NCT00083278已完成2 期
A Phase II Study of MDX-010 in Patients With Stage IV Adenocarcinoma of the Breast
Bristol-Myers Squibb25 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2003年5月最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 25
研究概览
简要总结
This Phase II study is designed to treat patients who have been diagnosed with Stage IV Breast Cancer, which has progressed despite treatment with primary therapies, including hormonal therapy, chemotherapy, and antibody therapy. Thirty-three patients will be treated with the monoclonal antibody MDX-010. The initial antitumor activity profile of MDX-010 will be determined, as well as identification of the induction of any antitumor immunity following the MDX-010 treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Provide written informed consent
- •diagnosed with Stage IV adenocarcinoma that has progressed despite previous therapy
- •at least 18 years of age
- •measurable disease defined by RECIST
- •must discontinue any alternative therapy used to treat breast cancer at least 4 weeks prior to enrollment and agree to not use such therapies during the duration of the study (patients may continue to receive tamoxifen, bisphosphate therapy and trastuzumab)
- •prior radiation must be completed at least 4 weeks prior to enrollment
- •ECOG performance status of 0-2
- •Negative pregnancy test
- •Screening lab values must be met
排除标准
- •must be disease free from other cancers for at least 5 years
- •symptomatic or untreated brain metastases
- •active or history of autoimmune disease
- •active HIV, HTLV, HBV or HCV infection
- •concurrent medical condition requiring the use of systemic corticosteroids, must be discontinued at least 4 weeks prior to enrollment
- •prior therapy with anti-CTLA-4 antibody
- •significant organ compromise, uncontrolled heart, liver, lung, or renal disease or other serious illness
- •pregnancy or nursing
研究者
研究点 (25)
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