Sym004 vs Standard of Care in Subjects With Metastatic Colorectal Cancer
Last updated on April 2022Recruitment
- Recruitment Status
- Completed
- Estimated Enrollment
- 240
Inclusion Criteria
- Subjects with histologically or cytologically confirmed mCRC, Kirsten rat sarcoma wild-type (KRAS WT) at initial diagnosis
- Acquired resistance to marketed anti-EGFR mAbs as defined in the protocol
- Written informed consent obtained before undergoing any study-related activities
- ...
- Subjects with histologically or cytologically confirmed mCRC, Kirsten rat sarcoma wild-type (KRAS WT) at initial diagnosis
- Acquired resistance to marketed anti-EGFR mAbs as defined in the protocol
- Written informed consent obtained before undergoing any study-related activities
- Measurable disease defined as one or more target lesions according to RECIST
- Male or female, at least 18 years of age
- Other protocol defined inclusion criteria could apply
- Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 1
- Life expectancy of at least 3 months
- Failure of or intolerance to 5-FU, Oxaliplatin, and Irinotecan
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)
- Other protocol defined exclusion criteria could apply
- Known hypersensitivity to any of the treatment ingredients. Known previous Grade 3-4 infusion related reactions with anti-EGFR mABs
- ...
- 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)
- Other protocol defined exclusion criteria could apply
- Known hypersensitivity to any of the treatment ingredients. Known previous Grade 3-4 infusion related reactions with anti-EGFR mABs
- Magnesium less than 0.9 milligram per deciliter (mg/dL)
- Skin rash Common Terminology Criteria for AEs (CTCAE) Grade greater than 1 from previous anti-EGFR therapy at time of randomization
- Pretreatment with regorafenib.
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
- Subjects with histologically or cytologically confirmed mCRC, Kirsten rat sarcoma wild-type (KRAS WT) at initial diagnosis
- Acquired resistance to marketed anti-EGFR mAbs as defined in the protocol
- Written informed consent obtained before undergoing any study-related activities
- ...
- Subjects with histologically or cytologically confirmed mCRC, Kirsten rat sarcoma wild-type (KRAS WT) at initial diagnosis
- Acquired resistance to marketed anti-EGFR mAbs as defined in the protocol
- Written informed consent obtained before undergoing any study-related activities
- Measurable disease defined as one or more target lesions according to RECIST
- Male or female, at least 18 years of age
- Other protocol defined inclusion criteria could apply
- Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 1
- Life expectancy of at least 3 months
- Failure of or intolerance to 5-FU, Oxaliplatin, and Irinotecan
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)
- Other protocol defined exclusion criteria could apply
- Known hypersensitivity to any of the treatment ingredients. Known previous Grade 3-4 infusion related reactions with anti-EGFR mABs
- ...
- 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)
- Other protocol defined exclusion criteria could apply
- Known hypersensitivity to any of the treatment ingredients. Known previous Grade 3-4 infusion related reactions with anti-EGFR mABs
- Magnesium less than 0.9 milligram per deciliter (mg/dL)
- Skin rash Common Terminology Criteria for AEs (CTCAE) Grade greater than 1 from previous anti-EGFR therapy at time of randomization
- Pretreatment with regorafenib.
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