Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-26 @ 3:00 AM
Study NCT ID:
NCT00964002
Status:
COMPLETED
Last Update Posted:
2022-05-16
First Post:
2009-08-21
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Efavirenz in Treating Patients With Metastatic Prostate Cancer
Sponsor:
Institut Bergonié
Organization:
Study Overview
Official Title:
A Phase II Trial to Assess the Efficacy of Efavirenz in Metastatic Patients With Androgen-independent Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2021-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FAVE
Brief Summary:
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.
PURPOSE: This phase II trial is studying how well efavirenz works in treating patients with metastatic prostate cancer.
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: