Sym004 vs Standard of Care in Subjects With Metastatic Colorectal Cancer



Status:Completed
Conditions:Colorectal Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:12/26/2018
Start Date:March 6, 2014
End Date:April 26, 2017

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Open-label, Randomized, Controlled, Multicenter Phase II Trial Investigating 2 Sym004 Doses Versus Investigator`s Choice (Best Supportive Care, Capecitabine, 5-FU) in Subjects With Metastatic Colorectal Cancer and Acquired Resistance to Anti-EGFR Monoclonal Antibodies

This is a Phase 2, open-label, randomized, 3-arm trial investigating the safety and effect of
two Sym004 doses (Arm A and Arm B) compared with a control group (Arm C) in subjects with
metastatic colorectal cancer (mCRC) and acquired resistance to anti-epidermal growth factor
receptor (EGFR) monoclonal antibodies (mAbs).

This trial assesses the efficacy of 2 different weekly dosing regimens of Sym004 (Arm A: 9
mg/kg loading dose followed by 6 mg/kg/week dose versus Arm B: 12 mg/kg/week) compared with
investigator's choice in terms of overall survival time in subjects with mCRC. Subjects
assigned to investigator's choice (Arm C) will receive: best supportive care (BSC), or
Fluorouracil (5-FU), or capecitabine, per local standard of care.

The subject will receive weekly Sym004 administration by intravenous (IV) infusion from Week
1 until unacceptable toxicity, disease progression, or consent withdrawal occurs, 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:

- 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, Kirsten rat sarcoma
wild-type (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 RECIST

- Life expectancy of at least 3 months

- Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 1

- Other protocol defined inclusion criteria could apply

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 AEs (CTCAE) Grade greater than 1 from
previous anti-EGFR therapy at time of randomization

- Magnesium less than 0.9 milligram per deciliter (mg/dL)

- 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
We found this trial at
10
sites
1441 Eastlake Ave
Los Angeles, California 90033
(323) 865-3000
U.S.C./Norris Comprehensive Cancer Center The USC Norris Comprehensive Cancer Center, located in Los Angeles, is...
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1871 SE Tiffany Ave # 100
Port Saint Lucie, Florida 34952
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Fort Myers, Florida 33905
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Fort Myers, FL
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Henderson, NV
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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Saint Louis, MO
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Saint Petersburg, Florida 33705
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Saint Petersburg, FL
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7901 Frost Street
San Diego, California 92123
858-939-3400
Sharp Memorial Hospital Sharp Memorial Hospital offers clinical excellence with the latest technology and patient-centered...
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San Diego, CA
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Springfield, Missouri 65806
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Springfield, MO
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Tyler, Texas 75702
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Tyler, TX
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3 Kundratstraße
Wien, 1100
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Wien,
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