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

Bayer

Status and phase: Completed; Phase 2

Conditions: Breast Neoplasms; Breast Cancer, Metastatic

Treatments: Drug: Sagopilone (BAY86-5302, ZK 219477)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00288249

309544 (Other Identifier)

91464

2005-003216-30 (EudraCT Number)

Details and patient eligibility

About

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

Full 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.

Enrollment: 82 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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82 participants in 4 patient groups

Arm 2

Experimental group

Description:

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)

Treatment:

Drug: Sagopilone (BAY86-5302, ZK 219477)

Drug: Sagopilone (BAY86-5302, ZK 219477)

Drug: Sagopilone (BAY86-5302, ZK 219477)

Drug: Sagopilone (BAY86-5302, ZK 219477)

Arm 3

Experimental group

Description:

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)

Treatment:

Drug: Sagopilone (BAY86-5302, ZK 219477)

Drug: Sagopilone (BAY86-5302, ZK 219477)

Drug: Sagopilone (BAY86-5302, ZK 219477)

Drug: Sagopilone (BAY86-5302, ZK 219477)

Arm 4

Experimental group

Description:

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)

Treatment:

Drug: Sagopilone (BAY86-5302, ZK 219477)

Drug: Sagopilone (BAY86-5302, ZK 219477)

Drug: Sagopilone (BAY86-5302, ZK 219477)

Drug: Sagopilone (BAY86-5302, ZK 219477)

Arm 1

Experimental group

Description:

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)

Treatment:

Drug: Sagopilone (BAY86-5302, ZK 219477)

Drug: Sagopilone (BAY86-5302, ZK 219477)

Drug: Sagopilone (BAY86-5302, ZK 219477)

Drug: Sagopilone (BAY86-5302, ZK 219477)