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

Phase 1

Terminated

• Conditions: Tumors

• Registration Number: NCT00125411
• Lead Sponsor: Agennix

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2005-07-28
• Study First Submitted QC: 2005-07-28
• Study First Posted: 2005-08-01
• Study Start: 2007-03
• Primary Completion: 2009-02
• Study Completion: 2009-02
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-22
• Last Update Posted: 2012-03-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

• Histologically confirmed malignancy that is metastatic or unresectable and for which standard curative or palliative chemotherapy measures do not exist or are no longer effective
• Life expectancy of at least 3 months
• Measurable or evaluable disease
• ECOG performance status of <= 2
• Willingness and ability to give informed consent

Exclusion Criteria

• Women who are pregnant or breastfeeding
• Other chemotherapy treatment less than 4 weeks prior to enrollment
• Treatment with docetaxel or a platinum agent less than 3 months prior to enrollment
• Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Maximum Tolerated Dose and Safety	3 weeks

Secondary Outcome Measures

Name	Time	Method
Objective response rate	3 weeks

Trial Locations

Locations (1)

University of Wisconsin Comprehensive Cancer Center; 🇺🇸 Madison, Wisconsin, United States