Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00069745
Status:
COMPLETED
Last Update Posted:
2012-08-07
First Post:
2003-09-30
Brief Title:
Satraplatin in Hormone Refractory Prostate Cancer Patients Previously Treated With One Cytotoxic Chemotherapy Regimen
Sponsor:
Agennix
Organization:
Agennix
Study Overview
Official Title:
A Multi-National Phase III Study of Satraplatin Plus Prednisone or Placebo Plus Prednisone in Patients With Hormone Refractory Prostate Cancer Previously Treated With One Cytotoxic Chemotherapy Regimen
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:
PURPOSE
The SPARC trial is designed to compare the combination of the investigational oral cytotoxic drug satraplatin and prednisone versus prednisone alone as second line chemotherapy in patients with hormone-refractory prostate cancer HRPC
TARGET PATIENT POPULATION
The SPARC trial is intended for patients who have hormone-refractory prostate cancer HRPC and whose disease has progressed after treatment with one chemotherapy regimen Please refer to the Eligibility Criteria page for the key inclusion and exclusion criteria
WHAT IS SATRAPLATIN
Satraplatin is a member of the platinum-based class of chemotherapy drugs Platinum-based drugs have been clinically proven to be one of the most effective classes of anticancer therapies Unlike the currently marketed platinum-based drugs satraplatin can be given orally Satraplatin is also the only platinum-based drug that has demonstrated efficacy against prostate cancer in a randomized trial
RATIONALE
There are currently no approved chemotherapy drugs for the second line treatment of hormone-refractory prostate cancer HRPC In a preliminary randomized trial conducted in Europe the combination of satraplatin and prednisone had superior activity compared to prednisone alone for the treatment of HRPC patients who had not previously been treated with chemotherapy
The SPARC trial is designed to compare the combination of the investigational oral cytotoxic drug satraplatin and prednisone versus prednisone alone as second line chemotherapy in patients with hormone-refractory prostate cancer HRPC
TARGET PATIENT POPULATION
The SPARC trial is intended for patients who have hormone-refractory prostate cancer HRPC and whose disease has progressed after treatment with one chemotherapy regimen Please refer to the Eligibility Criteria page for the key inclusion and exclusion criteria
WHAT IS SATRAPLATIN
Satraplatin is a member of the platinum-based class of chemotherapy drugs Platinum-based drugs have been clinically proven to be one of the most effective classes of anticancer therapies Unlike the currently marketed platinum-based drugs satraplatin can be given orally Satraplatin is also the only platinum-based drug that has demonstrated efficacy against prostate cancer in a randomized trial
RATIONALE
There are currently no approved chemotherapy drugs for the second line treatment of hormone-refractory prostate cancer HRPC In a preliminary randomized trial conducted in Europe the combination of satraplatin and prednisone had superior activity compared to prednisone alone for the treatment of HRPC patients who had not previously been treated with chemotherapy
Detailed Description:
None
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