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

NCT ID: NCT00125411

Last Updated: 2012-03-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-03-31
• Study Completion Date: 2009-02-28

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.

Conditions

Tumors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Agennix

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

George Wilding, MD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

University of Wisconsin Comprehensive Cancer Center

Madison, Wisconsin, United States

Countries

United States

Other Identifiers

CO 04904

Identifier Type: -

Identifier Source: org_study_id