Recruitment

Recruitment Status
Completed
Estimated Enrollment
240

Inclusion Criterias

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

Exclusion Criterias

Skin rash Common Terminology Criteria for AEs (CTCAE) Grade greater than 1 from previous anti-EGFR therapy at time of randomization
Pretreatment with regorafenib.
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.
Magnesium less than 0.9 milligram per deciliter (mg/dL)
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)

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 Criterias

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

Exclusion Criterias

Skin rash Common Terminology Criteria for AEs (CTCAE) Grade greater than 1 from previous anti-EGFR therapy at time of randomization
Pretreatment with regorafenib.
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.
Magnesium less than 0.9 milligram per deciliter (mg/dL)
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)

Locations

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

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