NCT00126451终止2 期
A Phase II Clinical Study of Oral Suberoylanilide Hydroxamic Acid in Patients With Relapsed or Refractory Breast, Colorectal, and Non-small Cell Lung Cancer.
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 16
- 主要终点
- Response rate of relapsed/refractory breast, colorectal and non-small cell lung cancer to SAHA using RECIST criteria.
研究概览
简要总结
This is an investigational study to determine the response rate of relapsed/refractory breast, colorectal and non-small cell lung cancer to oral suberoylanilide hydroxamic acid (SAHA), to evaluate PET as an earlier indicator of response to SAHA as assessed by response evaluation criteria in solid tumours (RECIST) criteria and to evaluate the safety and tolerability of oral suberoylanilide hydroxamic acid.
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 breast adenocarcinoma, colorectal carcinoma or non-small cell lung cancer
- •Patients must have relapsed or refractory disease following at least one chemotherapeutic treatment regimen.
- •Has a measurable, positron emission tomography (PET) assessable lesion
- •Adequate blood, liver, bone marrow 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.
排除标准
- •Patient has had prior treatment with histone deacetylase (HDAC) inhibitor.
- •Patient has had treatment with investigational agents within the last 30 days.
- •Patient has active infection or had intravenous (IV) 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 lactating.
- •Patient has allergy to any component of the study drug.
结局指标
主要结局
Response rate of relapsed/refractory breast, colorectal and non-small cell lung cancer to SAHA using RECIST criteria.
次要结局
- Positron emission tomography (PET) as an earlier indicator of the response to SAHA as assessed by RECIST criteria. To evaluate the safety and tolerability of SAHA for 14 days every 21 days.
研究者
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