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

Primary Purpose

Advanced Hepatocarcinoma

Status

Completed

Phase

Phase 2

Locations

Spain

Study Type

Interventional

Intervention

Pravastatin

About this trial

This is an interventional treatment trial for Advanced Hepatocarcinoma

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Hospital Donostia, Instituto Biodonostia

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Sorafenib plus Pravastatin

Sorafenib plus Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Overall survival

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

Secondary Outcome Measures

Time to progression

To evaluate the time to progression (TTP).

time to symptomatic progression (TTSP).

To evaluate the time to symptomatic progression (TTSP).

Full Information

NCT ID

NCT01418729

First Posted

August 15, 2011

Last Updated

September 19, 2017

Sponsor

Hospital Donostia

Collaborators

INSTITUTO BIODONOSTIA

1. Study Identification

Unique Protocol Identification Number

NCT01418729

Brief Title

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

Acronym

ESTAHEP-2010

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 Type

Interventional

2. Study Status

Record Verification Date

September 2017

Overall Recruitment Status

Completed

Study Start Date

September 2011 (undefined)

Primary Completion Date

December 2015 (Actual)

Study Completion Date

June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hospital Donostia

Collaborators

INSTITUTO BIODONOSTIA

4. Oversight

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Advanced Hepatocarcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

216 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sorafenib plus Pravastatin

Arm Type

Active Comparator

Arm Description

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

Arm Title

Sorafenib plus Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Pravastatin

Intervention Description

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.

Primary Outcome Measure Information:

Title

Overall survival

Description

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

Time Frame

18 months

Secondary Outcome Measure Information:

Title

Time to progression

Description

To evaluate the time to progression (TTP).

Time Frame

18 months

Title

time to symptomatic progression (TTSP).

Description

To evaluate the time to symptomatic progression (TTSP).

Time Frame

18 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

100 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials: