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

Tumors Clinical Trial

Official title:

Phase I Study of the Oral Platinum Agent Satraplatin (JM-216) in Combination With Docetaxel in Treatment of Advanced Malignancies

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00125411
• Other study ID #: CO 04904
• Status: Terminated
• Phase: Phase 1
• First received: July 28, 2005
• Last updated: March 22, 2012
• Start date: March 2007
• Est. completion date: February 2009

Study information

• Verified date: March 2012
• Source: Agennix
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 28
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tumors

Intervention

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.

Locations

Country	Name	City	State
United States	University of Wisconsin Comprehensive Cancer Center	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Agennix

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Tolerated Dose and Safety		3 weeks	Yes
Secondary	Objective response rate		3 weeks	Yes