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.
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Ipsen
- 入组人数
- 6
- 试验地点
- 9
- 主要终点
- 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)
研究概览
简要总结
The purpose of the protocol is to determine the effect of BN83495 on the progression of endometrial cancer with estrogen receptor in post menopausal women who had previously received chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •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)
排除标准
- •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.
研究组 & 干预措施
BN83495
干预措施: BN83495 (Drug)
结局指标
主要结局
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)
时间窗: 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).
次要结局
- Number of Participants With Adverse Events(Up to 28 days after last dose)
- Determination of Time to Progression (TTP) in This Patient Population(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(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(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(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(2 years after the last patient enrolled)