Efficacy and Safety Study of Sorafenib Plus Pravastatin to Treat Advanced Hepatocarcinoma

NCT01418729 | Completed Phase 2 DMC

• 2 other identifiers: ESTAHEP-20102010-024421-21
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Advanced Hepatocarcinoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Time to progression

  18 months

• time to symptomatic progression (TTSP).

  18 months

Study Arms (2)

Sorafenib plus Pravastatin

ACTIVE COMPARATOR

The treatment received will be sorafenib 400 mg/12 h + pravastatin 40 mg/24 h.

Drug: Pravastatin

Sorafenib plus Placebo

PLACEBO COMPARATOR

The treatment received will be sorafenib 400 mg/12 h + placebo/24 h.

Drug: Pravastatin

Interventions

Pravastatin DRUG

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; Sorafenib plus Pravastatin

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Donostia: lead
• INSTITUTO BIODONOSTIA: collaborator

Study Sites (1)

Hospital Donostia, Instituto Biodonostia

Donostia / San Sebastian, Gipuzkoa, 20014, Spain

Location

Related Links

• Related Info

MeSH Terms

Interventions

Pravastatin

Intervention Hierarchy (Ancestors)

Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Juan I Arenas, MD,PHD

  Hospital Donostia

  STUDY CHAIR

• Javier Bustamante Scheneider, MD

  Hospital de Cruces

  PRINCIPAL INVESTIGATOR

• Trinidad Serrano Aullo, MD, PHD

  Hospital Clínico Universitario Lozano Blesa

  PRINCIPAL INVESTIGATOR

• Mercedes Iñarrairaegui Bastarrica, MD

  Clínica 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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD. PHD

Study Record Dates

• First Submitted: August 15, 2011
• First Posted: August 17, 2011
• Study Start: September 1, 2011
• Primary Completion: December 1, 2015
• Study Completion: June 1, 2017
• Last Updated: September 20, 2017

Record last verified: 2017-09

Locations

ES (1)