Phase I/II Study of CT-2106 in Combination With Infusional 5-fluorouracil/Folinic Acid (5-FU/FA)(de Gramont Schedule) as Second Line in Patients With Metastatic Colorectal Cancer Failing an Oxaliplatin Plus 5-FU/FA Regimen

CTI BioPharma2 个研究点分布在 1 个国家目标入组 48 人开始时间: 2004年1月最近更新: 2011年6月8日

适应症

试验速览

阶段: 1 期
状态: 已完成
发起方: CTI BioPharma
入组人数: 48
试验地点: 2
主要终点: Phase I: determine the Maximum Tolerated Dose, dose limiting toxicities, safety profile and antitumor activity

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

CT-2106, a camptothecin (CPT) conjugate, is a new generation of topoisomerase I inhibitors designed to deliver higher, more effective chemotherapy to tumor tissue with less toxicity to normal tissues. The objective of this study is to determine the dose limiting toxicities, safety profile and antitumor activity of CT-2016 in combination with 5-FU and folic acid for the treatment of colorectal cancer.

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 proven metastatic colorectal adenocarcinoma, failing one prior treatment containing oxaliplatin plus 5-FU/FA
•At least one measurable lesion according to RECIST criteria for both Phase I and II
•ECOG performance status 0 or 1
•Adequate hematologic, renal and hepatic function
•Wash out period of at least 4 weeks from surgery, 4 weeks from radiotherapy

排除标准

•Past or concurrent history of neoplasm other than colorectal adenocarcinoma, except curatively treated non melanoma skin cancer or in situ carcinoma of the cervix.
•Pregnant or lactating patients
•Prior treatment with camptothecins
•Presence or history of CNS metastasis or carcinomatous leptomeningitis
•Current active infection per investigator assessment
•Unresolved bowel obstruction or partial obstruction, uncontrolled Crohn's disease or ulcerative colitis
•Current history of chronic diarrhea greater than or equal to grade 1 (CTCAE version 3)

结局指标

主要结局

Phase I: determine the Maximum Tolerated Dose, dose limiting toxicities, safety profile and antitumor activity

时间窗: Each cycle

次要结局

未报告次要终点

研究者

发起方

CTI BioPharma

申办方类型

Industry

研究点 (2)

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