NCT01930864Unknown2 期
Phase II Trial of Metformin Combined to Irinotecan for Refractory Metastatic or Recurrent Colorectal Cancer
Barretos Cancer Hospital2 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2015年9月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Non-Progression at week 12th of treatment
研究概览
简要总结
MetIri seeks to identify if metformin combined to irinotecan can improve tumor control.
详细描述
MetIri is a two-stage single arm Phase II assessing the role of combination of metformin to irinotecan for colorectal cancer patients already treat with oxaliplatin, fluoropyrimidine, irinotecan and an anti-EGFr antibody if KRAS wild-type.
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
- •18 years or older
- •Biopsy-proven colorectal adenocarcinoma
- •Ineligibility for curative intent therapy, e.g., surgery or radiation
- •Disease progression after oxaliplatin (either adjuvant or palliative), fluoropyrimidine (either adjuvant or palliative), irinotecan, and if Kras wild type a anti-EGFR therapy
- •Assessable disease according to RECIST v1.1
排除标准
- •known hypersensitivity to metformin or irinotecan
- •Uncontrolled Central nervous system metastasis
- •Acute or chronic severe infection
研究组 & 干预措施
metfomin + irinotecan
Experimental
Irinotecan 350mg/m² q21d + metformin up to 2500mg/d until disease progression, prohibitive toxicity or consent withdrawal
干预措施: metformin (Drug)
metfomin + irinotecan
Experimental
Irinotecan 350mg/m² q21d + metformin up to 2500mg/d until disease progression, prohibitive toxicity or consent withdrawal
干预措施: irinotecan (Drug)
结局指标
主要结局
Non-Progression at week 12th of treatment
时间窗: 12th week
Non-Progression at week 12th of treatment
次要结局
- Overall Survival(12th week)
- Progression-free survival(12th week)
- Quality of life(12th week)
- Safety(12th week)
研究者
研究点 (2)
Loading locations...
相似试验
终止
2 期
Study of Irinotecan & Capecitabine in Metastatic Colorectal CancerSecondaryDrug Therapy, CombinationColorectal NeoplasmsNCT00506168National Cancer Center, Korea37
终止
2 期
Docetaxel in Non Small Cell Lung Cancer (NSCLC)Carcinoma, Non-Small-Cell LungNCT00263016Sanofi50
终止
2 期
Irinotecan in Treating Patients With Metastatic or Inoperable Thyroid CancerHead and Neck CancerNCT00100828Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins6
已完成
2 期
Irinotecan and Cisplatin in Treating Patients Who Are Undergoing Surgery For Locally Advanced Cancer of the Stomach or Gastroesophageal JunctionGastric AdenocarcinomaStage II Gastric CancerStage III Gastric CancerStage IV Gastric CancerNCT00062374National Cancer Institute (NCI)55
已完成
2 期
Combination of Irinotecan and Temozolomide in Children With Brain Tumors.MedulloblastomaGliomaNCT00404495Pfizer83