NCT00099970已完成2 期
Phase II Open-Label Study of Volociximab in Combination With DTIC in Patients With Metastatic Melanoma Not Previously Treated With Chemo
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 13
- 主要终点
- Proportion of patients with a confirmed tumor response at any time during the study.
研究概览
简要总结
This clinical trial is being conducted to determine tumor response and preliminary safety of a monoclonal antibody that specifically binds to a cell surface receptor (α5β1 integrin) that is required for the establishment of new blood vessels during tumor growth, a process known as angiogenesis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females of at least 18 years of age with stage IV or unresectable stage III non-ocular melanoma who may have received 0 to 2 prior regimens for metastatic disease with a biological therapy or immunotherapy (e.g., IL-2 or interferon-alfa).
- •Measurable disease according to Response Criteria for Solid Tumors (RECIST).
- •Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to
- •Estimated survival is greater or equal to 4 months.
- •Negative pregnancy test (women of childbearing potential only).
- •Pretreatment laboratory levels that meet specific criteria.
- •Signed informed consent, including permission to use protected health information.
排除标准
- •Prior treatment with M200 or a5b1 inhibitors and murine or chimeric monoclonal antibodies.
- •Prior treatment with DTIC, temozolomide, or other chemotherapeutic regimens.
- •Known sensitivity to murine proteins or chimeric antibodies or other components of the product.
- •Use of any investigational drug within 4 weeks prior to screening or 5 half-lives of the prior investigational drug (whichever is longer).
- •Systemic biologic, immunotherapy, and/or radiation therapy within 4 weeks of the first dose of M
- •Documented central nervous system (CNS) tumor or CNS metastasis.
- •History of thromboembolic events and bleeding disorders within the past year.
- •Medical conditions that may be exacerbated by bleeding.
结局指标
主要结局
Proportion of patients with a confirmed tumor response at any time during the study.
次要结局
- Time to disease progression
- Duration of tumor response
- Immunogenicity
- Pharmacokinetics (PK)
研究者
研究点 (13)
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