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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-012570-13 | EudraCT Number |
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The purpose of this study is to determine whether BAY73-4506 treatment is safe and can shrink or delay the growth of tumors in patients with unresectable liver cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BAY73-4506 | Drug | 160 mg BAY73-4506 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Event Collection | Up to 30+/- 7 days after permanently discontinuing BAY73-4506 administration |
| Measure | Description | Time Frame |
|---|---|---|
| Time to progression | Every 6 weeks during treatment and after 6 cycle treatment every 18 weeks till progression | |
| Objective response rate | Every 6 weeks during treatmen and after 6 cycle treatment every 18 weeks till progression |
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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 |
|---|---|---|---|---|---|---|
| Regensburg | Bavaria | 93042 | Germany | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23809766 | Result | Bruix J, Tak WY, Gasbarrini A, Santoro A, Colombo M, Lim HY, Mazzaferro V, Wiest R, Reig M, Wagner A, Bolondi L. Regorafenib as second-line therapy for intermediate or advanced hepatocellular carcinoma: multicentre, open-label, phase II safety study. Eur J Cancer. 2013 Nov;49(16):3412-9. doi: 10.1016/j.ejca.2013.05.028. Epub 2013 Jun 25. |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C559147 | regorafenib |
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| Disease control rate | Every 6 weeks during treatmen and after 6 cycle treatment every 18 weeks till progression |
| Overall survival | Every 6 weeks during treatmen and after 6 cycle treatment every 18 weeks till progression |
| Trough concentration of Regorafenib and metabolites (for Europe only) | Cycle 1 Day 15 and Cycle 2 Day 1 |
| Full Pharmacokinetics profile of BAY73-4506 and metabolites (for Korea only) | Cycle 1 Day 21 to Day 28 |
| Frankfurt am Main |
| Hesse |
| 60590 |
| Germany |
| Essen | North Rhine-Westphalia | 45122 | Germany |
| Mainz | Rhineland-Palatinate | 55131 | Germany |
| Magdeburg | Saxony-Anhalt | 39112 | Germany |
| Rozzano | Milano | 20089 | Italy |
| Bologna | 40138 | Italy |
| Milan | 20122 | Italy |
| Milan | 20133 | Italy |
| Roma | 00168 | Italy |
| Daegu | 700-721 | South Korea |
| Seoul | 135-710 | South Korea |
| Barcelona | Barcelona | 08036 | Spain |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |