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Evaluation of a New Agent for Treatment of Advanced Stage Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00313248
Recruitment Status : Completed
First Posted : April 12, 2006
Last Update Posted : December 10, 2015
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief Summary:
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 or disease Intervention/treatment Phase
Breast Neoplasm Drug: Sagopilone (ZK 219477) Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : April 2006
Actual Primary Completion Date : October 2008
Actual Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
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.
Other Name: BAY86-5302

Experimental: Arm 2 Drug: Sagopilone (ZK 219477)
Patients will receive 22mg/m2 as intravenous infusion.
Other Name: BAY86-5302




Primary Outcome Measures :
  1. Response to treatment with ZK-Epo after 6 cycles [ Time Frame: complete or partial response after 2 to 6 courses of therapy. ]

Secondary Outcome Measures :
  1. 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. ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00313248


Locations
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United States, Alabama
Birmingham, Alabama, United States, 35233
United States, Alaska
Anchorage, Alaska, United States, 99508
United States, Arizona
Tucson, Arizona, United States, 85724
United States, Arkansas
Hot Springs, Arkansas, United States, 71913
United States, California
Bakersfield, California, United States, 93309
Palm Springs, California, United States, 92262
United States, Colorado
Aurora, Colorado, United States, 80010
United States, District of Columbia
Washington, District of Columbia, United States, 20007
United States, Florida
Daytona Beach, Florida, United States, 32114
United States, Illinois
Decatur, Illinois, United States, 62526
United States, Indiana
New Albany, Indiana, United States, 47150
United States, Maryland
Baltimore, Maryland, United States, 21204
United States, Minnesota
Minneapolis, Minnesota, United States, 55455
United States, New Jersey
Livingston, New Jersey, United States, 07039
United States, New York
New York, New York, United States, 10021
Syracuse, New York, United States, 13210
United States, Oregon
Portland, Oregon, United States, 97239
United States, Pennsylvania
Pittsburgh, Pennsylvania, United States, 15213-3180
United States, Texas
Houston, Texas, United States, 77030
San Antonio, Texas, United States, 78207
United States, Washington
Tacoma, Washington, United States, 98405
Canada, Ontario
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
Greenfield Park, Quebec, Canada, J4V 2H1
Montreal, Quebec, Canada, H3T 1E2
Canada
Quebec, Canada, G1S 4L8
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00313248    
Other Study ID Numbers: 91466
307975 ( Other Identifier: company internal )
First Posted: April 12, 2006    Key Record Dates
Last Update Posted: December 10, 2015
Last Verified: November 2015
Keywords provided by Bayer:
Breast Cancer
Metastatic Breast Cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Sagopilone
Epothilones
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action