Study of Satraplatin (JM-216) in Combination With Docetaxel | NCT00125411

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

NCT00125411

Sponsor

Agennix

Status

Terminated

Last Update Posted

Mar 26, 2012Estimated

Enrollment

28Actual

Phase

Phase 1

Conditions

Tumors

Interventions

satraplatin and docetaxel

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2012

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Sponsor decided to discontinue study drug development.

Expanded Access Info

Start Date

Mar 2007

Primary Completion Date

Feb 2009Actual

Completion Date

Feb 2009Actual

First Submitted Date

Jul 28, 2005

First Submission Date that Met QC Criteria

Jul 28, 2005

First Posted Date

Aug 1, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 22, 2012

Last Update Posted Date

Mar 26, 2012Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

28Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Measure	Description	Time Frame
Maximum Tolerated Dose and Safety		3 weeks

Measure	Description	Time Frame
Objective response rate		3 weeks

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
George Wilding, MD	University of Wisconsin, Madison	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Wisconsin Comprehensive Cancer Center		Madison	Wisconsin	53792	United States

Condition Browse Module

MeSH Terms

ID	Term
D009369	Neoplasms

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C081294	satraplatin
D000077143	Docetaxel

Ancestor Terms

ID	Term
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic

Browse Leaves

Not provided

Browse Branches

Not provided