A Study of ABT-263 as Single Agent in Women With Platinum Resistant/Refractory Recurrent Ovarian Cancer (MONAVI-1)
2019年3月15日 更新者：Centre Francois Baclesse
ABT-263 as single agent in women with platinum resistant/refractory recurrent ovarian cancer.
研究概览
研究类型
介入性
注册 (实际的)
47
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
-
Besançon、法国
- CHU Besançon - Hôpital Jean Minjoz
-
Bordeaux、法国
- Institut Bergonie
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Caen、法国
- Centre François Baclesse
-
Lille、法国
- Centre Oscar Lambret
-
Lyon、法国
- CHU
-
Lyon、法国
- Centre Léon Bérard
-
Montpellier、法国
- ICM Val d'Aurelle
-
Nancy、法国
- ICL Institut de Cancérologie de Lorraine
-
Nantes、法国
- Centre Catherine de Sienne
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Nantes、法国
- ICO Centre René Gauducheau
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Nantes、法国
- ICO Paul Papin
-
Nice、法国
- Centre Antoine Lacassagne
-
Paris、法国
- Hôpital Europeén Georges Pompidou
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Paris、法国
- Hôpital Tenon
-
Toulouse、法国
- Institut Claudius Regaud
-
Villejuif、法国
- Gustave Roussy
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
女性
描述
Inclusion Criteria:
- - Woman older than 18 years
- Subjects with Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- Histologically and/or cytologically documented high grade serous epithelial cancer of ovarian, fallopian tube or peritoneum
- Platinum resistant ovarian cancer defined as relapsing within 6 months after a platinum based chemotherapy OR platinum refractory ovarian cancer defined as progressing during a platinum based chemotherapy (excepted refractory patients in first line)
- Subjects having received at least 2 prior lines of treatments including platinum regimen
- Subjects who are willing and able to comply with the protocol and study procedures including willingness to undergo tumor biopsy before therapy at screening
- There is no limitation to prior number of therapies
- Patients must have documented disease progression
- Subjects who have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Adequate bone marrow, renal and hepatic function per local laboratory reference range as follows:• Absolute Neutrophil Count ≥ 1500/ mm3
- Platelets ≥ 150,000 / mm3
- Hemoglobin ≥ 9.0 g/dL
- Renal function: Serum creatinine ≤1.2mg/dL or calculated creatinine clearance ≥ 60mL/min
- AST/ALT ≤ 3.0× the upper limit of normal (ULN); [Subjects with liver metastasis may have AST, ALP, and ALT less then or equal to 5.0 X ULN]
- Bilirubin ≤ 1.25×ULN
- Coagulation: aPTT and PT not to exceed 1.2 × ULN
- LVEF > 50% by echocardiograms or MUGA
- Patients must give written informed consent
Exclusion Criteria:
- Patient's refusal or impossibility to perform biopsy on relapsing disease
- Bowel occlusive syndrome or other gastro-intestinal disorder that does not allow oral medication such as malabsorption
- Patients with platinum refractory disease in first line
- Received radio-immunotherapy within 6 months of 1st dose of study drug
- Received steroid therapy for anti-neoplastic intent within 7 days of the 1st dose of study drug (Inhaled steroids for asthma, topical steroids, replacement/stress corticosteroids, or corticosteroids taken as premedication are allowed)
- Consumption of grapefruit or grapefruit products within 3 days prior to the first dose of study drug
- Patient receiving treatments strong CYP3A4 inhibitors or inducers (Appendix A)
- Positive for HIV and VHC
- Predisposing condition/currently exhibiting signs of bleeding
- Currently receiving anticoagulation therapy, exception of low-dose anticoagulation medications for prophylaxis
- Received aspirin within 7 days of start dose of study drug
- Active peptic ulcer disease / other potentially hemorrhagic esophagitis/gastritis
- Active immune thrombocytopenic purpura, autoimmune hemolytic anemia or history of being refractory to platelet transfusions (within 1 year of 1st dose of study drug)
- Uncontrolled cardiac, renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, or hepatic disease, active systemic fungal infection; diagnosis of fever and neutropenia within 1 week of study drug administration
- A evidence of current/active malignancies other than ovarian cancer
- Pregnant or lactating women
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：ABT-263
oral Navitoclax (ABT-263) daily
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
The primary endpoint is the progression-free survival (PFS) in the whole cohort of patients with a recurrent platinum-resistant ovarian cancer.
大体时间：the time to progression (or death from any cause) from date of randomization until date of first documented progression or date of death from any cause,whichever came first, assessed up to 12 months. Evaluation at interim and final analyses.
|
the time to progression (or death from any cause) from date of randomization until date of first documented progression or date of death from any cause,whichever came first, assessed up to 12 months. Evaluation at interim and final analyses.
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Bim expression level
大体时间：biopsy sample before initiation of treatment by ABT-263 and assessment within 6 months after end of inclusions
|
Bim expression level expressed by immunohistochemistry on biopsy of relapsing tumor at inclusion
|
biopsy sample before initiation of treatment by ABT-263 and assessment within 6 months after end of inclusions
|
|
Response rate
大体时间：evaluated every 6 weeks during treatment to progression or death for any cause.(during average 12 months)]
|
- Response rate defined by a complete response (CR), a partial response (PR) or a stable disease (SD) according to the RECIST v1.1
|
evaluated every 6 weeks during treatment to progression or death for any cause.(during average 12 months)]
|
|
Overall survival (OS)
大体时间：From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months.
|
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months.
|
|
|
Incidence of Treatment-Emergent Adverse Events according to the NCI CTC AE version 4.0
大体时间：From date of treatment start until end of study participation (during average 12 months)]
|
Toxicities
|
From date of treatment start until end of study participation (during average 12 months)]
|
|
Peak Plasma Concentration of ABT-263
大体时间：8-hour post-dose PK on D1 of C1 & 2. Dosage will be done within 12 months after end of inclusions
|
8-hour post-dose PK on D1 of C1 & 2. Dosage will be done within 12 months after end of inclusions
|
|
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Residual concentration of ABT-263
大体时间：Pre-dose 0 and cycles 3, 4, 6 . Dosage will be done within 12 months after end of inclusions
|
Pre-dose 0 and cycles 3, 4, 6 . Dosage will be done within 12 months after end of inclusions
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2016年1月1日
初级完成 (实际的)
2017年4月1日
研究完成 (实际的)
2019年3月1日
研究注册日期
首次提交
2015年10月14日
首先提交符合 QC 标准的
2015年10月28日
首次发布 (估计)
2015年10月29日
研究记录更新
最后更新发布 (实际的)
2019年3月19日
上次提交的符合 QC 标准的更新
2019年3月15日
最后验证
2019年3月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.