Efavirenz in Treating Patients With Metastatic Prostate Cancer (FAVE)

March 1, 2022 updated by: Institut Bergonié

A Phase II Trial to Assess the Efficacy of Efavirenz in Metastatic Patients With Androgen-independent Prostate Cancer

RATIONALE: Efavirenz may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase II trial is studying how well efavirenz works in treating patients with metastatic prostate cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

Primary

  • To assess the effect of efavirenz on the PSA non-progression rate at 3 months in patients with castration-refractory metastatic prostate cancer.

Secondary

  • To assess the effect of efavirenz on the PSA non-progression rate at 6 months.
  • To assess the effect of efavirenz on overall survival.
  • To assess the effect of efavirenz on PSA progression-free survival..
  • To assess the tolerability and safety profile of efavirenz.

OUTLINE: This is a multicenter study.

Patients receive oral efavirenz once daily in the absence of disease progression or unacceptable toxicity.

Study Type

Interventional

Enrollment (Actual)

61

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France, 33076
        • Institut Bergonié

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

DISEASE CHARACTERISTICS:

  • Histologically confirmed prostate cancer

    • Metastatic disease
    • Castration-refractory disease
  • No clinical symptoms related to disease progression

PATIENT CHARACTERISTICS:

  • WHO performance status 0-2

PRIOR CONCURRENT THERAPY:

  • Not specified

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Efavirenz

Patients will receive efavirenz 600 mg daily as oral tablets at bedtime and in fast condition (1-2 hours far from dinner) until objective biological, radiological or clinical disease progression or study discontinuation (withdrawal of consent or when the patient meets one criterion for treatment discontinuation).

Individual dose escalation will be possible: if biological progression occurs at month 3, dose could be increased to 1200 mg/day in asymptomatic and non radiological progression patients (by step of 200 mg every 15 days).
Drug: efavirenz

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Without Prostate-specific Antigen Progression at 3 Months
Time Frame: 3 months

Prostate-specific antigen (PSA) non-progression rate is defined as the rate of patients with the absence of PSA progression.

PSA progression is defined as follows :

  • In patients whose PSA has not decreased, progressive disease is a 25% increase over the baseline (on-study) and an increase in the absolute-value PSA level by at least 5 ng/mL, which is confirmed by a second value.
  • In patients whose PSA has decreased but has not reached response criteria, progressive disease would be considered to have occurred when PSA increases 25% over the nadir, provided that the increase is a minimum of 5 ng/mL and is confirmed.

For the 3-month evaluation, patients who died within the 3 first months will be considered as progressions.

PSA assessment is to be performed every 28 days in the first 6 months after inclusion then every 3 months until progression or end of treatment. PSA assessment to establish eligibility is to be obtained from the same local laboratory using the same PSA assay.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Without Prostate-specific Antigen Progression at 6 Months
Time Frame: 6 months

Prostate-specific antigen (PSA) non-progression rate is defined as the rate of patients with the absence of PSA progression.

PSA progression is defined as follows :

  • In patients whose PSA has not decreased, progressive disease is a 25% increase over the baseline (on-study) and an increase in the absolute-value PSA level by at least 5 ng/mL, which is confirmed by a second value.
  • In patients whose PSA has decreased but has not reached response criteria, progressive disease would be considered to have occurred when PSA increases 25% over the nadir, provided that the increase is a minimum of 5 ng/mL and is confirmed.

For the 6-month evaluation, patients who died within the 6 first months will be considered as progressions.

PSA assessment is to be performed every 28 days in the first 6 months after inclusion then every 3 months until progression or end of treatment. PSA assessment to establish eligibility is to be obtained from the same local laboratory using the same PSA assay.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Bergonié

Investigators

  • Principal Investigator: Nadine Houede, Institut Bergonié

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2008

Primary Completion (Actual)

September 19, 2011

Study Completion (Actual)

April 8, 2014

Study Registration Dates

First Submitted

August 21, 2009

First Submitted That Met QC Criteria

August 21, 2009

First Posted (Estimate)

August 24, 2009

Study Record Updates

Last Update Posted (Actual)

May 16, 2022

Last Update Submitted That Met QC Criteria

March 1, 2022

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000641767
  • IB-FAVE
  • IB 2008-23
  • INCA-RECF0889
  • EUDRACT-2008-002730-30

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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