Open-label, Randomized, Controlled, Multicenter Phase II Trial Investigating 2 Sym004 Doses versus Investigator`s Choice (Best Supportive Care, Capecitabine, 5-FU) in Subjects with Metastatic Colorectal Cancer and Acquired Resistance to Anti-EGFR Monoclonal Antibodies

Symphogen A/S0 个研究点目标入组 240 人开始时间: 2014年2月3日最近更新: 2017年8月21日

适应症

试验速览

暂无简介。

•- Written informed consent obtained before undergoing any study-related activities
•- Male or female, at least 18 years of age
•- Subjects with histologically or cytologically confirmed mCRC, KRAS WT at initial diagnosis
•- Failure of or intolerance to 5-FU, Oxaliplatin, and Irinotecan
•- Acquired resistance to marketed anti-EGFR mAbs as defined in the protocol
•- Measurable disease defined as one or more target lesions according to Response Evaluation Criteria in Solid Tumors (RECIST)
•- Life expectancy of at least 3 months
•- ECOG performance status = 1
•- Other predefined inclusion criteria may apply
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 180
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 60

•- Pretreatment with regorafenib
•- Subjects who in the opinion of the subject and investigator would benefit more from regorafenib treatment (except where regorafenib is not reimbursed in the country)
•- Skin rash Common Terminology Criteria for Adverse Events (CTCAE) Grade > 1 from previous anti-EGFR
•therapy at time of randomization
•- Magnesium < 0.9mg/dL
•- Known hypersensitivity to any of the treatment ingredients. Known previous Grade 3-4 infusion related
•reactions with anti-EGFR mABs
•- Other predefined exclusion criteria may apply

发起方