NCT00401570已完成2 期
Phase 2 Open-Label Study of Volociximab (M200) in Combination With Gemcitabine in Patients With Metastatic Pancreatic Cancer Not Previously Treated With Chemotherapy
AbbVie (prior sponsor, Abbott)6 个研究点 分布在 2 个国家目标入组 40 人开始时间: 2005年3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
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 6
- 主要终点
- The proportion of patients, in each dose cohort, with a confirmed tumor response
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
- Parallel
- 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
- •Male or female, 18 years of age or older.
- •Histologically or cytologically confirmed metastatic adenocarcinoma of the pancreas.
- •May have received prior immunotherapy (including monoclonal antibodies) or vaccine therapies.
- •Measurable disease, according to RECIST criteria.
- •Negative pregnancy test (women of childbearing potential only).
- •Pretreatment laboratory levels that meet specific criteria.
排除标准
- •Prior treatment with Volociximab (M200) or inhibitors of α5β1 integrin (antibodies or small molecules) or gemcitabine and other chemotherapeutic regimens.
- •Known hypersensitivity 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).
- •Monoclonal antibody therapy within 4 weeks of the first dose of Volociximab.
- •Central Nervous System (CNS) tumor or metastasis.
- •History of bleeding disorders within the past year.
- •Medical conditions that may be exacerbated by bleeding.
研究组 & 干预措施
Cohort 1
Experimental
Volociximab (10 mg/kg every other week (qowk)) and Gemcitabine
干预措施: Volociximab (Drug)
Cohort 1
Experimental
Volociximab (10 mg/kg every other week (qowk)) and Gemcitabine
干预措施: Gemcitabine (Drug)
Cohort 2
Experimental
Volociximab (15 mg/kg weekly (qwk)) and Gemcitabine
干预措施: Volociximab (Drug)
Cohort 2
Experimental
Volociximab (15 mg/kg weekly (qwk)) and Gemcitabine
干预措施: Gemcitabine (Drug)
结局指标
主要结局
The proportion of patients, in each dose cohort, with a confirmed tumor response
时间窗: Any time during the course of the trial (up to 104 weeks)
次要结局
- Duration of progression-free survival(During the course of the trial (up to 104 weeks))
- Time to disease progression(During the course of the trial (up to 104 weeks))
- Duration of overall survival(During the course of the trial (up to 104 weeks))
- To evaluate the safety in of M200 in combination with gemcitabine(During the course of the trial (up to 104 weeks))
- To evaluate the pharmacokinetics of M200(During the course of the trial (up to 104 weeks))
- To evaluate the immunogenicity of M200(During the course of the trial (up to 104 weeks))
研究者
研究点 (6)
Loading locations...
相似试验
终止
2 期
Study of M200 (Volociximab) in Patients With Metastatic Renal Cell Carcinoma (RCC)MetastasesRenal Cell CarcinomaNCT00100685Abbott48
已完成
2 期
Volociximab in Combination With DTIC in Patients With Metastatic Melanoma Not Previously Treated With ChemotherapyMetastasesMelanomaNCT00099970PDL BioPharma, Inc.40
Unknown
2 期
Volociximab and Erlotinib in Treating Patients With Stage III or Stage IV Non-Small Cell Lung CancerLung CancerNCT00278187Jonsson Comprehensive Cancer Center
终止
1 期
Study of AK119 Combined With AK104 in Patients With Advanced Solid TumorsSolid Tumor, AdultNCT05559541Akeso33
已完成
1 期
A Phase 1b Study With Volociximab in Combination With Carboplatin, Paclitaxel, and Bevacizumab in First-line, Advanced Non-small Cell Lung Cancer (NSCLC)Non-small Cell Lung CancerNCT00666692Abbott7