This trial is active, not recruiting.

Condition colorectal neoplasms
Treatment regorafenib (bay73- 4506)
Phase phase 3
Sponsor Bayer
Start date July 2013
End date April 2015
Trial size 100 participants
Trial identifier NCT01853319, 16754


This is an open-label phase III study of regorafenib in patients with metastatic colorectal cancer (mCRC) who have progressed after all approved standard therapy. The purpose of this study is to provide additional information about the safety profile of Regorafenib.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Regorafenib, 40 mg tablets
regorafenib (bay73- 4506)
160 mg regorafenib per oral every day for 3 weeks of every 4 week cycle (i.e., 3 weeks on, 1 week off)

Primary Outcomes

Number of participants with adverse events as a measure of safety and tolerability
time frame: Up to 6 months
Number of participants with adverse events which caused withdrawal, dose reduction, interruption or discontinuation
time frame: Up to 6 months
Number of death
time frame: Up to 6 months
Number of participants with serious adverse events as a measure of safety and tolerability
time frame: Up to 6 months
Progression-Free Survival (PFS)
time frame: Up to 6 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Male or female subjects >/= 18 years of age - Life expectancy of at least 3 months - Histological or cytological documentation of adenocarcinoma of the colon or rectum - Subjects with metastatic colorectal cancer (Stage IV) - Progression during or within 3 months following the last administration of approved standard therapies which must include fluoropyrimidine, oxaliplatin, irinotecan, bevacizumab and cetuximab/panitumumab if KRAS WT (WT: wild-type i.e. no KRAS mutation) - Eastern Cooperative Oncology Group (ECOG) Performance Status of /= New York Heart Association (NYHA) class 2 - Myocardial infarction less than 6 months before start of study drug - Ongoing infection > Grade 2 Common Terminology Criteria for Adverse Events (CTCAE) v. 4.0 - Renal failure requiring hemo-or peritoneal dialysis

Additional Information

Official title An Open-label Phase III Study of Regorafenib in Patients With Metastatic Colorectal Cancer (mCRC) Who Have Progressed After Standard Therapy
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Bayer.