Advanced HepatocarcinomaPhase 2ESTAHEP-2010NCT01418729
Efficacy and Safety Study of Sorafenib Plus Pravastatin to Treat Advanced Hepatocarcinoma
A Phase 2 study testing Pravastatin in people with Advanced Hepatocarcinoma, run by Hospital Donostia at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Advanced Hepatocarcinoma
- What is being tested?
- Pravastatin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 216 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2011to Jun 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Donostia, Instituto Biodonostia
Donostia / San Sebastian, Gipuzkoa, 20014
About this study
Official 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
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.
- Conditions
- Advanced Hepatocarcinoma
- Being tested
- Pravastatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PravastatinDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Sorafenib plus Pravastatin | Active comparator | The treatment received will be sorafenib 400 mg/12 h + pravastatin 40 mg/24 h. Receives: Drug: Pravastatin |
| Sorafenib plus Placebo | Placebo comparator | The treatment received will be sorafenib 400 mg/12 h + placebo/24 h. Receives: Drug: Pravastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
To evaluate the overall survival (OS) in order to assess the efficacy and safety of pravastatin as adjuvant treatment to sorafenib.
Measured: 18 months
Secondary outcomes (2)
Time to progression
To evaluate the time to progression (TTP).
Measured: 18 months
time to symptomatic progression (TTSP).
To evaluate the time to symptomatic progression (TTSP).
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2011 (estimated)
- Study startSep 2011
- Primary completionDec 2015
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced HepatocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Donostia
- Sponsor type
- University, hospital or other
- Collaborators
- INSTITUTO BIODONOSTIA
- Responsible party
- Principal investigator, Juan I. Arenas Ruiz-Tapiador, Hospital Donostia
- Investigators
- Juan I Arenas, MD,PHD, Study chair, Hospital DonostiaJavier Bustamante Scheneider, MD, Principal investigator, Hospital de CrucesTrinidad Serrano Aullo, MD, PHD, Principal investigator, Hospital Clínico Universitario Lozano BlesaMercedes Iñarrairaegui Bastarrica, MD, Principal investigator, Clínica Universitaria de NavarraSonia Blanco Sampascual, MD, Principal investigator, Hospital de BasurtoMaria Varela, MD, PHD, Principal investigator, Hospital Central de AsturiasOscar Nuñez, MD, Principal investigator, Hospital Infanta Sofia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01418729
- Sponsor's protocol ID
- ESTAHEP-2010
- Other IDs
- 2010-024421-21
- Acronym
- ESTAHEP-2010
- Status last verified
- Sep 2017
- First submitted
- 15 Aug 2011
- Last updated
- 20 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT01418729
- Acronym / sponsor ID
- ESTAHEP-2010 / ESTAHEP-2010
- Conditions
- Advanced Hepatocarcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- Hospital DonostiaUniversity, hospital or other
- Collaborators
- INSTITUTO BIODONOSTIA
- Study start
- Sep 2011
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 17 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sorafenib plus Pravastatin | Active comparator | Drug: PravastatinThe treatment received will be sorafenib 400 mg/12 h + pravastatin 40 mg/24 h. |
| Sorafenib plus Placebo | Placebo comparator | Drug: PravastatinThe treatment received will be sorafenib 400 mg/12 h + placebo/24 h. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PravastatinTreatment: 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. | Drug | Sorafenib plus Placebo, Sorafenib plus Pravastatin |
Primary outcome
Overall survival
Time frame: 18 months
To evaluate the overall survival (OS) in order to assess the efficacy and safety of pravastatin as adjuvant treatment to sorafenib.
2 secondary outcomes
Time to progression
Time frame: 18 months
time to symptomatic progression (TTSP).
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2017.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan I Arenas, MD,PHD study chair
Hospital Donostia
Javier Bustamante Scheneider, MD principal investigator
Hospital de Cruces
Trinidad Serrano Aullo, MD, PHD principal investigator
Hospital Clínico Universitario Lozano Blesa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pravastatin in people with Advanced Hepatocarcinoma, run by Hospital Donostia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2017.