Study of Satraplatin (JM-216) in Combination With Docetaxel
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|ClinicalTrials.gov Identifier: NCT00125411|
Recruitment Status : Terminated (Sponsor decided to discontinue study drug development.)
First Posted : August 1, 2005
Last Update Posted : March 26, 2012
This is a single center, open-label, non-randomized, Phase I dose finding study of the investigational, oral cytotoxic drug, satraplatin (JM-216), in combination with docetaxel in patients with advanced solid tumors for whom curative therapy is not available. Please refer to the Eligibility Criteria below for key inclusion and exclusion criteria.
PURPOSE: The purpose of this trial is to determine a tolerable dose and schedule for the combination of satraplatin and docetaxel when given to patients with advanced solid tumors.
WHAT IS SATRAPLATIN: Satraplatin is an oral, investigational anticancer drug that 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.
|Condition or disease||Intervention/treatment||Phase|
|Tumors||Drug: satraplatin and docetaxel||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||28 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Study of the Oral Platinum Agent Satraplatin (JM-216) in Combination With Docetaxel in Treatment of Advanced Malignancies|
|Study Start Date :||March 2007|
|Actual Primary Completion Date :||February 2009|
|Actual Study Completion Date :||February 2009|
Drug: satraplatin and docetaxel
Satraplatin - oral administration within 2 hours of docetaxel infusion. Subsequent dosing will be on days 2-5 at approximate 24 hour intervals.
Docetaxel will be administered as intravenous infusion over 1 hour followed by saline flush.
- Maximum Tolerated Dose and Safety [ Time Frame: 3 weeks ]
- Objective response rate [ Time Frame: 3 weeks ]
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): NCT00125411
|United States, Wisconsin|
|University of Wisconsin Comprehensive Cancer Center|
|Madison, Wisconsin, United States, 53792|
|Principal Investigator:||George Wilding, MD||University of Wisconsin, Madison|