Trial Condition(s):

Colorectal Neoplasms

First line treatment of metastatic colorectal cancer with mFOLFOX6 in combination with regorafenib

Bayer Identifier:

11728

ClinicalTrials.gov Identifier:

NCT01289821

EudraCT Number:

2010-020121-41

Study Completed

Trial Purpose

This is a study to evaluate the efficacy (effectiveness) and the safety of regorafenib when given in combination with chemotherapy mFOLFOX6 as first line therapy in patients with metastatic colorectal cancer (CRC). mFOLFOX6 is an approved chemotherapy. Regorafenib is an oral (i.e. taken by mouth) multi-targeted kinase inhibitor. A kinase inhibitor targets certain key proteins that are essential for the survival of the cancer cell. By specifically targeting these proteins, regorafenib may stop cancer growth. The growth of the tumor may be decreased by preventing these specific proteins from functioning.

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.

Inclusion Criteria
- Male or female subjects aged ≥ 18 years
 - 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 systemic anticancer therapy for metastatic colorectal cancer (CRC). Adjuvant chemotherapy for CRC (Stage I, II, III) is permitted, if the adjuvant therapy ended > 6 months before screening and recurrent disease was documented.
 - 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

Trial Summary

Enrollment Goal
54
Trial Dates
black-arrow
Phase
2
Could I receive a placebo?
No
Products
Stivarga (Regorafenib, BAY73-4506)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Oldenburg, Germany, 26133

Status
Completed
 
Locations

Investigative Site

Herne, Germany, 44625

Status
Completed
 
Locations

Investigative Site

Dresden, Germany, 01307

Status
Completed
 
Locations

Investigative Site

Woodville South, Australia, 5011

Status
Completed
 
Locations

Investigative Site

Concord, Australia, 2139

Status
Terminated
 
Locations

Investigative Site

Napoli, Italy, 80131

Status
Completed
 
Locations

Investigative Site

Genova, Italy, 16132

Status
Completed
 
Locations

Investigative Site

Ancona, Italy, 60126

Status
Completed
 
Locations

Investigative Site

Barcelona, Spain, 08035

Status
Completed
 
Locations

Investigative Site

Santander, Spain, 39008

Status
Completed
 
Locations

Investigative Site

LEUVEN, Belgium, 3000

Status
Completed
 
Locations

Investigative Site

BRUXELLES - BRUSSEL, Belgium, 1070

Status
Completed
 
Locations

Investigative Site

EDEGEM, Belgium, 2650

Status
Terminated
 
Locations

Investigative Site

Madrid, Spain, 28034

Status
Completed
 
Locations

Investigative Site

Stuttgart, Germany, 70199

Status
Completed
 
Locations

Investigative Site

Glasgow, United Kingdom, G12 0YN

Status
Completed
 
Locations

Investigative Site

Manchester, United Kingdom, M20 4BX

Status
Completed
 
Locations

Investigative Site

Chicago, United States, 60611-2906

Status
Completed
 

Trial Design