EMD 525797 in combination with Cetuximab and Irinotecan in k-ras Wildtype Metastatic Colorectal Cancer

ABSTRACT: Primary objectives: The primary objectives are: • To characterize the safety and tolerability profile of repeated administration of different EMD 525797 dose levels in combination with cetuximab and irinotecan in subjects with k-ras WT mCRC after failure of first-line therapy with an oxaliplatin-containing regimen (Safety Part); • To assess the anti-cancer activity of 2 EMD 525797 doses in terms progression-free survival time in subjects with k-ras WT mCRC after failure of first-line therapy with an oxaliplatin-containing regimen (Randomized Part). Primary endpoints: Safety Part: • To characterize the safety and tolerability profile of repeated administration of different EMD 525797 dose levels in combination with cetuximab and irinotecan in subjects with k-ras WT mCRC after failure of first-line therapy with an oxaliplatin-containing regimen. Randomized Part: • To assess the anti-cancer activity of 2 EMD 525797 doses in terms of progression-free survival time in subjects with k-ras WT mCRC after failure of first-line therapy with an oxaliplatin-containing regimen.

DISEASE(S): Metastatic Colorectal Cancer,Subjects With K-ras Wt, Metastatic Colorectal Cancer Who Have Failed A Fist Line Chemotherapy With An Oxaliplatin-containing Regimen Will Be Eligible For This Trial.

PROVIDER: 2526396 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR