NCT00327327已完成1 期
A Phase 1 Trial of Amplimexon® (Imexon, Inj.) Plus Gemcitabine in Advanced, Previously Untreated Pancreatic Adenocarcinoma
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 18
- 主要终点
- Determine maximally tolerated dose (MTD)
研究概览
简要总结
AMP-004 is a Phase 1b dose escalation trial designed to evaluate the safety of the new drug imexon in combination with an approved drug, gemcitabine, for the treatment of patients with previously untreated pancreatic cancer. The treatment consists of dosing with both imexon and gemcitabine on days 1, 8, and 15 of each 28 day cycle. The study is designed to determine the highest doses of the two drugs that can be safely combined together.
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
- •Inoperable cancer of the pancreas.
- •Blood cell counts and blood chemistries in or near normal range.
- •Able to perform the activities of daily living.
- •A projected life expectancy of at least 2 months.
- •If female, neither pregnant nor nursing.
- •Willing to use contraceptives to prevent pregnancy.
- •No other serious illnesses.
- •No other active malignancy.
- •No serious infections.
- •No current other drug therapy for the cancer or steroid therapy.
- •Prior radiation is permitted as is chemotherapy given during radiation or to prevent relapse after surgical removal of the disease.
排除标准
- •Prior chemotherapy for metastatic disease.
- •Brain metastases
结局指标
主要结局
Determine maximally tolerated dose (MTD)
时间窗: until MTD reached
determine dose limiting toxicities.
时间窗: until MTD reached
次要结局
- Changes in plasma thiol levels(until MTD reached)
- objective tumor responses.(until MTD reached)
- pharmacokinetics(until MTD reached)
研究者
研究点 (18)
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