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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified August 2007 by GPC Biotech. Recruitment status was Recruiting

First Received on July 28, 2005. Last Updated on August 14, 2007 History of Changes

Sponsor:	GPC Biotech
Information provided by:	GPC Biotech
ClinicalTrials.gov Identifier:	NCT00125411

Purpose

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.

Condition	Intervention	Phase
Tumors	Drug: satraplatin Drug: docetaxel	Phase I

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Phase I Study of the Oral Platinum Agent Satraplatin (JM-216) in Combination With Docetaxel in Treatment of Advanced Malignancies

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Docetaxel JM 216

U.S. FDA Resources

Further study details as provided by GPC Biotech:

Primary Outcome Measures:

Safety

Secondary Outcome Measures:

Objective response rate

Study Start Date:	March 2007
Estimated Study Completion Date:	February 2009

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00125411

Contacts

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

Locations

United States, Wisconsin
University of Wisconsin Comprehensive Cancer Center	Recruiting
Madison, Wisconsin, United States, 53792
Contact: George Wilding, MD 608-263-8600
Principal Investigator: George Wilding, MD

Sponsors and Collaborators

GPC Biotech

Investigators

Principal Investigator:

George Wilding, MD

University of Wisconsin, Madison

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00125411 History of Changes
Other Study ID Numbers:	CO 04904
Study First Received:	July 28, 2005
Last Updated:	August 14, 2007
Health Authority:	United States: Food and Drug Administration

Keywords provided by GPC Biotech:

satraplatin
docetaxel
cancer
Phase I
advanced solid tumors

Additional relevant MeSH terms:

Docetaxel
Satraplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012