NCT00780000终止2 期
Phase 2 Clinical Trial of Intravenous Alvespimycin [KOS-1022] in Patients With Her2 Positive Breast Cancer
Bristol-Myers Squibb0 个研究点目标入组 4 人开始时间: 2008年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 4
- 主要终点
- Objective tumor response rate (either RECIST or WHO complete response, partial response or minor response) confirmed by CT and MRI as the preferred methods for tumor assessments and Chest x-ray is acceptable for pulmonary lesions
研究概览
简要总结
The purpose of this study is to determine the anti-tumor activity (via objective response rate) of alvespimycin in patients with breast cancer who have not previously received trastuzumab (except as adjuvant therapy).
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
- •KPS performance status of >= 80% ("normal activity with effort")
- •Metastatic breast cancer with Her2 amplification by FISH or 3+ Her2 overexpression by immunohistochemistry ("IHC")
- •Must have received no more than one prior cytotoxic chemotherapy regimen in the metastatic setting
- •Measurable disease by RECIST Criteria
排除标准
- •Received prior lapatinib, an investigational ErbB-2 and/or an investigational EGFR dual tyrosine kinase inhibitors
- •Administration of any other chemotherapy, biological, immunotherapy or investigational agent within 14 days prior to receipt of study medication
- •Pregnant or breast-feeding women. Known CNS metastases, unless treated and without clinically significant neurological deficits
- •Moderately severe dry eye
- •Congestive heart failure, or a left ventricular ejection fraction
- •Myocardial infarction or active ischemic heart disease within 12 months prior to study drug administration
- •Previous malignancies unless free of recurrence for at least 5 years
研究组 & 干预措施
A1
Experimental
干预措施: Alvespimycin (Drug)
结局指标
主要结局
Objective tumor response rate (either RECIST or WHO complete response, partial response or minor response) confirmed by CT and MRI as the preferred methods for tumor assessments and Chest x-ray is acceptable for pulmonary lesions
时间窗: Within 28 days prior to the start of treatment with tumor assessments reevaluated every 8 weeks (+/- 4 days)
(all patients were off study by June 2008)
次要结局
- Adverse Events assessed according to the NCI CTCAE (v 3.0) grading system(Within 28 days prior to the start of treatment, and for 167 days)
- Kaplan-Meier estimate of time to response(Within 28 days prior to the start of treatment with tumor assessments reevaluated every 8 weeks (+/- 4 days))
- Kaplan-Meier estimate of time to treatment failure(Within 28 days prior to the start of treatment with tumor assessments reevaluated every 8 weeks (+/- 4 days))
- Laboratory tests assessed according to the NCI CTCAE (v 3.0) grading system(Within 10 days prior to Cycle 1/1st infusion; within 48 hours of infusion (Cycle 1/Weeks 2/3/4 and Cycle 2+/Week3), or within 72 hours prior to infusion (Cycle 2+/Week 1))
- Kaplan-Meier estimate of duration of response(Within 28 days prior to the start of treatment with tumor assessments reevaluated every 8 weeks (+/- 4 days))
- Histopathological and molecular profile of responding and non-responding patients using paraffin-embedded surgical specimens(Specimens were obtained within 28 days prior to the start of treatment)
- Karnofsky Performance Status(Within 28 days prior to the start of treatment, prior to each 4-week cycle starting with Cycle 2, for 167 days)
- Kaplan-Meier estimate of time to progression(Within 28 days prior to the start of treatment with tumor assessments reevaluated every 8 weeks (+/- 4 days))
- Vital signs(Within 28 days prior to the start of treatment, Day1 of Weeks 1, 2, and 3 of Cycle 1 (4 weeks long), and prior to each 4-week cycle starting with Cycle 2, for 167 days)
- Ocular testing(Within 28 days prior to the start of treatment, Cycle 1/Day 10 (3 days +/- 1 day following the 2nd infusion in the first cycle of therapy), prior to Cycle 2, if clinically indicated thereafter, for 167 days)
- Time to progression on the patient's prior cytotoxic chemotherapy compared to the patient's time to progression on alvespimycin(Within 28 days prior to the start of treatment with tumor assessments reevaluated every 8 weeks (+/- 4 days))
- Kaplan-Meier estimate of progression-free survival(Within 28 days prior to the start of treatment with tumor assessments reevaluated every 8 weeks (+/- 4 days))
- Kaplan-Meier estimate of overall survival(Within 28 days prior to the start of treatment with tumor assessments reevaluated every 8 weeks (+/- 4 days))
- Changes in tumor markers(Within 28 days prior to the start of treatment, Prior to each 4-week cycle starting with Cycle 2, for 167 days)
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