Study to Determine Safety, Pharmacokinetics, Pharmacodynamics of BAY73-4506 in Combination With mFOLFOX6 or FOLFIRI
Status:
Completed
Trial end date:
2012-04-01
Target enrollment:
Participant gender:
Summary
This multi-center, open-label, non-randomized, non-placebo-controlled, Phase I study will
define the safety profile and tumor response profile of the multi-kinase inhibitor BAY73-4506
as oral treatment in combination with the chemotherapy regimen mFOLFOX6 or FOLFIRI in
patients with metastatic CRC. It will also determine the impact of the combined
administration on the concentration of drugs over time (pharmacokinetics) of BAY73-4506,
oxaliplatin, 5 FU, and irinotecan.
This study will be conducted at approximately 5 - 8 study centers in Germany. Up to 60
patients will be enrolled into this study to ensute that at least 12 - 15 patients for each
combination regimen can be evaluated for safety and pharmacokinetics. For this reason a
minimum of 20 patients will receive mFOLFOX6 in combination with BAY73-4506 and at least 20
patients will receive FOLFIRI in combination with BAY73-4506.