficacy of olaparib by time from randomisation to study treatment discontinuation or death (TDT).
研究者
AstraZeneca Clinical Study Information Center
Scientific
AstraZeneca AB
研究点 (23)
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