A Phase 1 Study of Chloroquine in Combination With Carboplatin/Gemcitabine in Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Maximum tolerated dose of chloroquine when combined with Carboplatin/Gemcitabine
研究概览
简要总结
The purpose of this research study is to test the safety of chloroquine in combination with carboplatin and gemcitabine and see what effects (good and bad) it has on advanced solid tumors.
Also, the research study will be increasing the dose of chloroquine to find the highest dose of chloroquine that can be given in combination with carboplatin and gemcitabine without causing severe side effects.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed diagnosis of a malignancy that is metastatic or unresectable and for which either standard curative measures do not exist or are no longer effective and carboplatin/gemcitabine is considered a reasonable treatment option whether first line or acceptable and approved combination therapy.
- •Age >18 years of age.
- •Performance status less than or equal 2 (Karnofsky >60%)
- •Life expectancy of greater than 3 months.
- •Adequate labs
- •Measurable disease
排除标准
- •Current treatment with any other investigational agents.
- •Patients with untreated brain metastases
- •History of allergic reaction attributed to compounds of similar chemical or biologic composition to chloroquine or other agents used in study.
研究组 & 干预措施
Chloroquine with Carboplatin/Gemcitabine
Chloroquine administered orally daily to start one week prior to Carboplatin (AUC5)/Gemcitabine (1250mg/m2). Chloroquine dose is escalating.
干预措施: Chloroquine (Drug)
Chloroquine with Carboplatin/Gemcitabine
Chloroquine administered orally daily to start one week prior to Carboplatin (AUC5)/Gemcitabine (1250mg/m2). Chloroquine dose is escalating.
干预措施: Carboplatin (Drug)
Chloroquine with Carboplatin/Gemcitabine
Chloroquine administered orally daily to start one week prior to Carboplatin (AUC5)/Gemcitabine (1250mg/m2). Chloroquine dose is escalating.
干预措施: Gemcitabine (Drug)
结局指标
主要结局
Maximum tolerated dose of chloroquine when combined with Carboplatin/Gemcitabine
时间窗: Up to 12 months
次要结局
- Time to Disease Progression(Up to 24 months)
- Time of Overall Survival(Up to 24 months)