drugset / Trial / NCT02083653
Sym004 vs Standard of Care in Subjects With Metastatic Colorectal Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
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).
Timeline
- Start
- 2014-03-06
- Primary completion
- 2016-10-24
- Completion
- 2017-04-26
Publications
- Background Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993 Mar 3;85(5):365-76. doi: 10.1093/jnci/85.5.365.
- Background Fayers PM, Aaronson NK, Bjordal K, Groenvold M, Curran D, Bottomley A, on behalf of the EORTC Quality of Life Group. The EORTC QLQ-C30 Scoring Manual (3rd Edition). Published by: European Organisation for Research and Treatment of Cancer, Brussels 2001.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Capecitabine | Small molecule | — | — |
| Subject | Futuximab | Monoclonal antibody | 6 mg/kg | Intravenous |
| Subject | Futuximab | Monoclonal antibody | 12 mg/kg | Intravenous |
| Subject | Modotuximab | Monoclonal antibody | 6 mg/kg | Intravenous |
| Subject | Modotuximab | Monoclonal antibody | 12 mg/kg | Intravenous |
| Comparator | fluorouracil | Small molecule | — | — |