NCT00329329

Study of Satraplatin With Capecitabine to Treat Advanced Solid Malignancies

Phase 1 Study of the Oral Platinum Agent Satraplatin in Combination With Capecitabine for the Treatment of Patients With Advanced Solid Malignancies

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Agennix · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the maximally tolerated dose (MTD) and Phase 2 recommended dose of satraplatin when administered in combination with capecitabine in patients with advanced solid malignancies.

Detailed description

This is a single center, open-label, non-randomized, Phase I dose finding study of the investigational, oral cytotoxic drug, satraplatin in combination with capecitabine 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

• Malignancies

Interventions

Type	Name	Description
DRUG	satraplatin and capecitabine	satraplatin and capecitabine dose escalated per the dosing scheme

Timeline

• Start date: 2006-05-01
• Primary completion: 2009-01-01
• Completion: 2009-02-01
• First posted: 2006-05-24
• Last updated: 2012-03-23

Locations

1 site across 1 country: United States