Satraplatin for Patients With Metastatic Breast Cancer (MBC)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Agennix
ClinicalTrials.gov Identifier:
NCT00265655
First received: December 1, 2005
Last updated: March 22, 2012
Last verified: March 2012

December 1, 2005
March 22, 2012
November 2005
January 2008   (final data collection date for primary outcome measure)
To determine the objective response rate (ORR) of oral satraplatin in patients with metastatic breast cancer [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
To determine the objective response rate (ORR) of oral satraplatin in MBC patients.
Complete list of historical versions of study NCT00265655 on ClinicalTrials.gov Archive Site
  • To determine duration of response [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
  • To determine progression-free survival (PFS) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • To determine 1-year survival [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • To evaluate the toxicities of satraplatin in MBC patients [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
  • 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 [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
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Satraplatin for Patients With Metastatic Breast Cancer (MBC)
Phase II of Oral Satraplatin in Patients With Metastatic Breast Cancer (MBC)

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

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.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Metastatic Breast Cancer
Drug: Satraplatin
Patients will receive 80mg/m2 Satraplatin on Days 1-5 of Cycles 1 and 2. A cycle consists of 21 days.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
February 2008
January 2008   (final data collection date for primary outcome measure)
  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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00265655
Protocol 05-021
Not Provided
Agennix
Agennix
Not Provided
Principal Investigator: Joyce O'Shaughnessy, MD US Oncology
Agennix
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP