Sym004 versus Standard of Care in metastatic colorectal cancer

Phase 1

• Conditions: Metastatic colorectal cancer with Acquired Resistance to Anti-EGFR Monoclonal Antibodies; MedDRA version: 18.1Level: LLTClassification code 10052362Term: Metastatic colorectal cancerSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2013-003829-29-HU
• Lead Sponsor: Symphogen A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02-04
• Last Update Posted: 24 July 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 240

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified