Phase I, Open-label, Non-placebo Controlled Study to Determine the Safety, Pharmacokinetics, and Pharmacodynamics of BAY73-4506 in Combination With mFOLFOX6 or FOLFIRI as First or Second Line Therapy in Patients With Metastatic Colorectal.
Phase 1
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Colorectal Neoplasms
Both
Colorectal Neoplasms
Trial Information
Phase I, Open-label, Non-placebo Controlled Study to Determine the Safety, Pharmacokinetics, and Pharmacodynamics of BAY73-4506 in Combination With mFOLFOX6 or FOLFIRI as First or Second Line Therapy in Patients With Metastatic Colorectal.
Inclusion Criteria:
- 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 Criteria:
- 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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Adverse Event Collection
Outcome Time Frame:
3 years
Safety Issue:
Yes
Principal Investigator
Bayer Study Director
Investigator Role:
Study Director
Investigator Affiliation:
Bayer
Authority:
Germany: Federal Institute for Drugs and Medical Devices
Study ID:
11656
NCT ID:
NCT00934882
Start Date:
August 2009
Completion Date:
April 2012
Related Keywords:
- Colorectal Neoplasms
- Colorectal cancer
- Targeted therapy
- Multi-kinase inhibitor
- FOLFOX
- FOLFIRI
- Neoplasms
- Colorectal Neoplasms
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