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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-024421-21 | EudraCT Number |
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| Name | Class |
|---|---|
| INSTITUTO BIODONOSTIA | UNKNOWN |
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The purpose of this study is to evaluate the overall survival (OS) in order to assess the efficacy and safety of pravastatin as adjuvant treatment to sorafenib.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sorafenib plus Pravastatin | Active Comparator | The treatment received will be sorafenib 400 mg/12 h + pravastatin 40 mg/24 h. |
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| Sorafenib plus Placebo | Placebo Comparator | The treatment received will be sorafenib 400 mg/12 h + placebo/24 h. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pravastatin | Drug | Treatment: Patients will be randomized in two groups, A and B:
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| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | To evaluate the overall survival (OS) in order to assess the efficacy and safety of pravastatin as adjuvant treatment to sorafenib. | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Time to progression | To evaluate the time to progression (TTP). | 18 months |
| time to symptomatic progression (TTSP). | To evaluate the time to symptomatic progression (TTSP). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Juan I Arenas, MD,PHD | Hospital Donostia | Study Chair |
| Javier Bustamante Scheneider, MD | Hospital de Cruces | Principal Investigator |
| Trinidad Serrano Aullo, MD, PHD | Hospital ClÃnico Universitario Lozano Blesa | Principal Investigator |
| Mercedes Iñarrairaegui Bastarrica, MD | ClÃnica Universitaria de Navarra | Principal Investigator |
| Sonia Blanco Sampascual, MD | Hospital de Basurto | Principal Investigator |
| Maria Varela, MD, PHD | Hospital Central de Asturias | Principal Investigator |
| Oscar Nuñez, MD | Hospital Infanta Sofia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Donostia, Instituto Biodonostia | Donostia / San Sebastian | Gipuzkoa | 20014 | Spain |
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| Label | URL |
|---|---|
| Related Info | View source |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 12, 2021 | |
| Reset | Feb 2, 2021 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 12, 2021 | Feb 2, 2021 |
| ID | Term |
|---|---|
| D017035 | Pravastatin |
| ID | Term |
|---|---|
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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|
| 18 months |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |