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

NCT00125411 | Terminated Phase 1

• 1 other identifier: CO 04904
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Tumors

Keywords

satraplatin; docetaxel; cancer; Phase I; advanced solid tumors

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerated Dose and Safety

  3 weeks

Secondary Outcomes (1)

• Objective response rate

  3 weeks

Interventions

satraplatin and docetaxel DRUG

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 Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Agennix: lead

Study Sites (1)

University of Wisconsin Comprehensive Cancer Center

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

satraplatin; Docetaxel

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• George Wilding, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2005
• First Posted: August 1, 2005
• Study Start: March 1, 2007
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: March 26, 2012

Record last verified: 2012-03

Locations

US (1)