A Phase I, Open-Label, Dose-Escalation Study of the Safety and Tolerability of Ispinesib in Combination With Capecitabine on an Every 21-Day Schedule in Subjects With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Plasma levels for SB-715992 and Capecitabine
研究概览
简要总结
The purpose of this study is to determine the dose regimen of Ispinesib in combination with capecitabine in patients with solid tumors. Ispinesib is dosed by 1-hour intravenous infusion every 3 weeks and capecitabine is dosed orally, twice a day for 14 days with a 1 week rest period. A patient may continue to receive treatment as long as they are benefiting from the treatment. Blood samples will be taken at specific times to measure the amount of both drugs in your body at specific times after the drug is given. Blood samples will also be taken for lab tests such as complete blood counts and clinical chemistries. Physical exams will be performed before each treatment with Ispinesib. During the treatment phase, the patients will undergo regular assessments for safety and clinical response.
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
- •Histologically or cytologically confirmed diagnosis of an advanced solid tumor malignancy that is not responsive to standard therapies or for which there is no standard therapy.
- •ECOG (Eastern Cooperative Oncology Group) Performance Status of 0-
- •Bone marrow function: - ANC greater than 1500/mm
- •Platelet count greater than or equal to 100,000/mm
- •Hemoglobin greater than 9 g/dL.
- •Renal function: - Calculated creatinine clearance greater than or equal to 50 mL.min.
- •Total bilirubin greater than 1.5 mg/dL.
- •AST/ALT less than 2.5 X upper limit of normal.
排除标准
- •Females who are pregnant or nursing.
- •Pre-existing hemolytic anemia.
- •Pre-existing peripheral neuropathy greater than or equal grade
- •Known deficiency in dihydropyrimidine dehydrogenase (DSD).
结局指标
主要结局
Plasma levels for SB-715992 and Capecitabine
时间窗: will be checked at Day 1 for Cycle 1.
次要结局
- - Medical history(at screening)
- - ECOG Performance Status, Physical Exam, vitals, & labs(done at screening, Week 1 (each cycle), & follow-up (f/u))
- - Continuous Adverse Event monitoring(throughout the study)