Compassionate Single Subject Use of FG-3019 in Locally Advanced, Unresectable Pancreatic Cancer (Emergency Use of a Test Article)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- FG-3019 treatment regimen to increase OS (overall survival)
研究概览
简要总结
Single compassionate use subject is an 83 year old woman with a history of lymph node positive breast cancer and recently diagnosed pancreatic cancer in May. With an Eastern Cooperative Oncology Group (ECOG) of 2, it is felt that she cannot tolerate more aggressive chemotherapy. The investigators propose to administer FG-3019 on a compassionate pleas basis in combination with gemzar. The patient is currently being treated and is tolerating gemzar.
详细描述
The FG-3019 treatment will be administered over a 28-day cycle:
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Dose: 35 mg/kg
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Route: IV over one hour following completion of gemcitabine infusion
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Schedule:
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Days 1, 8, and 15
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Please note that Day 8 infusion will on be completed during the first treatment cycle
On Drug Evaluation
The patient will be seen prior to every FG-3019 treatment by the treating physician. The following procedures will be conducted at each visit:
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
- 83 Years 至 83 Years（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Signed Consent form
- •Have adequate liver function
- •Have adequate bone marrow function
排除标准
- •History of allergy or hypersensitivity to human, humanized or chimeric monoclonal antibodies
- •Any medical or surgical condition that may place the subject at increased risk while on treatment
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active systemic infection, symptomatic congestive heart failure, unstable angina pectoris, clinically significant cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with treatment requirements
- •Current abuse of alcohol or drugs
研究组 & 干预措施
FG-3019
Treatment of Pancreatic Cancer with FG-3019
干预措施: FG-3019 (Drug)
结局指标
主要结局
FG-3019 treatment regimen to increase OS (overall survival)
时间窗: 7.7 months
次要结局
未报告次要终点