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