Satraplatin for Patients With Metastatic Breast Cancer (MBC)

NCT ID: NCT00265655

Last Updated: 2012-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2008-02-29

Brief Summary

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

Detailed Description

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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.

Conditions

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Metastatic Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Satraplatin

Patients will receive 80mg/m2 Satraplatin on Days 1-5 of Cycles 1 and 2. A cycle consists of 21 days.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Has cytologically or pathologically confirmed breast cancer that is metastatic
2. Must have had prior HerceptinÃ’ 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)
3. Has had no more than 1 prior chemotherapy regimen for MBC
4. Has had no prior platinum-based therapy
5. Has an ECOG Performance Status (PS) 0-2
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Agennix

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joyce O'Shaughnessy, MD

Role: PRINCIPAL_INVESTIGATOR

US Oncology

Locations

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US Oncology

Dallas, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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Protocol 05-021

Identifier Type: -

Identifier Source: org_study_id

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