MedPath

Satraplatin for Patients With Metastatic Breast Cancer (MBC)

Phase 2
Completed
Conditions
Metastatic Breast Cancer
Registration Number
NCT00265655
Lead Sponsor
Agennix
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
40
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
To determine the objective response rate (ORR) of oral satraplatin in patients with metastatic breast cancer1 year
Secondary Outcome Measures
NameTimeMethod
In patients with nonmeasurable MBC, to assess the clinical utility of serum CA27.29 (or CA15.3) and circulating tumor cells as predictors of time to disease progression6 weeks
To determine 1-year survival1 year
To determine duration of response6 weeks
To determine progression-free survival (PFS)1 year
To evaluate the toxicities of satraplatin in MBC patients6 weeks

Trial Locations

Locations (1)

US Oncology

🇺🇸

Dallas, Texas, United States

© Copyright 2025. All Rights Reserved by MedPath