Advanced Hepatocarcinoma Clinical Trial
— ESTAHEP-2010Official title:
Phase-II, Multicenter, Randomized, Double-Blind, Parallel-Group Trial to Compare the Efficacy and Safety of Sorafenib Plus Pravastatin Against Sorafenib Plus Placebo in Patients With Advanced Hepatocarcinoma
| Verified date | September 2017 |
| Source | Hospital Donostia |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 216 |
| Est. completion date | June 2017 |
| Est. primary completion date | December 2015 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 100 Years |
| Eligibility |
Inclusion Criteria: - Patients who have been diagnosed with advanced hepatocarcinoma (HCC), confirmed histologically or with non-invasive criteria, according to the clinical practice guidelines by the American Association for the Study of Liver Diseases (AASLD) during a maximum period of 15 days prior to the baseline visit. - 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 who routinely (more than 3 times a week) take some sort of statin. - 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. |
| Country | Name | City | State |
|---|---|---|---|
| Spain | Hospital Donostia, Instituto Biodonostia | San Sebastian | Gipuzkoa |
| Lead Sponsor | Collaborator |
|---|---|
| Hospital Donostia | INSTITUTO BIODONOSTIA |
Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Secondary | Time to progression | To evaluate the time to progression (TTP). | 18 months | |
| Secondary | time to symptomatic progression (TTSP). | To evaluate the time to symptomatic progression (TTSP). | 18 months |