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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 01, 2014