Satraplatin for Patients With Metastatic Breast Cancer (MBC) | NCT00265655

Studies
Satraplatin for Patients With Metastatic Breast Cancer (MBC)

NCT00265655

Sponsor

Agennix

Status

Completed

Last Update Posted

Mar 28, 2012Estimated

Enrollment

40Actual

Phase

Phase 2

Conditions

Metastatic Breast Cancer

Interventions

Satraplatin

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

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2005

Primary Completion Date

Jan 2008Actual

Completion Date

Feb 2008Actual

First Submitted Date

Dec 1, 2005

First Submission Date that Met QC Criteria

Dec 13, 2005

First Posted Date

Dec 15, 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

Mar 21, 2012

Certification/Extension First Submitted that Passed QC Review

Mar 22, 2012

Certification/Extension First Posted Date

Mar 28, 2012Estimated

Last Update Submitted Date

Mar 22, 2012

Last Update Posted Date

Mar 28, 2012Estimated

Description Module

Brief Summary

To determine the objective response rate (ORR) of oral satraplatin in patients with Metastatic Breast Cancer.

Detailed Description

This is a Phase II open label, nonrandomized study for patients with metastatic breast cancer.

WHAT IS SATRAPLATIN:

Satraplatin 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.

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Satraplatin	Drug	Patients will receive 80mg/m2 Satraplatin on Days 1-5 of Cycles 1 and 2. A cycle consists of 21 days.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To determine the objective response rate (ORR) of oral satraplatin in patients with metastatic breast cancer		1 year

Secondary Outcomes

Measure	Description	Time Frame
To determine duration of response		6 weeks
To determine progression-free survival (PFS)		1 year
To determine 1-year survival

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Has cytologically or pathologically confirmed breast cancer that is metastatic
Must have had prior HerceptinÒ therapy if patient has HER2+ (overexpressing) breast cancer. HER2 is considered overexpressed if it is 3+ by IHC or if the gene is amplified by Flourescence in situ hybridization (FISH)
Has had no more than 1 prior chemotherapy regimen for MBC
Has had no prior platinum-based therapy
Has an ECOG Performance Status (PS) 0-2

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
Joyce O'Shaughnessy, MD	US Oncology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
US Oncology		Dallas	Texas	75204	United States

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C081294	satraplatin

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided