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ESTAHEP-2010: Efficacy and Safety Study of Sorafenib Plus Pravastatin to Treat Advanced Hepatocarcinoma

Sponsor
Hospital Donostia (Other)
Overall Status
Completed
CT.gov ID
NCT01418729
Collaborator
INSTITUTO BIODONOSTIA (Other)
216
Enrollment
1
Location
2
Arms
69
Duration (Months)
3.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
216 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Study Start Date :
Sep 1, 2011
Actual Primary Completion Date :
Dec 1, 2015
Actual Study Completion Date :
Jun 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Sorafenib plus Pravastatin

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

Drug: 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.
Placebo Comparator: Sorafenib plus Placebo

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

Drug: 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.

Outcome Measures

Primary Outcome Measures

  1. Overall survival [18 months]

    To evaluate the overall survival (OS) in order to assess the efficacy and safety of pravastatin as adjuvant treatment to sorafenib.

Secondary Outcome Measures

  1. Time to progression [18 months]

    To evaluate the time to progression (TTP).

  2. time to symptomatic progression (TTSP). [18 months]

    To evaluate the time to symptomatic progression (TTSP).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital Donostia, Instituto Biodonostia San Sebastian Gipuzkoa Spain 20014

Sponsors and Collaborators

  • Hospital Donostia
  • INSTITUTO BIODONOSTIA

Investigators

  • Study Chair: Juan I Arenas, MD,PHD, Hospital Donostia
  • Principal Investigator: 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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Juan I. Arenas Ruiz-Tapiador, MD. PHD, Hospital Donostia
ClinicalTrials.gov Identifier:
NCT01418729
Other Study ID Numbers:
  • ESTAHEP-2010
  • 2010-024421-21
First Posted:
Aug 17, 2011
Last Update Posted:
Sep 20, 2017
Last Verified:
Sep 1, 2017
Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Pravastatin

Study Results

No Results Posted as of Sep 20, 2017