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

Phase 1

Completed

• Conditions: Colorectal Neoplasms
• Interventions: Drug: Regorafenib (BAY73-4506)

• Registration Number: NCT00934882
• Lead Sponsor: Bayer

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 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2009-07-03
• Study First Submitted QC: 2009-07-07
• Study First Posted: 2009-07-08
• Study Start: 2009-08
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-30
• Last Update Posted: 2014-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	Regorafenib (BAY73-4506)	-

Primary Outcome Measures

Name	Time	Method
Adverse Event Collection	3 years
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)	Cycle 1 and Cycle 2

Secondary Outcome Measures

Name	Time	Method
Biomarker status	Screening, Cycle 1, Cycle 2, Cycle 3
Pharmacodynamic parameters	3 years
Tumor response	3 years