NCT00909402已完成1 期
Phase 1b Multiple Ascending Dose Study of BMS-833923 (XL139) Administered in Combination With Cisplatin and Capecitabine as First-Line Therapy in Patients With Inoperable, Metastatic Gastric, Gastroesophageal, or Esophageal Adenocarcinomas
Bristol-Myers Squibb4 个研究点 分布在 2 个国家目标入组 39 人开始时间: 2009年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 39
- 试验地点
- 4
- 主要终点
- Use National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) to establish the MTD, Dose Limiting Toxicity (DLT(s)) and safety profile of BMS-833923 administered in combination with Cisplatin and Capecitabine
研究概览
简要总结
The purpose of this study is to determine the maximum tolerated dose (MTD) of BMS-833923 administered in combination with Cisplatin and Capecitabine as first-line therapy in subjects with inoperable metastatic gastric, gastroesophageal or esophageal adenocarcinomas.
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
- •Esophageal, gastric, or gastroesophageal adenocarcinoma that has spread and cannot be treated with surgery. The diagnosis must be confirmed by a trained pathologist.
- •Prior radiation therapy is allowed in certain circumstances - discuss with your doctor.
- •Individuals who have had surgery may be eligible after recovering from the procedure.
- •Individuals who have received chemotherapy for the treatment of their disease within the past 6 months are not eligible. Chemotherapy given more than 6 months ago is permitted.
- •Individuals with spread of their cancer to the brain are permitted in certain circumstances - talk with your doctor.
排除标准
- •Significant heart disease.
- •Women pregnant or breastfeeding.
- •Women able to bear children who are unwilling or unable to use an acceptable method to avoid pregnancy.
- •Uncontrolled medical condition or active infection
- •Inability to swallow pills.
- •Inability to undergo a blood draw, in which a needle is used to obtain blood from a vein in your arm.
- •Individuals receiving another drug not approved by the Food and Drug Administration (FDA) or similar agency in another country.
- •Prisoners or individuals currently receiving treatment for a mental or physical illness as an inpatient in a hospital.
- •Individuals who have experienced pancreatitis, an inflammation of the pancreas, in the past, or who have had a computed axial tomography (CT) scan showing pancreatitis.
研究组 & 干预措施
All Subjects
Experimental
干预措施: BMS-833923 (Drug)
All Subjects
Experimental
干预措施: Cisplatin (Drug)
All Subjects
Experimental
干预措施: Capecitabine (Drug)
结局指标
主要结局
Use National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) to establish the MTD, Dose Limiting Toxicity (DLT(s)) and safety profile of BMS-833923 administered in combination with Cisplatin and Capecitabine
时间窗: At a minimum on days 1, 8, 15 and 35 of cycle 1, days 1 & 14 for cycle 2 and every 21 days thereafter
MTD - maximum tolerated dose
次要结局
- To evaluate the safety of single-agent BMS-833923, by assessing the evaluation of number, character and duration of adverse event (AE)/serious adverse event (SAE)s(At a minimum on days 1, 8, 15 and 35 of cycle 1, days 1 & 14 for cycle 2 and every 21 days thereafter)
- Pharmacodynamic effects of BMS-833923 will be measured in tumor biopsy samples taken prior to and during single-agent and combination treatment by evaluation of protein or mRNA of biomarkers of Hedgehog (HH) pathway activation, such as GLI-1(During cycle 3)
- The pharmacokinetic parameters that will be assessed include: Cmax (Maximum observed plasma concentration)(During cycles 1, 2 & 3)
- The pharmacokinetic parameters that will be assessed include: Tmax (Time of maximum observed plasma concentration)(During cycles 1, 2 & 3)
- The pharmacokinetic parameters that will be assessed include: AUC(TAU) (Area under the concentration-time curve in one dosing interval)(During cycles 1, 2 & 3)
研究者
研究点 (4)
Loading locations...
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