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

This study has been terminated.
(Sponsor decided to discontinue study drug development.)
Sponsor:
Information provided by (Responsible Party):
Agennix
ClinicalTrials.gov Identifier:
NCT00125411
First received: July 28, 2005
Last updated: March 22, 2012
Last verified: March 2012
  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 and docetaxel
Phase 1

Study Type: Interventional
Study Design: 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:


Further study details as provided by Agennix:

Primary Outcome Measures:
  • Maximum Tolerated Dose and Safety [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Objective response rate [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]

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.

  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

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

No publications provided

Responsible Party: Agennix
ClinicalTrials.gov Identifier: NCT00125411     History of Changes
Other Study ID Numbers: CO 04904
Study First Received: July 28, 2005
Last Updated: March 22, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Agennix:
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 April 20, 2014