Woman and Man
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Extract
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).
Inclusion criteria
- 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