Satraplatin for Patients With Metastatic Breast Cancer (MBC)

Metastatic Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00265655
• Other study ID #: Protocol 05-021
• Status: Completed
• Phase: Phase 2
• First received: December 1, 2005
• Last updated: March 22, 2012
• Start date: November 2005
• Est. completion date: February 2008

Study information

• Verified date: March 2012
• Source: Agennix
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

1. Has cytologically or pathologically confirmed breast cancer that is metastatic

2. 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)

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

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

Locations

Country	Name	City	State
United States	US Oncology	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Agennix

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the objective response rate (ORR) of oral satraplatin in patients with metastatic breast cancer		1 year	Yes
Secondary	To determine duration of response		6 weeks	Yes
Secondary	To determine progression-free survival (PFS)		1 year	Yes
Secondary	To determine 1-year survival		1 year	Yes
Secondary	To evaluate the toxicities of satraplatin in MBC patients		6 weeks	Yes
Secondary	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	Yes