NCT00288249

Brief Summary

The purpose of this study is to determine whether the study drug is effective and safe in the treatment of patients with metastatic breast cancer

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Dec 2005

Typical duration for phase_2

Geographic Reach
10 countries

21 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 6, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 7, 2006

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

December 2, 2014

Status Verified

November 1, 2014

Enrollment Period

2.2 years

First QC Date

February 6, 2006

Last Update Submit

November 27, 2014

Conditions

Breast NeoplasmsBreast Cancer, Metastatic

Keywords

Breast CancerBreast Neoplasms

Outcome Measures

Primary Outcomes (1)

  • Tumor response rate (complete or partial response according to RECIST)

    The proportion of subjects with either complete or partial response according to the modified RECIST criteria was calculated as best overall response after 6 courses of therapy (i.e., before Course 7).

    Every 6 weeks

Secondary Outcomes (2)

  • Duration of complete or partial tumor response

    Every 6 weeks

  • Time to tumor progression

    Every 6 weeks

Study Arms (4)

Arm 2

EXPERIMENTAL

Each subject was scheduled to receive one infusion of ZK 219477 every 3 weeks in one of the respective arms (16 mg/m2 in Arm 1, 12 mg/m2 in Arm 2, 22 mg/m2 \[30-minute infusion\] in Arm 3 and 22 mg/m2 \[3-hour infusion\] in Arm 4)

Drug: Sagopilone (BAY86-5302, ZK 219477)

Arm 3

EXPERIMENTAL

Each subject was scheduled to receive one infusion of ZK 219477 every 3 weeks in one of the respective arms (16 mg/m2 in Arm 1, 12 mg/m2 in Arm 2, 22 mg/m2 \[30-minute infusion\] in Arm 3 and 22 mg/m2 \[3-hour infusion\] in Arm 4)

Drug: Sagopilone (BAY86-5302, ZK 219477)

Arm 4

EXPERIMENTAL

Each subject was scheduled to receive one infusion of ZK 219477 every 3 weeks in one of the respective arms (16 mg/m2 in Arm 1, 12 mg/m2 in Arm 2, 22 mg/m2 \[30-minute infusion\] in Arm 3 and 22 mg/m2 \[3-hour infusion\] in Arm 4)

Drug: Sagopilone (BAY86-5302, ZK 219477)

Arm 1

EXPERIMENTAL

Each subject was scheduled to receive one infusion of ZK 219477 every 3 weeks in one of the respective arms (16 mg/m2 in Arm 1, 12 mg/m2 in Arm 2, 22 mg/m2 \[30-minute infusion\] in Arm 3 and 22 mg/m2 \[3-hour infusion\] in Arm 4)

Drug: Sagopilone (BAY86-5302, ZK 219477)

Interventions

Sagopilone (BAY86-5302, ZK 219477)DRUG

16 mg/m2, 3-hour i.v. infusion, 1 cycle every 3 weeks. Planned number of cycles : 2-6.

Arm 1

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Metastatic breast cancer
  • No previous treatment with taxanes, and vinca alkaloids
  • Use of highly effective birth control methods in females of child-bearing potential

You may not qualify if:

  • More than 2 previous chemotherapies
  • Previous participation in another trial within the last 4 weeks
  • Breast feeding
  • Active infections

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (21)

Unknown Facility

Vienna, Vienna, 1090, Austria

Location

Unknown Facility

Vienna, Vienna, 1100, Austria

Location

Unknown Facility

Brasschaat, 2930, Belgium

Location

Unknown Facility

Plovdiv, 4001, Bulgaria

Location

Unknown Facility

Sofia, 01784, Bulgaria

Location

Unknown Facility

Varna, 9000, Bulgaria

Location

Unknown Facility

Vandœuvre-lès-Nancy, France, 54500, France

Location

Unknown Facility

Angers, 49033, France

Location

Unknown Facility

Bordeaux, 33076, France

Location

Unknown Facility

Clermont-Ferrand, 63011, France

Location

Unknown Facility

Saint-Herblain, 44805, France

Location

Unknown Facility

Berlin, State of Berlin, 10117, Germany

Location

Unknown Facility

Forlì, FC, 47100, Italy

Location

Unknown Facility

Milan, MI, 20162, Italy

Location

Unknown Facility

Reggio Emilia, RE, 42100, Italy

Location

Unknown Facility

Olsztyn, 10-228, Poland

Location

Unknown Facility

Warsaw, 02-781, Poland

Location

Unknown Facility

Ljubljana, 1000, Slovenia

Location

Unknown Facility

Madrid, Madrid, 28040, Spain

Location

Unknown Facility

Málaga, Málaga, 29010, Spain

Location

Unknown Facility

Manchester, Greater Manchester, M20 4BX, United Kingdom

Location

MeSH Terms

Conditions

Breast NeoplasmsNeoplasm Metastasis

Interventions

sagopilone

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2006

First Posted

February 7, 2006

Study Start

December 1, 2005

Primary Completion

March 1, 2008

Study Completion

January 1, 2009

Last Updated

December 2, 2014

Record last verified: 2014-11

Locations

FR(5)BU(3)GB(1)PL(2)IT(3)ES(2)AU(2)BE(1)SL(1)DE(1)