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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
History of Changes
  Purpose

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


Condition Intervention Phase
Metastatic Breast Cancer
 Drug: Satraplatin
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II of Oral Satraplatin in Patients With Metastatic Breast Cancer (MBC)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Agennix:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 40
Study Start Date: November 2005
Study Completion Date: February 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Satraplatin
    Patients will receive 80mg/m2 Satraplatin on Days 1-5 of Cycles 1 and 2. A cycle consists of 21 days.
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00265655

Locations
United States, Texas
US Oncology
Dallas, Texas, United States, 75204
Sponsors and Collaborators
Agennix
Investigators
Principal Investigator: Joyce O'Shaughnessy, MD US Oncology
  More Information

No publications provided

Responsible Party: Agennix
ClinicalTrials.gov Identifier: NCT00265655     History of Changes
Other Study ID Numbers: Protocol 05-021
Study First Received: December 1, 2005
Last Updated: March 22, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
 Satraplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013