EMD 525797- k-ras wild type metastatic colorectal cancer
Research type
Research Study
Full title
An open-label, randomized, controlled, multi-center, Phase I/II trial investigating 2 EMD 525797 doses in combination with cetuximab + irinotecan versus cetuximab + irinotecan alone, as second-line treatment for subjects with k-ras wild type (WT) metastatic colorectal cancer (mCRC). Subjects with k-ras WT mCRC will be eligible for enrollment if they are refractory to or progressive after first-line chemotherapy with an oxaliplatin-containing therapeutic regimen.
IRAS ID
32694
Contact name
Jim Cassidy
Sponsor organisation
Merck KGaA,
Eudract number
2009-012040-16
Clinicaltrials.gov Identifier
Research summary
This trial is being conducted to evaluate a new drug, called EMD 525797, in patients with metastatic colorectal cancer (mCRC) with a specific genetic information in the tumor, which is a gene called k ras wild type, for which previous treatment has stopped being effective. Since 1996, six new agents have been approved for the management of mCRC. However, despite these advances the prognosis for patients with this disease remains poor with a median survival time of approximately 21 months. In addition, colorectal cancer accounts for more than 500,000 deaths per year worldwide. There is therefore a need for innovative approaches and it is hoped that this study will help to determine if EMD 525797 is safe and effective when added to irinotecan and cetuximab as second-line treatment. EMD 525797 is an antibody which has been designed specifically to attach to certain proteins called integrin receptors, which are present on some cancer cells and blood vessels. By binding to these integrin receptors, it is hoped that EMD 525797 will prevent the growth and spread of cancers and their blood supply, and even destroy the cancer cells. Approximately 213 subjects will take part in approximately 55 hospitals in Europe. Patients, with their consent, will be tested for the wild type k-ras gene. If they are found to have this gene they will be randomised to one of 3 groups on a 1:1:1 ratio. Group A will receive the Trial Drug at a dose of 250 mg in addition to treatment with cetuximab and irinotecan; Group B will receive the Trial Drug at a maximum dose of 1,000 mg in addition to treatment with cetuximab and irinotecan; Group C will only receive treatment with cetuximab and irinotecan. The trial is estimated to be approximately 33 months. This study is sponsored by Merck KGaA.
REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
10/H0906/5
Date of REC Opinion
7 Apr 2010
REC opinion
Further Information Favourable Opinion