Prospective, Multicenter, Randomized, Independent-group, Open-label Phase II Study to Investigate the Efficacy, Safety and Tolerability of 4 Regimen With 3 Doses of ZK 219477 (16 and 12 mg/m2 Body Surface Area as 3-hour Infusion or 22 mg/m2 Body Surface Area as 30-minute or 3-hour Infusion) in Patients With Metastatic Breast Cancer

Bayer0 sites82 target enrollmentDecember 2005

Overview

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

Detailed Description

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Registry

clinicaltrials.gov

Start Date

December 2005

End Date

January 2009

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Bayer

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Arms & Interventions

Arm 2

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)

Intervention: Sagopilone (BAY86-5302, ZK 219477)

Arm 3

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)

Intervention: Sagopilone (BAY86-5302, ZK 219477)

Arm 4

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)

Intervention: Sagopilone (BAY86-5302, ZK 219477)

Arm 1

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)

Intervention: Sagopilone (BAY86-5302, ZK 219477)

Outcomes

Primary Outcomes

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

Time Frame: Every 6 weeks

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).