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

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ClinicalTrials.gov Identifier: NCT00125411
Recruitment Status : Terminated (Sponsor decided to discontinue study drug development.)
First Posted : August 1, 2005
Last Update Posted : March 26, 2012
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Tumors Drug: satraplatin and docetaxel Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : March 2007
Primary Completion Date : February 2009
Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Docetaxel
U.S. FDA Resources

Intervention Details:
    Drug: 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.

Primary Outcome Measures :
  1. Maximum Tolerated Dose and Safety [ Time Frame: 3 weeks ]

Secondary Outcome Measures :
  1. Objective response rate [ Time Frame: 3 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00125411

United States, Wisconsin
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
Principal Investigator: George Wilding, MD University of Wisconsin, Madison

Responsible Party: Agennix
ClinicalTrials.gov Identifier: NCT00125411     History of Changes
Other Study ID Numbers: CO 04904
First Posted: August 1, 2005    Key Record Dates
Last Update Posted: March 26, 2012
Last Verified: March 2012

Keywords provided by Agennix:
Phase I
advanced solid tumors

Additional relevant MeSH terms:
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action