Multicenter, Two-Stage Study to Evaluate the Safety and Efficacy of Second-Line Metastatic Colorectal Carcinoma Treatment With Recombinant NAPc2
试验速览
- 阶段
- 1 期
- 状态
- 暂停
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Safety measured by major hemorrhage (NCI CTCAE v3.0 grade 3 or greater), during and up to 30 days after completion of study drug administration or, if treatment is ongoing, by 8 months after study enrollment (Stage I) or randomization (Stage II)
研究概览
简要总结
This is a multicenter, two-stage trial with the goal of evaluating up to 100 subjects. This trial will be performed to initiate identification of a safe and effective dose of twice-weekly, subcutaneous rNAPc2 for the second-line treatment of metastatic colorectal carcinoma in combination with contemporary 5-FU-based chemotherapy.
详细描述
Cytotoxic chemotherapy combining 5-fluorouracil and leucovorin with irinotecan (FOLFIRI) or oxaliplatin (FOLFOX) or, more recently, treatment with XELOX (Roche) (capecitabine + oxaliplatin) has been the main approach for the treatment of metastatic colorectal carcinoma (mCRC), but with the advent of targeted therapies, biologic treatments are becoming an area of intense interest. Tissue factor (TF) is a transmembrane glycoprotein expressed by upwards of 85% of mCRCs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Tissue diagnosis of adenocarcinoma of the colon or rectum
- •Documented metastatic disease with at least one measurable lesion by RECIST criteria
- •Previously treated with 5-FU-based chemotherapy in the form of FOLFIRI, FOLFOX, or XELOX plus bevacizumab as first-line chemotherapy and have recorded progressive disease during treatment or after discontinuation of treatment, when discontinuation of treatment occurred less than 6 months before enrollment (Stage I) or randomization (Stage II)
- •Estimated life expectancy of at least 6 months
- •Age 18 to 75 years
- •Last dose of adjuvant or radiosensitizing chemotherapy less than 6 months before enrollment
- •No other active malignancy for which the subject is currently receiving treatment (other than mCRC)
- •No ongoing therapy with or need for parenteral and oral antithrombotics including anticoagulants and anti-platelet agents (including aspirin) and thrombolytics
- •No contraindication to systemic anticoagulation
- •No contraindication to modified FOLFOX6 or FOLFIRI combination chemotherapy
- •No receipt of any investigational compound within 28 days of enrollment
排除标准
- 未提供
结局指标
主要结局
Safety measured by major hemorrhage (NCI CTCAE v3.0 grade 3 or greater), during and up to 30 days after completion of study drug administration or, if treatment is ongoing, by 8 months after study enrollment (Stage I) or randomization (Stage II)
时间窗: 30 days after study completion
次要结局
- Safety measured by adverse events(30 days after study completion)
- Efficacy measured by new metastasis-free survival by 8 months(8 months)
- Survival by 8 months(8 months)
- Arterial or venous thrombosis(8 months)
- Tumor response rate, as assessed by RECIST criteria(30 days after study completion)