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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00313248

Enrollment

Registered

2006-04-12

Start date

2006-04-30

Completion date

2008-11-30

Last updated

2015-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Neoplasm

Keywords

Breast Cancer, Metastatic Breast Cancer

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.

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.

Interventions

DRUGSagopilone (ZK 219477)

All patients will receive ZK-Epo at a dose of 16mg/m2 as an intravenous infusion. Chemotherapy for recurrent breast cancer.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Response to treatment with ZK-Epo after 6 cycles	complete or partial response after 2 to 6 courses of therapy.

Secondary

Measure	Time frame
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.

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026