NCT00081536Unknown1 期
A Phase I/II Study of Aroplatin and Capecitabine in Subjects With Unresectable Local Recurrence or Distant Metastases of Colorectal Cancer Refractory to 5-FU/Leucovorin and Irinotecan
适应症
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 105
研究概览
简要总结
This study is a Phase I/II study. In Phase I of this study, the objective is to determine the maximum tolerated dose (MTD) of combination therapy with Aroplatin and capecitabine in subjects with unresectable, local recurrence or distant metastases of colorectal cancer refractory to 5-FU/leucovorin and irinotecan. In Phase II, the primary objective is to evaluate the response proportion and duration with Aroplatin/capecitabine therapy. Secondary objectives are to evaluate frequency and severity of adverse events.
详细描述
Phase I Primary Objective:
- Determine the MTD of Aroplatin/capecitabine subjects with unresectable local recurrence or distant metastases of colorectal cancer refractory to 5-FU/LV and irinotecan.
Phase II Primary Objective:
- Evaluate the response proportion and duration with Aroplatin/capecitabine therapy.
Phase II Secondary Objective:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 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
- 未提供
排除标准
- 未提供
研究者
相似试验
Unknown
1 期
Aroplatin and Gemcitabine in Patients With Advanced Pancreatic Cancer Resistant to Standard TherapiesPancreatic NeoplasmsNCT00081549Aronex Pharmaceuticals111
已完成
1 期
CB-839 + Capecitabine in Solid Tumors and Fluoropyrimidine Resistant PIK3CA Mutant Colorectal CancerRectal CancerSolid TumorColorectal CancerColon CancerNCT02861300David Bajor, MD50
已完成
1 期
Carboplatin, Gemcitabine Hydrochloride, and Stereotactic Body Radiation Therapy in Gynecological CancerLeydig Cell TumorOvarian SarcomaOvarian Stromal CancerRecurrent Cervical CancerRecurrent Endometrial CarcinomaRecurrent Fallopian Tube CancerRecurrent Ovarian Epithelial CancerRecurrent Ovarian Germ Cell TumorRecurrent Primary Peritoneal Cavity CancerRecurrent Uterine SarcomaRecurrent Vaginal CancerRecurrent Vulvar CancerPseudomyxoma PeritoneiNCT01652794Case Comprehensive Cancer Center12
Unknown
1 期
A Phase I/II Study of XELOXIRI and Bevacizumab as First-line Treatment in Metastatic Colorectal CancerMetastatic CancerColorectal AdenocarcinomaColorectal CancerNCT04380103Chinese Academy of Medical Sciences106
已完成
2 期
END-1: First Line Chemotherapy for Advanced or Recurrent Endometrial Carcinoma With Carboplatin and Liposomal DoxorubicinEndometrial CancerNCT00401635National Cancer Institute, Naples42