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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

July 28, 2005

Last Updated Date

August 14, 2007

Start Date ^†

March 2007

Current Primary Outcome Measures ^†

Safety

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00125411 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Objective response rate

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

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

Official Title ^†

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

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

Study Phase

Phase I

Study Type ^†

Interventional

Study Design ^†

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Condition ^†

Tumors

Intervention ^†

Drug: satraplatin
Drug: docetaxel

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Enrollment ^†

Estimated Completion Date

February 2009

Primary Completion Date

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Contact: Katherine Oliver	608-263-6222	kah@medicine.wisc.edu
Contact: Dona Alberti, BSN, RN	608-263-6222	Dba@medicine.wisc.edu

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00125411

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

GPC Biotech

Collaborators ^††

Investigators ^†

Principal Investigator:

George Wilding, MD

University of Wisconsin, Madison

Information Provided By

GPC Biotech

Verification Date

August 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.