Efficacy and Safety Study of Sorafenib Plus Pravastatin to Treat Advanced Hepatocarcinoma
NCT ID: NCT01418729
Last Updated: 2017-09-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
216 participants
INTERVENTIONAL
2011-09-30
2017-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Sorafenib plus Pravastatin
The treatment received will be sorafenib 400 mg/12 h + pravastatin 40 mg/24 h.
Pravastatin
Treatment:
Patients will be randomized in two groups, A and B:
* Control Group (A ≡ 1): Patients will receive treatment with sorafenib 400 mg/12 h + placebo/24 h.
* Experimental Group (B ≡ 2): The treatment received will be sorafenib 400 mg/12 h + pravastatin 40 mg/24 h.
Sorafenib plus Placebo
The treatment received will be sorafenib 400 mg/12 h + placebo/24 h.
Pravastatin
Treatment:
Patients will be randomized in two groups, A and B:
* Control Group (A ≡ 1): Patients will receive treatment with sorafenib 400 mg/12 h + placebo/24 h.
* Experimental Group (B ≡ 2): The treatment received will be sorafenib 400 mg/12 h + pravastatin 40 mg/24 h.
Interventions
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Pravastatin
Treatment:
Patients will be randomized in two groups, A and B:
* Control Group (A ≡ 1): Patients will receive treatment with sorafenib 400 mg/12 h + placebo/24 h.
* Experimental Group (B ≡ 2): The treatment received will be sorafenib 400 mg/12 h + pravastatin 40 mg/24 h.
Eligibility Criteria
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Inclusion Criteria
* Males and females, over 18 years of age.
* Patients who have not previously received treatment with sorafenib.
* Have an ECOG ≤ 2.
* Liver function: Child A and B7.
* Life expectancy greater than 12 weeks.
* Adequate kidney function: serum creatinine concentration less than or equal to 1.5 times the upper limit of normal (ULN).
* Sign the written informed consent before starting any procedure, including randomization.
Exclusion Criteria
* Patients with hypersensitivity to statins.
* Pregnant or breastfeeding women.
* Peripheral neuropathy: grade 2 or higher
* Patients who have been diagnosed, within the previous 5 years, with another type of tumor, except for non-melanoma skin cancer, or in situ carcinoma of the cervix or the urinary bladder.
* Patients receiving chemotherapy or radiotherapy for another type of tumor.
* Patients with heart failure greater than NYHA grade II, hypertension that is uncontrolled with medication, uncontrolled arrhythmias or AMI within the previous six months.
* A history of perforation or hemorrhage due to a gastroduodenal ulcus within the last month.
* Greater hemorrhagic diseases.
* Asthmatic patients uncontrolled with medication.
* Any other contraindication associated to the use of statins.
* Physical or psychological inability to participate in the trial.
* Treatment with another investigational drug or participation in another clinical trial within 6 months prior to inclusion in the study.
18 Years
100 Years
ALL
No
Sponsors
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INSTITUTO BIODONOSTIA
UNKNOWN
Hospital Donostia
OTHER
Responsible Party
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Juan I. Arenas Ruiz-Tapiador
MD. PHD
Principal Investigators
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Juan I Arenas, MD,PHD
Role: STUDY_CHAIR
Hospital Donostia
Javier Bustamante Scheneider, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital de Cruces
Trinidad Serrano Aullo, MD, PHD
Role: PRINCIPAL_INVESTIGATOR
Hospital Clínico Universitario Lozano Blesa
Mercedes Iñarrairaegui Bastarrica, MD
Role: PRINCIPAL_INVESTIGATOR
Clínica Universitaria de Navarra
Sonia Blanco Sampascual, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital de Basurto
Maria Varela, MD, PHD
Role: PRINCIPAL_INVESTIGATOR
Hospital Central de Asturias
Oscar Nuñez, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital Infanta Sofia
Locations
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Hospital Donostia, Instituto Biodonostia
Donostia / San Sebastian, Gipuzkoa, Spain
Countries
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Related Links
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Related Info
Other Identifiers
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2010-024421-21
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ESTAHEP-2010
Identifier Type: -
Identifier Source: org_study_id