Clinical Trials/NCT00265655

NCT00265655CompletedPhase 2

Phase II of Oral Satraplatin in Patients With Metastatic Breast Cancer (MBC)

Agennix2 sites in 1 country40 target enrollmentStarted: November 1, 2005Last updated: March 28, 2012

Conditions

Drugs

Trial Snapshot

Phase: Phase 2
Status: Completed
Sponsor: Agennix
Enrollment: 40
Locations: 2
Primary Endpoint: To determine the objective response rate (ORR) of oral satraplatin in patients with metastatic breast cancer

Study Overview Study Design Eligibility Criteria Outcomes Investigators Sites Records & Identifiers Similar Trials

Study Overview

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.

Study Design

Study Type: Interventional
Allocation: Na
Intervention Model: Single Group
Primary Purpose: Treatment
Masking: None

Eligibility Criteria

Ages: 18 Years to — (Adult, Older Adult)
Sex: All
Accepts Healthy Volunteers: No

Inclusion 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

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

To determine the objective response rate (ORR) of oral satraplatin in patients with metastatic breast cancer

Time Frame: 1 year

Secondary Outcomes

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 progression(6 weeks)
To determine duration of response(6 weeks)
To determine progression-free survival (PFS)(1 year)
To evaluate the toxicities of satraplatin in MBC patients(6 weeks)
To determine 1-year survival(1 year)

Investigators

Sponsor

Agennix

Sponsor Class

Industry

Responsible Party

Sponsor

Study Sites (2)

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