Study of BN83495 in Post-menopausal Women With Endometrial Cancer Post-chemotherapy
A Phase II, International, Multicenter, Open-label, Proof of Concept Study of BN83495 in Postmenopausal Women With Advanced, Metastatic or Recurrent Oestrogen Receptor (ER) Positive Endometrial Carcinoma Who Have Received One Line of Chemotherapy in the Adjuvant or Metastatic Setting.
研究概览
研究类型
注册 (实际的)
阶段
- 阶段2
联系人和位置
学习地点
-
-
Ontario
-
London、Ontario、加拿大、N6A 4L6
- London Health Sciences Centre, University of Western Ontario
-
Ottawa、Ontario、加拿大、K1H 8L6
- Department of Oncology, Ottawa Cancer Center
-
Toronto、Ontario、加拿大、M5G 2M9
- Dept of Obstetrics and Gynecology, Princess Margaret Hospital
-
-
Quebec
-
Montreal、Quebec、加拿大、H2L 4M1
- CHUM-Hospital Notre-Dame Service de Gynecologic Oncologique
-
Montreal、Quebec、加拿大、H2W 1S6
- Department of Oncology, McGill University
-
-
-
-
Georgia
-
Augusta、Georgia、美国、30912
- Dept of Obstetrics and Gynecology, Medical College of Georgia
-
-
Minnesota
-
Minneapolis、Minnesota、美国、55455
- Division of Gynecologic Oncology, University of Minnesota Medical Center
-
-
Pennsylvania
-
Philadelphia、Pennsylvania、美国、19104-4283
- Jordan Center for Gynecologic Cancer at Penn, University of Pennsylvania
-
Upland、Pennsylvania、美国、19103
- Crozer Chester Medical Center
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Provision of written informed consent prior to any study related procedures.
- postmenopausal or ovariectomised female patient over 18 years of age.
- histologically confirmed diagnosis of ER positive endometrial carcinoma in the primary tumour or metastatic disease
- patient has received one line of chemotherapy prior to enrolment in the adjuvant or in the metastatic setting (including chemoradiotherapy) and progressed after this line of chemotherapy
- patient has at least one measurable disease site (RECIST criteria version 1.1)
Exclusion Criteria:
- patient has received hormone therapy for endometrial cancer in the adjuvant or metastatic setting
- patient has received more than one line of chemotherapy in the adjuvant or metastatic setting
- patient was treated with any other investigational agent within the 3 weeks before study entry.
- patient has ongoing cardiac dysrhythmias grade ≥2, atrial fibrillation of any grade (NCI CTCAE) or QTcF interval >460 msec.
学习计划
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:BN83495
|
1 tablet of 40 mg, oral, daily until progression or death or unacceptable toxicity develops
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Determination of Clinical Benefit (CB), Defined as Sum of Patients Who Present Complete Response (CR), Partial Response (PR) or Stable Disease (SD) ≥12 Weeks (CB=CR+PR+SD≥12 Weeks) Using Response Evaluation Criteria in Solid Tumors (RECIST Version1.1)
大体时间:12 weeks
|
CR defined as: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR defined as: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD defined as: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease (PD), taking as reference the smallest sum diameters while on study. PD defined as: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). |
12 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Number of Participants With Adverse Events
大体时间:Up to 28 days after last dose
|
Up to 28 days after last dose
|
|
Determination of Time to Progression (TTP) in This Patient Population
大体时间:After the last enrolled patient has been followed for at least 6 months or has progressed or died
|
Time to Progression (TTP): Time from first study treatment to first documentation of objective tumour progression.
|
After the last enrolled patient has been followed for at least 6 months or has progressed or died
|
Determination of Progression Free Survival (PFS) in This Patient Population
大体时间:After the last enrolled patient has been followed for at least 6 months or has progressed or died
|
Progression Free Survival (PFS): Time from first study treatment until objective tumour progression or death from any cause.
|
After the last enrolled patient has been followed for at least 6 months or has progressed or died
|
Determination of Overall Response Rate (ORR) in This Patient Population
大体时间:After the last enrolled patient has been followed for at least 6 months or has progressed or died
|
Overall Response Rate (ORR): Defined as the sum of CR and PR.
|
After the last enrolled patient has been followed for at least 6 months or has progressed or died
|
Determination of Duration of Response in This Patient Population
大体时间:After the last enrolled patient has been followed for at least 6 months or has progressed or died
|
Duration of Response (DR): Time from the first documentation of objective tumour response (defined as CR or PR) to the first documentation of objective tumour progression or death on study due to any cause.
|
After the last enrolled patient has been followed for at least 6 months or has progressed or died
|
Determination of Overall Survival in This Patient Population
大体时间:2 years after the last patient enrolled
|
Overall Survival (OS): Defined as the time from first study treatment to death due to any cause.
|
2 years after the last patient enrolled
|
合作者和调查者
赞助
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
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.
BN83495的临床试验
-
Imperial College LondonUniversity of Southern California; Guy's and St Thomas' NHS Foundation Trust; Ipsen; National Institute... 和其他合作者终止
-
Imperial College LondonCancer Research UK完全的
-
Ipsen完全的子宫内膜癌捷克语, 法国, 英国, 比利时, 拉脱维亚, 匈牙利, 立陶宛, 摩尔多瓦共和国, 波兰, 俄罗斯联邦, 西班牙, 乌克兰