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

Sponsor

Bayer (Industry)

Overall Status

Completed

CT.gov ID

NCT00934882

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

6.4

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Neoplasms	Drug: Regorafenib (BAY73-4506)	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

45 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (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.

Study Start Date :

Aug 1, 2009

Actual Primary Completion Date :

Apr 1, 2012

Actual Study Completion Date :

Apr 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

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

Biomarker status [Screening, Cycle 1, Cycle 2, Cycle 3]
Pharmacodynamic parameters [3 years]
Tumor response [3 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	City	State	Country	Postal Code
1	Freiburg	Baden-Württemberg	Germany	79106
2	Heidelberg	Baden-Württemberg	Germany	69120
3	Mannheim	Baden-Württemberg	Germany	68167
4	Oldenburg	Niedersachsen	Germany	26133
5	Herne	Nordrhein-Westfalen	Germany	44625
6	Köln	Nordrhein-Westfalen	Germany	50937
7	Dresden	Sachsen	Germany	01307