A Phase I Study of the Oral Platinum Agent Satraplatin in Combination With Weekly Docetaxel
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|ClinicalTrials.gov Identifier: NCT00313456|
Recruitment Status : Terminated (Sponsor decided to discontinue study drug development)
First Posted : April 12, 2006
Last Update Posted : May 10, 2012
|Condition or disease||Intervention/treatment||Phase|
|Tumors Prostate Cancer||Drug: Satraplatin||Phase 1|
Satraplatin is an oral platinum analog that is currently being evaluated in combination with prednisone in a phase III clinical trial in patients with HRPC who have progressed following one prior chemotherapy regimen.
Docetaxel is a taxane that is indicated for the treatment of patients with non-small cell lung, breast, and prostate cancers. Specifically, it was recently approved in combination with prednisone for the treatment of patients with hormone refractory prostate cancer (HRPC). Docetaxel administered every 3 weeks was associated with a survival advantage versus mitoxantrone. Docetaxel administered weekly showed an improvement in survival versus mitoxantrone that was not statistically significant. However, it was better tolerated than docetaxel administered every 3 weeks, with significantly less grade 3 and 4 toxicities, especially neutropenia. The combination of satraplatin and weekly docetaxel may be a feasible regimen for patients with chemotherapy-naïve HRPC and for patients with other malignancies for which these medications show activity.
The objective of this study is to determine the optimum doses for satraplatin and weekly docetaxel when the 2 drugs are given in combination.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study of the Oral Platinum Agent Satraplatin in Combination With Weekly Docetaxel|
|Study Start Date :||March 2006|
|Actual Primary Completion Date :||March 2009|
|Actual Study Completion Date :||March 2009|
- Drug: Satraplatin
Satraplatin is an oral platinum analogue that has shown promising activity in multiple tumor settings. Satraplatin (40 to 80 mg/m2/day) will be administered orally on days 1 to 5 of a 21 day cycle.
- To assess the maximum tolerated dose (MTD) of satraplatin administered every 4 weeks in combination with docetaxel administered weekly (3 of 4 weeks) [ Time Frame: 30 days ]
- To assess safety and tolerability (as per NCI-CTCAE version 3.0) [ Time Frame: 30 days ]
- To assess preliminary antitumor activity [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00313456
|United States, Tennessee|
|Sarah Cannon Research Institute|
|Nashville, Tennessee, United States|
|Study Director:||Michael Petrone, MD||GPC Biotech Inc.|