NCT00109109终止1 期
Phase II Clinical Trial of Oral Suberoylanilide Hydroxamic Acid (SAHA) in Patients With Advanced Multiple Myeloma
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 60
- 主要终点
- PHASE I: Maximum tolerated dose (MTD) of vorinostat in patients with advanced multiple myeloma.
研究概览
简要总结
The purposes of this study are:
- To determine the maximum tolerated dose (MTD) of SAHA administered every 12 hours for 14 consecutive days followed by 7 days of rest during the first two cycles (i.e., first 6 weeks) in patients with advanced multiple myeloma;
- To assess the safety and overall response rate to SAHA in patients with advanced multiple myeloma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Adult patients with refractory or relapsed multiple myeloma, ECOG performance status 0-2 (ECOG)
- •Adequate bone marrow reserve
- •Adequate hepatic and renal function
- •Ability to swallow capsules
- •3 weeks or more from prior chemotherapy and have recovered from prior toxicities
排除标准
- •Patients who plan to go for bone marrow transplant within 4 weeks of start of treatment
- •Patients with prior treatment with other investigational agents with a similar anti-tumor mechanism
- •Patients with other active/uncontrolled clinically significant illnesses
- •Pregnant or nursing female patients
结局指标
主要结局
PHASE I: Maximum tolerated dose (MTD) of vorinostat in patients with advanced multiple myeloma.
PHASE II: Safety and overall response rate to SAHA in patients with advanced multiple myeloma.
次要结局
- 1) Anti-tumor activity in patients with advanced multiple myeloma; 2) Biological effects of SAHA in peripheral mononuclear cells and bone marrow plasma cells; 3) Correlation of biological effects of SAHA with serum drug concentration.
研究者
相似试验
终止
1 期
An Investigational Study of a Histone Deacetylase (HDAC) Inhibitor Plus Targretin in Cutaneous T-Cell Lymphoma Patients (0683-016)(TERMINATED)LymphomaNCT00127101Merck Sharp & Dohme LLC23
终止
1 期
Study of Oral Vorinostat in Combination With Topotecan in Patients With Chemosensitive Recurrent SCLCSmall Cell Lung CancerNCT00697476Armando Santoro, MD2
已完成
1 期
Suberoylanilide Hydroxamic Acid in Advanced Solid TumorsAdvanced CancerNCT00106626Merck Sharp & Dohme LLC52
已完成
2 期
An Investigational Drug Study With Suberoylanilide Hydroxamic Acid in Relapsed Diffuse Large B-cell Lymphoma (0683-013)B-cell LymphomaNCT00097929Merck Sharp & Dohme LLC18
已完成
1 期
Safety Study of AP24534 to Treat Chronic Myelogenous Leukemia (CML) and Other Hematological MalignanciesHematologic MalignanciesChronic Myelogenous LeukemiaNCT00660920Ariad Pharmaceuticals81