Status:
COMPLETED
Study to Determine Safety, Pharmacokinetics, Pharmacodynamics of BAY73-4506 in Combination With mFOLFOX6 or FOLFIRI
Lead Sponsor:
Bayer
Conditions:
Colorectal Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 treatmen...
Eligibility Criteria
Inclusion
- Histological or cytological documentation of adenocarcinoma of the colon or rectum.
- At least 1 measurable lesion as per RECIST
- ECOG Performance Status of 0 - 1
- Life expectancy of at least 12 weeks.
- Adequate bone marrow, liver, and renal function
Exclusion
- More than 1 previous chemotherapy for Colorectal Cancer. Adjuvant chemotherapy for Colorectal Cancer (Stage I, II, II) is permitted, if the adjuvant therapy ended \>6 month before screening.
- Previous FOLFOX treatment for patients who will be included in the mFOLFOX6 cohort apart from FOLFOX treatment in an adjuvant setting.
- Previous FOLFIRI treatment for patients who will be included in the FOLFIRI cohort.
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00934882
Start Date
August 1 2009
End Date
April 1 2012
Last Update
June 2 2014
Active Locations (7)
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1
Freiburg im Breisgau, Baden-Wurttemberg, Germany, 79106
2
Heidelberg, Baden-Wurttemberg, Germany, 69120
3
Mannheim, Baden-Wurttemberg, Germany, 68167
4
Oldenburg, Lower Saxony, Germany, 26133