Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
GPC Biotech |
---|---|
Information provided by: | GPC Biotech |
ClinicalTrials.gov Identifier: | NCT00450970 |
The SPERA trial is designed to 1. provide satraplatin to physicians with patients who have hormone refractory prostate cancer (HRPC) which has progressed following unlimited cytotoxic chemotherapy regimens for metastatic disease and 2. to evaluate the safety of oral satraplatin in this patient population.
Condition | Intervention | Phase |
---|---|---|
Prostate Cancer |
Drug: Oral Satraplatin |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | Expanded Access Study of Satraplatin Plus Prednisone in Patients With Hormone Refractory Prostate Cancer (HRPC) Previously Treated With Unlimited Cytotoxic Chemotherapy Regimen (SPERA) |
Estimated Enrollment: | 1000 |
Study Start Date: | February 2007 |
Estimated Study Completion Date: | December 2007 |
*****UPDATE***** On October 30th, 2007 GPC Biotech announced topline overall survival results for the Phase III trial in hormone refractory prostate cancer-Satraplatin and Prednisone Against Refractory Cancer (SPARC) trial.
The trial evaluated satraplatin plus prednisone versus placebo plus prednisone as a second-line treatment in 950 patients with hormone-refractory prostate cancer (HRPC). The companies reported that the trial did not achieve the endpoint of overall survival (p=0.80, stratified log rank analysis). The median was 61.3 weeks for the satraplatin arm compared to 61.4 weeks for the control group and the hazard ratio was 0.97 (95% CI: 0.83, 1.13). The companies are currently conducting pre-specified subset analyses.
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Philippe Pultar, MD | GPC Biotech Inc. |
Study ID Numbers: | SAT3-06-04 |
Study First Received: | March 20, 2007 |
Last Updated: | January 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00450970 |
Health Authority: | United States: Food and Drug Administration |
Hormone Refractory Prostate Cancer (HRPC) Hormone Refractory Prostate Cancer Unlimited Prior Cytotoxic Chemotherapy Regimens |
Prednisone Satraplatin Prostatic Diseases Genital Neoplasms, Male |
Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms |
Neoplasms Neoplasms by Site Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |