Evaluation of a New Agent for Treatment of Advanced Stage Breast Cancer - Full Text View

Sponsor:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00313248

Purpose

The purpose of this study is to evaluate whether treatment with a new drug called ZK-Epothilone (ZK-Epo) in patients with metastatic breast cancer helps to decrease or stop tumor growth.

Condition	Intervention	Phase
Breast Neoplasm	Drug: Sagopilone (ZK 219477)	Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Phase 2 Study to Investigate the Efficacy and Safety of ZK-Epothilone (ZK-Epo; ZK 219477) in Patients With Metastatic Breast Cancer

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:

Response to treatment with ZK-Epo after 6 cycles [ Time Frame: complete or partial response after 2 to 6 courses of therapy. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety and tolerability of ZK-Epo [ Time Frame: time to progression after start of study treatment and response duration from time between first date of confirmed PR or CR. ] [ Designated as safety issue: Yes ]

Enrollment:	65
Study Start Date:	March 2006
Study Completion Date:	November 2008
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Arm 1	Drug: Sagopilone (ZK 219477) All patients will receive ZK-Epo at a dose of 16mg/m2 as an intravenous infusion. Chemotherapy for recurrent breast cancer.
Experimental: Arm 2	Drug: Sagopilone (ZK 219477) Patients will receive 22mg/m2 as intravenous infusion.

Detailed Description:

This study has previously been registered by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.Bayer HealthCare Pharmaceuticals, Inc.is the sponsor of this study.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Metastatic breast cancer (meaning the cancer has spread beyond its original location)
At least one measurable lesion by CT or MRI
Progression of disease following previous therapy for breast cancer
Have received previous treatment with anthracyclines (e.g. doxorubicin[Adriamycin or Doxil] or epirubicin [Ellence]), taxanes (paclitaxel [Taxol or Abraxane] or docetaxel [taxotere]) for your breast cancer
Not be pregnant
Additional criteria to be determined at screening visit.

Exclusion Criteria:

More than 3 previous chemotherapy regimens
More than one treatment with non cytotoxic agents for breast cancer therapy (e.g. herceptin [trastuzumab] or Avastin [bevacizumab)
Prior treatment with epothilones (e.g. Ixabepilone)
Symptomatic brain metastases
Additional criteria to be determined at screening visit

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00313248

Show 25 Study Locations

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

Click here and search for drug information provided by the FDA. This link exits the ClinicalTrials.gov site

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product. This link exits the ClinicalTrials.gov site

No publications provided by Bayer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Morrow PK, Divers S, Provencher L, Luoh SW, Petrella TM, Giurescu M, Schmelter T, Wang Y, Hortobagyi GN, Vahdat LT. Phase II study evaluating the efficacy and safety of sagopilone (ZK-EPO) in patients with metastatic breast cancer that has progressed following chemotherapy. Breast Cancer Res Treat. 2010 Oct;123(3):837-42. Epub 2010 Aug 10.

Responsible Party:	Therapeutic Area Head, Bayer Healthcare Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:	NCT00313248 History of Changes
Other Study ID Numbers:	91466, 307975
Study First Received:	April 11, 2006
Last Updated:	November 8, 2011
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada

Keywords provided by Bayer:

Breast Cancer
Metastatic Breast Cancer

Additional relevant MeSH terms:

Breast Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on February 09, 2012