Efavirenz in Treating Patients With Metastatic Prostate Cancer
|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
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.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: efavirenz||Phase 2|
- To assess the effect of efavirenz on the non-PSA progression rate at 3 months in patients with castration-refractory metastatic prostate cancer.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial to Assess the Efficacy of Efavirenz in Metastatic Patients With Androgen-independent Prostate Cancer|
|Study Start Date :||May 2008|
|Estimated Primary Completion Date :||December 2009|
- Non-PSA progression rate at 3 months
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00964002
|Bordeaux, France, 33076|
|Contact: Nadine Houede 33-556-333-333 firstname.lastname@example.org|
|Principal Investigator:||Nadine Houede||Institut Bergonié|