Sym004 vs Standard of Care in Subjects With Metastatic Colorectal Cancer

Completed · Phase 2

Conditions studied: Metastatic Colorectal Cancer

In brief

This is a Phase 2, open-label, randomized, 3-arm trial investigating the efficacy 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).

Key facts

Study ID

NCT02083653

Run by

Symphogen A/S

People needed

254

Starts

2014-03-06

Expected to finish

2017-04-26

Last updated by the study team

2019-04-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Sharp Memorial Hospital — San Diego, California, United States
• Florida Cancer Specialists-Broadway — Fort Myers, Florida, United States
• Hematology - Oncology Associates of Treasure Coast — Port Saint Lucie, Florida, United States
• Florida Cancer Specialists — St. Petersburg, Florida, United States
• Mercy Research — Springfield, Missouri, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Comprehensive Cancer Centers of Nevada — Henderson, Nevada, United States
• Texas Oncology, P.A. — Tyler, Texas, United States
• SMZ Süd - Kaiser Franz Josef Spital Wien — Vienna, Austria
• ULB Hôpital Erasme — Brussels, Belgium
• Cliniques Universitaires Saint-Luc — Brussels, Belgium
• Universitair Ziekenhuis Gent — Ghent, Belgium
• UZ Leuven — Leuven, Belgium
• CHU Ambroise Paré — Mons, Belgium
• Clinique et Maternité Sainte-Elisabeth — Namur, Belgium
• CHU Mont-Godinne — Yvoir, Belgium
• ICO - Site Paul Papin — Angers, France
• Institut Sainte Catherine — Avignon, France
• Groupe Hospitalier Saint André - Hôpital Saint André — Bordeaux, France
• Centre Georges François Leclerc — Dijon, France
• Centre Léon Bérard — Lyon, France
• CRLCC Eugene Marquis — Rennes, France
• ICO - Site René Gauducheau — Saint-Herblain, France
• CHU de Toulouse - Hôpital Rangueil — Toulouse, France
• USC Norris Comprehensive Cancer Center — Los Angeles, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.