First Line Treatment of Metastatic Colorectal Cancer With mFOLFOX6 in Combination With Regorafenib

PHASE2CompletedINTERVENTIONAL
Enrollment

54

Participants

Timeline

Start Date

February 28, 2011

Primary Completion Date

March 31, 2012

Study Completion Date

June 30, 2014

Conditions
Colorectal Neoplasms
Interventions
DRUG

Regorafenib (Stivarga, BAY73-4506)

Subjects will receive regorafenib 160 mg od on days 4 to 10 and days 18 to 24 as four 40 mg coprecipitate tablets. In case of administration as a single agent during the study, regorafenib will be administered 160 mg od for 3 weeks on/1 week off. Each cycle consists of 28 days.

DRUG

Oxaliplatin

On day 1 and day 15 of each cycle, participants will receive 85 mg/m\^2 oxaliplatin as a 2 hour i.v. infusion.

DRUG

Folinic acid

On day 1 and day 15 of each cycle, participants will receive folinic acid (either 400 mg/m\^2 D/L-folinic acid or 200 mg/m\^2 L-folinic acid) as a 2 hour i.v. infusion.

DRUG

5-FU (mFOLFOX6)

Participants will receive a 400 mg/m\^2 5 FU i.v. bolus injection immediately followed by a 2400 mg/m\^2 5 FU 46 hour i.v. infusion.

Trial Locations (18)

1070

Bruxelles - Brussel

2139

Concord

2650

Edegem

3000

Leuven

5011

Woodville South

16132

Genoa

26133

Oldenburg

28034

Madrid

39008

Santander

44625

Herne

60126

Ancona

70199

Stuttgart

80131

Napoli

60611-2906

Chicago

01307

Dresden

08035

Barcelona

M20 4BX

Manchester

G12 0YN

Glasgow

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY