First Line Treatment of Metastatic Colorectal Cancer With mFOLFOX6 in Combination With Regorafenib
NCT ID: NCT01289821
Last Updated: 2017-03-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
54 participants
INTERVENTIONAL
2011-02-28
2014-06-30
Brief Summary
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The primary endpoint (the most meaningful result to be tracked) of this study is based on the rate of response, i.e. the disease getting smaller. The aim is to show that the therapy of colorectal cancer with mFOLFOX6 in combination with regorafenib improves the response rate observed for the standard therapy only.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Regorafenib + oxaliplatin/folinic acid/5-FU (mFOLFOX6)
On Day 1, participants received 85 mg/m\^2 oxaliplatin as a 2-hour intravenous (IV) infusion and folinic acid (either 400 mg/m\^2 D/L-folinic acid or 200 mg/m\^2 L-folinic acid) as a 2-hour IV infusion. Once the initial infusion was completed, participants received 5-FU 400 mg/m\^2 IV bolus injection immediately followed by a 5-FU 2400 mg/m\^2 IV infusion for 46 hours. The next cycle of mFOLFOX6 was administered on Day 15 to 17. Participants received Regorafenib (Stivarga, BAY73-4506) 160 mg orally (po) once daily (qd) on Days 4 to 10 and Days 18 to 24. One cycle comprised 28 days.
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.
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.
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.
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.
Interventions
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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.
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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* Histological or cytological documentation of adenocarcinoma of the colon or rectum
* Suitable to receive mFOLFOX6 regimen as first line metastatic treatment
* At least 1 measurable lesion as per RECIST version 1.1
* Unresectable or unlikely becoming resectable metastatic disease
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
* Life expectancy of at least 3 months
* Adequate bone marrow, liver, and renal function
Exclusion Criteria
* Prior treatment with antivascular endothelial growth factor (anti-VEGF) agents and any signal transduction inhibitors (STIs)
* Uncontrolled hypertension
* Subjects with symptoms, signs, or history of brain metastases
* Any hemorrhage or bleeding event ≥ Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 within 4 weeks of start of study treatment
* Sensory neuropathy (\> CTCAE Grade 1), unresolved toxicity \> CTCAE Grade 1 attributed to any prior therapy/procedure excluding alopecia
18 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Chicago, Illinois, United States
Concord, New South Wales, Australia
Woodville South, South Australia, Australia
Bruxelles - Brussel, , Belgium
Edegem, , Belgium
Leuven, , Belgium
Stuttgart, Baden-Wurttemberg, Germany
Oldenburg, Lower Saxony, Germany
Herne, North Rhine-Westphalia, Germany
Dresden, Saxony, Germany
Napoli, Campania, Italy
Genoa, Liguria, Italy
Ancona, The Marches, Italy
Barcelona, Barcelona, Spain
Santander, Cantabria, Spain
Madrid, Madrid, Spain
Manchester, Manchester, United Kingdom
Glasgow, , United Kingdom
Countries
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References
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Schultheis B, Folprecht G, Kuhlmann J, Ehrenberg R, Hacker UT, Kohne CH, Kornacker M, Boix O, Lettieri J, Krauss J, Fischer R, Hamann S, Strumberg D, Mross KB. Regorafenib in combination with FOLFOX or FOLFIRI as first- or second-line treatment of colorectal cancer: results of a multicenter, phase Ib study. Ann Oncol. 2013 Jun;24(6):1560-7. doi: 10.1093/annonc/mdt056. Epub 2013 Mar 13.
Related Links
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Click here to find information about studies related to Bayer Healthcare products conducted in Europe
Other Identifiers
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2010-020121-41
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
11728
Identifier Type: -
Identifier Source: org_study_id
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