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Safety and Efficacy Study of a New Chemotherapy Agent to Treat Metastatic Breast Cancer

NCT00288249 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2014-12-02

No results posted yet for this study

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

Conditions

  • Breast Neoplasms
  • Breast Cancer, Metastatic

Interventions

DRUG

Sagopilone (BAY86-5302, ZK 219477)

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

DRUG

Sagopilone (BAY86-5302, ZK 219477)

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

DRUG

Sagopilone (BAY86-5302, ZK 219477)

22 mg/m2, 30-minute i.v. infusion, 1 cycle every 3 weeks. Planned number of cycles : 2-6.

DRUG

Sagopilone (BAY86-5302, ZK 219477)

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

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-12-31
Primary Completion
2008-03-31
Completion
2009-01-31

Countries

  • Austria
  • Belgium
  • Bulgaria
  • France
  • Germany
  • Italy
  • Poland
  • Slovenia
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00288249 on ClinicalTrials.gov