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

Breast Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00288249
• Other study ID #: 91464
• Secondary ID: 2005-003216-3030
• Status: Completed
• Phase: Phase 2
• First received: February 6, 2006
• Last updated: November 27, 2014
• Start date: December 2005
• Est. completion date: January 2009

Study information

• Verified date: November 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Ministry for Health and WomenFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesItaly: National Monitoring Centre for Clinical Trials - Ministry of HealthSlovakia: State Institute for Drug ControlSlovenia: Agency for Medicinal Products - Ministry of HealthSpain: Spanish Agency of MedicinesBelgium: The Federal Public Service (FPS) Health, Food Chain Safety and EnvironmentPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: January 2009
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer, Metastatic
• Breast Neoplasms

Intervention

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.
• Sagopilone (BAY86-5302, ZK 219477)
12 mg/m2, 3-hour i.v. infusion, 1 cycle every 3 weeks. Planned number of cycles : 2-6.
• Sagopilone (BAY86-5302, ZK 219477)
22 mg/m2, 30-minute i.v. infusion, 1 cycle every 3 weeks. Planned number of cycles : 2-6.
• Sagopilone (BAY86-5302, ZK 219477)
22 mg/m2, 3-hour i.v. infusion, 1 cycle every 3 weeks. Planned number of cycles : 2-6.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Duration of complete or partial tumor response	Defined as the time between the first date that confirmed complete or partial response was established as "overall response" and the first date that recurrence or overall response of progressive disease was documented	Every 6 weeks	No
Secondary	Time to tumor progression	Defined as the time from the start of study treatment to the first objective evidence of tumor progression, symptomatic deterioration, or death from cancer	Every 6 weeks	No

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