Ignite Creation Date:
2024-05-05 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003343
Status:
COMPLETED
Last Update Posted:
2012-08-08
First Post:
1999-11-01
Brief Title:
Chemotherapy in Treating Patients Who Have Metastatic Prostate Cancer
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Phase III Study of the Matrix Metalloprotease Inhibitor AG3340 in Combination With Mitoxantrone and Prednisone With Provision for Subsequent Change in Therapy in Patients Having Hormone-Refractory Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2012-08
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:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die It is not yet known whether mitoxantrone and prednisone are more effective with or without prinomastat in treating patients with metastatic prostate cancer
PURPOSE Randomized phase III trial to determine the effectiveness of mitoxantrone and prednisone with or without prinomastat in treating patients who have metastatic prostate cancer that has not responded to hormone therapy
PURPOSE Randomized phase III trial to determine the effectiveness of mitoxantrone and prednisone with or without prinomastat in treating patients who have metastatic prostate cancer that has not responded to hormone therapy
Detailed Description:
OBJECTIVES I Compare symptomatic progression free survival among patients having metastatic hormone refractory prostate cancer receiving one of two doses of matrix metalloprotease inhibitor AG3340 or placebo initially in combination with mitoxantrone and prednisone with provision for subsequent change in therapy II Compare the symptomatic response quality of life serologic PSA response PSA progression free survival radiographic response radiographic progression free survival one year survival and overall survival of these patients III Evaluate the safety of AG3340 in regimen combination and in combination with therapies administered subsequent to first line in this patient population IV Evaluate the population pharmacokinetics of AG3340 when given in this treatment regimen
OUTLINE This is a randomized double blind placebo controlled multicenter study Patients receive the matrix metalloprotease inhibitor AG3340 at one of two dosages or placebo orally twice a day beginning on day 1 Patients receive mitoxantrone by intravenous infusion on day 1 and prednisone orally twice daily beginning on day 1 Treatment course is repeated every 3 weeks in the absence of unacceptable toxicity Mitoxantrone andor prednisone may be discontinued or switched at the investigators discretion
PROJECTED ACCRUAL There will be 525 patients accrued into this study from approximately 50 centers
OUTLINE This is a randomized double blind placebo controlled multicenter study Patients receive the matrix metalloprotease inhibitor AG3340 at one of two dosages or placebo orally twice a day beginning on day 1 Patients receive mitoxantrone by intravenous infusion on day 1 and prednisone orally twice daily beginning on day 1 Treatment course is repeated every 3 weeks in the absence of unacceptable toxicity Mitoxantrone andor prednisone may be discontinued or switched at the investigators discretion
PROJECTED ACCRUAL There will be 525 patients accrued into this study from approximately 50 centers
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000066320 | None | None | None |