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Efavirenz in Treating Patients With Metastatic Prostate Cancer

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ClinicalTrials.gov Identifier: NCT00964002
Recruitment Status : Unknown
Verified September 2009 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : August 24, 2009
Last Update Posted : September 7, 2009
Sponsor:
Information provided by:
National Cancer Institute (NCI)

August 21, 2009
August 24, 2009
September 7, 2009
May 2008
December 2009   (Final data collection date for primary outcome measure)
Non-PSA progression rate at 3 months
Same as current
Complete list of historical versions of study NCT00964002 on ClinicalTrials.gov Archive Site
  • PSA response rate at 3 months
  • Overall survival
  • PSA progression-free survival (PFS)
  • Symptomatic PFS
  • LINE 1 methylation level at baseline and 3 months
  • Efavirenz blood concentration at 1 and 3 months
  • Safety and tolerability as assessed by the incidence and type of adverse events according to NCI CTCAE, clinically significant laboratory abnormalities, and vital signs
Same as current
Not Provided
Not Provided
 
Efavirenz in Treating Patients With Metastatic Prostate Cancer
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.

OBJECTIVES:

Primary

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

Secondary

  • To assess the effect of efavirenz on the PSA response at 3 months.
  • To assess the effect of efavirenz on overall survival.
  • To assess the effect of efavirenz on PSA progression-free survival.
  • To assess the effect of efavirenz on symptomatic 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.

Interventional
Phase 2
Masking: None (Open Label)
Primary Purpose: Treatment
Prostate Cancer
Drug: efavirenz
Not Provided
Houédé N, Pulido M, Mourey L, Joly F, Ferrero JM, Bellera C, Priou F, Lalet C, Laroche-Clary A, Raffin MC, Ichas F, Puech A, Piazza PV. A phase II trial evaluating the efficacy and safety of efavirenz in metastatic castration-resistant prostate cancer. Oncologist. 2014 Dec;19(12):1227-8. doi: 10.1634/theoncologist.2014-0345. Epub 2014 Oct 29.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
60
Same as current
Not Provided
December 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT00964002
CDR0000641767
IB-FAVE
IB 2008-23
INCA-RECF0889
EUDRACT-2008-002730-30
Not Provided
Not Provided
Not Provided
Not Provided
Institut Bergonié
Not Provided
Principal Investigator: Nadine Houede Institut Bergonié
National Cancer Institute (NCI)
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP