NCT00125411

Study of Satraplatin (JM-216) in Combination With Docetaxel

Phase I Study of the Oral Platinum Agent Satraplatin (JM-216) in Combination With Docetaxel in Treatment of Advanced Malignancies

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Agennix · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Tumors

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2007-03-01
• Primary completion: 2009-02-01
• Completion: 2009-02-01
• First posted: 2005-08-01
• Last updated: 2012-03-26

Locations

1 site across 1 country: United States