A Phase 3 interventional study of Regorafenib (Stivarga, BAY73- 4506) in Colorectal Neoplasms, sponsored by Bayer. Completed at 11 sites in Turkey. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-04-22.
Sponsored by Bayer · Phase 3, Interventional, and Treatment
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.
5,598 studies on the registry are indexed under Colorectal Neoplasms; 1,458 are open to participants now.
This study's enrollment of 100 is above the median of 77 across 4,122 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.
Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Regorafenib, 40 mg tablets
Drug: Regorafenib (Stivarga, 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)
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)
The PFS is defined as the time from date of treatment assignment (i.e., date of first treatment) to date of first observed disease progression or death due to any cause, if death occurs while the subject is in the study (that is, by the last visit including during the safety follow-up visit date), and before progression is observed.
Time frame: Up to 6 months
This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Bayer