EUCTR2013-003829-29-HUActive, not recruitingPhase 1
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
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Symphogen A/S
- Enrollment
- 240
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •- 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
Exclusion Criteria
- •- 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
Investigators
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