This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

This study has been terminated.
(Sponsor decided to discontinue study drug development.)
Information provided by (Responsible Party):
Agennix Identifier:
First received: July 28, 2005
Last updated: March 22, 2012
Last verified: March 2012

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 and docetaxel Phase 1

Study Type: Interventional
Study Design: 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:

Further study details as provided by Agennix:

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

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

Enrollment: 28
Study Start Date: March 2007
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
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.


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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

Responsible Party: Agennix Identifier: NCT00125411     History of Changes
Other Study ID Numbers: CO 04904
Study First Received: July 28, 2005
Last Updated: March 22, 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 processed this record on July 27, 2017