Recruitment

Recruitment Status
Completed
Estimated Enrollment
240

Inclusion Criteria

Acquired resistance to marketed anti-EGFR mAbs as defined in the protocol
Measurable disease defined as one or more target lesions according to RECIST
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 RECIST
Failure of or intolerance to 5-FU, Oxaliplatin, and Irinotecan
Life expectancy of at least 3 months
Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 1
Subjects with histologically or cytologically confirmed mCRC, Kirsten rat sarcoma wild-type (KRAS WT) at initial diagnosis
Other protocol defined inclusion criteria could apply
Written informed consent obtained before undergoing any study-related activities
Male or female, at least 18 years of age

Exclusion Criteria

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)
Magnesium less than 0.9 milligram per deciliter (mg/dL)
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)
Magnesium less than 0.9 milligram per deciliter (mg/dL)
Pretreatment with regorafenib.
Known hypersensitivity to any of the treatment ingredients. Known previous Grade 3-4 infusion related reactions with anti-EGFR mABs
Other protocol defined exclusion criteria could apply
Skin rash Common Terminology Criteria for AEs (CTCAE) Grade greater than 1 from previous anti-EGFR therapy at time of randomization

Summary

Conditions
Metastatic Colorectal Cancer
Type
Interventional
Phase
Phase 2
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

This trial assesses the efficacy of two different weekly dosing regimens of Sym004 (Arm A: 12 mg/kg/week versus Arm B: 9 mg/kg loading dose followed by 6 mg/kg/week) compared with investigator's choice in terms of overall survival time in subjects with mCRC. Subjects assigned to Arm C will receive b...

This trial assesses the efficacy of two different weekly dosing regimens of Sym004 (Arm A: 12 mg/kg/week versus Arm B: 9 mg/kg loading dose followed by 6 mg/kg/week) compared with investigator's choice in terms of overall survival time in subjects with mCRC. Subjects assigned to Arm C will receive best supportive care (BSC), Fluorouracil (5-FU), or Capecitabine, per local standard of care. Subjects will receive treatment until unacceptable toxicity, disease progression, withdrawal of consent, or until the subject meets any of the criteria for treatment discontinuation or trial discontinuation. Therefore, the duration of treatment will differ among individuals and cannot be fixed in advance.

Inclusion Criteria

Acquired resistance to marketed anti-EGFR mAbs as defined in the protocol
Measurable disease defined as one or more target lesions according to RECIST
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 RECIST
Failure of or intolerance to 5-FU, Oxaliplatin, and Irinotecan
Life expectancy of at least 3 months
Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 1
Subjects with histologically or cytologically confirmed mCRC, Kirsten rat sarcoma wild-type (KRAS WT) at initial diagnosis
Other protocol defined inclusion criteria could apply
Written informed consent obtained before undergoing any study-related activities
Male or female, at least 18 years of age

Exclusion Criteria

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)
Magnesium less than 0.9 milligram per deciliter (mg/dL)
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)
Magnesium less than 0.9 milligram per deciliter (mg/dL)
Pretreatment with regorafenib.
Known hypersensitivity to any of the treatment ingredients. Known previous Grade 3-4 infusion related reactions with anti-EGFR mABs
Other protocol defined exclusion criteria could apply
Skin rash Common Terminology Criteria for AEs (CTCAE) Grade greater than 1 from previous anti-EGFR therapy at time of randomization

Tracking Information

NCT #
NCT02083653
Collaborators
Not Provided
Investigators
  • Principal Investigator: Josep Tabernero, MD, PhD Vall d'Hebron University Hospital
  • Josep Tabernero, MD, PhD Vall d'Hebron University Hospital
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