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
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 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
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 31, 2014