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

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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)

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)

Trial contacts and locations

21

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Data sourced from clinicaltrials.gov

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