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

Breast Neoplasm Clinical Trial

Official title:

Phase 2 Study to Investigate the Efficacy and Safety of ZK-Epothilone (ZK-Epo; ZK 219477) in Patients With Metastatic Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00313248
• Other study ID #: 91466
• Secondary ID: 307975
• Status: Completed
• Phase: Phase 2
• First received: April 11, 2006
• Last updated: November 11, 2015
• Start date: April 2006
• Est. completion date: November 2008

Study information

• Verified date: November 2015
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: November 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasm
• Breast Neoplasms

Intervention

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.
• Sagopilone (ZK 219477)
Patients will receive 22mg/m2 as intravenous infusion.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response to treatment with ZK-Epo after 6 cycles		complete or partial response after 2 to 6 courses of therapy.	No
Secondary	Safety and tolerability of ZK-Epo		time to progression after start of study treatment and response duration from time between first date of confirmed PR or CR.	Yes

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