Safety and Efficacy Study of a New Chemotherapy Agent to Treat Metastatic Breast Cancer
This study has been completed.
Sponsor:
Bayer
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00288249
First received: February 6, 2006
Last updated: May 3, 2013
Last verified: May 2013
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Neoplasms Breast Cancer, Metastatic |
Drug: Sagopilone (BAY86-5302, ZK 219477) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Bayer:
Primary Outcome Measures:
- Tumor response rate (complete or partial response according to RECIST) [ Time Frame: Every 8 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Duration of complete or partial tumor response [ Time Frame: Every 8 weeks ] [ Designated as safety issue: No ]
- Time to tumor progression [ Time Frame: Every 8 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 80 |
| Study Start Date: | December 2005 |
| Study Completion Date: | January 2009 |
| Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Arm 2 |
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.
|
| Experimental: Arm 3 |
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.
|
| Experimental: Arm 4 |
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.
|
| Experimental: Arm 1 |
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.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00288249
Locations
| Austria | |
| Wien, Austria, 1090 | |
| Wien, Austria, 1100 | |
| Belgium | |
| Brasschaat, Belgium, 2930 | |
| Bulgaria | |
| Plovdiv, Bulgaria, 4001 | |
| Sofia, Bulgaria, 01784 | |
| Varna, Bulgaria, 9000 | |
| France | |
| Angers, France, 49033 | |
| Bordeaux, France, 33076 | |
| Clermont Ferrand, France, 63011 | |
| Saint Herblain Cedex, France, 44805 | |
| Vandoeuvre les Nancy, France, 54500 | |
| Germany | |
| Berlin, Germany, 10117 | |
| Italy | |
| Forlì, FC, Italy, 47100 | |
| Milano, MI, Italy, 20162 | |
| Reggio Emilia, RE, Italy, 42100 | |
| Poland | |
| Olsztyn, Poland, 10-228 | |
| Warszawa, Poland, 02-781 | |
| Slovenia | |
| Ljubljana, Slovenia, 1000 | |
| Spain | |
| Madrid, Spain, 28040 | |
| Málaga, Spain, 29010 | |
| United Kingdom | |
| Manchester, Greater Manchester, United Kingdom, M20 4BX | |
Sponsors and Collaborators
Bayer
Investigators
| Study Director: | Bayer Study Director | Bayer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Therapeutic Area Head, Bayer Healthcare AG |
| ClinicalTrials.gov Identifier: | NCT00288249 History of Changes |
| Other Study ID Numbers: | 91464, 2005-003216-30, 309544 |
| Study First Received: | February 6, 2006 |
| Last Updated: | May 3, 2013 |
| Health Authority: | Austria: Federal Ministry for Health and Women France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Federal Institute for Drugs and Medical Devices Italy: National Monitoring Centre for Clinical Trials - Ministry of Health Slovakia: State Institute for Drug Control Slovenia: Agency for Medicinal Products - Ministry of Health Spain: Spanish Agency of Medicines Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by Bayer:
|
Breast Cancer Breast Neoplasms |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms Neoplasms by Site Breast Diseases Skin Diseases Epothilones Tubulin Modulators |
Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013