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

Sponsored by:	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

MedlinePlus related topics: Cancer

Drug Information available for: Docetaxel JM 216

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase I Study of the Oral Platinum Agent Satraplatin (JM-216) in Combination With Docetaxel in Treatment of Advanced Malignancies

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

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

Keywords provided by GPC Biotech:

satraplatin
docetaxel
cancer
Phase I
advanced solid tumors

Study placed in the following topic categories:

Docetaxel
Satraplatin

Additional relevant MeSH terms:

Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009