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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Regorafenib | Experimental | Regorafenib, 40 mg tablets |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Regorafenib (Stivarga, BAY73- 4506) | Drug | 160 mg regorafenib per oral every day for 3 weeks of every 4 week cycle (i.e., 3 weeks on, 1 week off) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events as a measure of safety and tolerability | Up to 6 months | |
| Number of participants with adverse events which caused withdrawal, dose reduction, interruption or discontinuation | Up to 6 months | |
| Number of death | Up to 6 months | |
| Number of participants with serious adverse events as a measure of safety and tolerability | 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. | Up to 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ankara | 06100 | Turkey (Türkiye) | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32220908 | Derived | Dane F, Ozgurdal K, Yalcin S, Benekli M, Aykan NF, Yucel I, Ozkan M, Evrensel T, Sevinc A, Coskun HS, Sanli UA, Kara IO, Yumuk PF. Safety and efficacy of regorafenib in patients with treatment-refractory metastatic colorectal cancer in Turkey: the single-arm, open-label REGARD study. BMJ Open. 2020 Mar 26;10(3):e027665. doi: 10.1136/bmjopen-2018-027665. |
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| Ankara |
| 06500 |
| Turkey (Türkiye) |
| Antalya | Turkey (Türkiye) |
| Balcali/Adana | 01330 | Turkey (Türkiye) |
| Bursa | Turkey (Türkiye) |
| Gaziantep | 27010 | Turkey (Türkiye) |
| Istanbul | 34093 | Turkey (Türkiye) |
| Istanbul | 34899 | Turkey (Türkiye) |
| Izmir | 35100 | Turkey (Türkiye) |
| Kayseri | Turkey (Türkiye) |
| Samsun | Turkey (Türkiye) |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| C559147 | regorafenib |
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