Recruitment

Recruitment Status
Completed
Estimated Enrollment
240

Inclusion Criteria

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

Exclusion Criteria

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

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

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

Exclusion Criteria

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

Locations

Avignon, 84000
Warszawa, 02-781
Henderson, Nevada, 89074
Gent, 9000
Lyon, 69008
...
Avignon, 84000
Warszawa, 02-781
Henderson, Nevada, 89074
Gent, 9000
Lyon, 69008
Olsztyn, 10-228
Pisa, 56126
Terni, 05100
Barcelona, 08035
Wien, 1100
Genova, 16132
Angers Cedex 9, 49933
Madrid, 28050
Napoli, 80138
Dijon Cedex, 21079
Dresden, 01307
Milano, 20162
Ancona, 60126
Miskolc, 3526
Leuven, 3000
Namur, 5000
Poznan, 61-866
Budapest, 1145
Mons, 7000
Bruxelles, 1200
Barcelona, 08036
Rennes Cedex, 35042
Saint Herblain, 44805
Saint Petersburg, Florida, 33705
Nyiregyhaza, 4400
Yvoir, 5530
Toulouse Cedex 9, 31059
Padova, 35128
Bordeaux Cedex, 33075
Springfield, Missouri, 65807
Tyler, Texas, 75702
Saint Louis, Missouri, 63110
Sevilla, 41013
San Diego, California, 92123
Port Saint Lucie, Florida, 34952
Szolnok, 5000
Madrid, 28007
Oviedo, 33006
Fort Myers, Florida, 33916
Sora, 03039
Roma, 00168
Frankfurt, 60590
Bruxelles, 1070
Barcelona, 08908
Omsk, 644013
St. Petersburg, 197022
Torun, 87-100
Barcelona, 08003
Los Angeles, California, 90033

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