Study to Determine Safety, Pharmacokinetics, Pharmacodynamics of BAY73-4506 in Combination With mFOLFOX6 or FOLFIRI

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00934882
First received: July 3, 2009
Last updated: May 30, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Colorectal Neoplasms
Drug: Regorafenib (BAY73-4506)
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Adverse Event Collection [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Effect of BAY73-4506 on the pharmacokinetics of mFOLFOX6 and FOLFIRI (Cmax, AUC, through concentration of BAY73-4506 and Cmax, AUC of Platinum, Irinotecan and its metabolite SN-38, 5-Flourouracil) [ Time Frame: Cycle 1 and Cycle 2 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Biomarker status [ Time Frame: Screening, Cycle 1, Cycle 2, Cycle 3 ] [ Designated as safety issue: No ]
  • Pharmacodynamic parameters [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Tumor response [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Enrollment: 45
Study Start Date: August 2009
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Regorafenib (BAY73-4506)
Administration of the multi-kinase inhibitor BAY73-4506 (160 mg once daily from Day 4 to Day 10 and from Day 18 to Day 24) as oral treatment in combination with the chemotherapy regimen mFOLFOX6 or FOLFIRI in patients with metastatic Colorectal Cancer

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00934882

Locations
Germany
Freiburg, Baden-Württemberg, Germany, 79106
Heidelberg, Baden-Württemberg, Germany, 69120
Mannheim, Baden-Württemberg, Germany, 68167
Oldenburg, Niedersachsen, Germany, 26133
Herne, Nordrhein-Westfalen, Germany, 44625
Köln, Nordrhein-Westfalen, Germany, 50937
Dresden, Sachsen, Germany, 01307
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Publications:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00934882     History of Changes
Other Study ID Numbers: 11656, 2008-007151-27
Study First Received: July 3, 2009
Last Updated: May 30, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Bayer:
Colorectal cancer
Targeted therapy
Multi-kinase inhibitor
FOLFOX
FOLFIRI

Additional relevant MeSH terms:
Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on July 29, 2014