Phase I Clinical Trial of Suberoylanilide Hydroxamic Acid (SAHA) in Combination With Pemetrexed and Cisplatin in Patients With Advanced Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 52
- 主要终点
- Maximum Tolerated Dose (MTD) Status as Determined by Number of Participants With Dose Limiting Toxicity (DLT) at Each Dose Level
研究概览
简要总结
The purpose of this investigational study is to determine the safety and tolerability of oral suberoylanilide hydroxamic acid when administered in combination with standard doses of pemetrexed and cisplatin for the treatment of advanced solid tumors.
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
- •Patient must be 18 years or older with confirmed diagnosis of a solid tumor for which pemetrexed and cisplatin is acceptable treatment and have received no more than 2 prior systemic therapies
- •Has at least 1 measurable lesion
- •Has adequate blood, liver, and kidney functions
- •Has not received any chemotherapy for at least 4 weeks prior to entry in this study
- •Agrees to take adequate measures to prevent pregnancy as outlined in the protocol
排除标准
- •Patient has been treated with other investigational agents with a similar anti-tumor mechanism
- •Patient from Cohorts A and B has received pemetrexed or cisplatin within the past 6 months and from Cohorts C and D have received pemetrexed within the past 6 months
- •Patient from Cohorts A and B has preexisting Grade 2 or higher neuropathy and from Cohorts C and D have Grade 3 or higher neuropathy
- •Patient has active infection or had received IV (intravenous) antibiotic, antiviral, or antifungal medications within 2 weeks of the start of study drugs
- •Patient has HIV, hepatitis B or hepatitis C infection
- •Patient is pregnant or breast feeding
- •Patient has allergy to any component of the study drugs
- •Patient has history of GI (gastrointestinal) surgery or conditions
研究组 & 干预措施
1
vorinostat (Suberoylanilide Hydroxamic Acid [SAHA])
干预措施: vorinostat (Suberoylanilide Hydroxamic Acid [SAHA]) in combination with Pemetrexed and Cisplatin (Drug)
结局指标
主要结局
Maximum Tolerated Dose (MTD) Status as Determined by Number of Participants With Dose Limiting Toxicity (DLT) at Each Dose Level
时间窗: Cycle 1 (21 days)
MTD was determined by the occurrence of DLTs during the first treatment cycle. DLT describes side effects of a drug or other treatment that are serious enough to prevent an increase in dose or level of that treatment. The dose level is equal to the MTD if \< 2 patients experience a DLT and is also the highest tolerated dose level in the cohort.
次要结局
- Safety and Tolerability as Measured by the Number of Participants With Disease Progression(Any time during 8 cycle treatment period through 30 days after.)