Clinical trial NCT00313248: Evaluation of a New Agent for Treatment of Advanced Stage Breast Cancer
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Neoplasm
Keywords: Breast Cancer
Metastatic Breast Cancer
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2006-04-12
Enrollment: 65
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Response to treatment with ZK-Epo after 6 cycles
timeFrame: complete or partial response after 2 to 6 courses of therapy.
Secondary outcomes:
measure: Safety and tolerability of ZK-Epo
timeFrame: time to progression after start of study treatment and response duration from time between first date of confirmed PR or CR.
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Anchorage
country: United States
state: Alaska
city: Tucson
country: United States
state: Arizona
city: Hot Springs
country: United States
state: Arkansas
city: Bakersfield
country: United States
state: California
city: Palm Springs
country: United States
state: California
city: Aurora
country: United States
state: Colorado
city: Washington
country: United States
state: District of Columbia
city: Daytona Beach
country: United States
state: Florida
city: Decatur
country: United States
state: Illinois
city: New Albany
country: United States
state: Indiana
city: Baltimore
country: United States
state: Maryland
city: Minneapolis
country: United States
state: Minnesota
city: Livingston
country: United States
state: New Jersey
city: New York
country: United States
state: New York
city: Syracuse
country: United States
state: New York
city: Portland
country: United States
state: Oregon
city: Pittsburgh
country: United States
state: Pennsylvania
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Tacoma
country: United States
state: Washington
city: Toronto
country: Canada
state: Ontario
city: Greenfield Park
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Quebec
country: Canada
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: 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. doi: 10.1007/s10549-010-1102-x. Epub 2010 Aug 10.