NCT00044525

CompletedPhase 2

Evaluation of BAY59-8862 in Taxane-Resistant Metastatic Brea...

Bayer Source

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Other study identifiers

Sponsor study identifier

10654

Study Type

interventional

Actual enrollment (reported)

82

Locations

7 countries

Sites

22

Timeline

Study Start

April 2002

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

February 2004

Actual (reported)

Study Completion

February 2004

Actual (reported)

Brief Summary

Breast cancer is the most common form of cancer among women in developing countries, accounting for approximately one-fifth of all female cancers in the United States. Although mortality rates are declining in some countries, it remains the leading cause of death in women aged 40-55 years. The median survival for women with metastatic breast cancer is 2-3 years but there is significant variability in this population. The primary goals of treatment in patients with metastatic breast cancer are improvement or maintenance of quality of life and prolongation of survival. The taxanes, paclitaxel and docetaxel, were incorporated into the treatment of metastatic breast cancer in the 1990's. The usefulness of the taxanes is limited by the development of tumor resistance to these agents. This phase II trial with BAY59-8862 will be conducted to determine the anti-tumor efficacy of BAY59-8862 in taxane-resistant metastatic breast cancer.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 82 participants
Study completion date: February 2004
Actual (reported)
Listed locations: 7 countries · 22 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
April 2002
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
August 30, 2002
Actual (reported)
First Posted
September 4, 2002
Actual (reported)
Primary Completion
February 2004
Actual (reported)
Study Completion
February 2004
Actual (reported)

Last Updated: December 23, 2014
Status Verified: December 2014
Last Update Submitted: December 18, 2014

Conditions

Breast Cancer, Metastatic Breast Neoplasms

Keywords

TaxaneBreast CancerMetastasis

Study Arms (1)

Arm 1

EXPERIMENTAL

Drug: BAY59-8862 (Cytotoxic Taxane)

Interventions

BAY59-8862 (Cytotoxic Taxane)Drug

1 h intravenous infusion every 3 weeks

Arm 1

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Female patients with a proven diagnosis of metastatic breast cancer
Measurable disease as defined by the presence of at least one measurable lesion

Sponsors & Collaborators

Bayer
Industrylead

Study Sites (22)

Stuttgart, Baden-Wurttemberg, 70376, Germany

Berlin, State of Berlin, 10117, Germany

Jena, Thuringia, 07740, Germany

Marousi, Attica, 15123, Greece

Heraklion, Crete, 711 10, Greece

Ashkelon, 78306, Israel

Haifa, 31096, Israel

MeSH Terms

Conditions

Breast NeoplasmsNeoplasm Metastasis

Interventions

IDN 5109

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

Bayer Study Director
Bayer
STUDY DIRECTOR

Enrollment

82 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

August 30, 2002

First Posted

September 4, 2002

Study Start

April 2002

Date type not reported

This date has not been verified as actual or estimated.

NCT00062686

GW572016 For Treatment Of Refractory Metastatic Breast Cancer

Phase 2Completed

NCT00188669

The Use of Pentoxifylline and Vitamin E in the Treatment of Chronic Breast Pain

Phase 2Terminated

NCT00313248

Evaluation of a New Agent for Treatment of Advanced Stage Breast Cancer

Phase 2Completed

NCT00040014

Open Label, Multicenter, Randomized, Controlled Study of IM or Oral Exemestane (Aromasin) in Postmenopausal Women

Phase 2Terminated

NCT00051051

A Phase II Study of CI-1033 in Treating Patients With Metastatic (Stage IV) Breast Cancer

Phase 2Completed

NCT00052169

Therapy With Docetaxel and ZD1839 for Patients Who Have Advanced Breast Cancer

Phase 2Completed

Patients must have received at least 3 weeks of continuous therapy with Taxane

patient must subsequently develop progressive disease either during treatment or within 6 months after treatment

Patients who failed on hormone therapy

Life expectancy of at least 12 weeks.

Adequate bone marrow, liver and kidney function

Patients with active brain metastases may be included

You may not qualify if:

Excluded medical conditions like: pre-existing neuropathy, active heart diseases or ischemia; surgery within 4 weeks of study entry; serious infections; HIV infection; chronic hepatitis B or C; patients with brain metastases must be without a seizure; hypersensitivity to taxanes; organ transplants; some previous cancers
Excluded therapies and medications, previous and concomitant such as: anticancer chemotherapy or immunotherapy during the study or within 4 weeks prior to study entry; more than two prior anticancer chemotherapy regimens; radiotherapy during study or within 4 weeks prior to study entry; bone marrow transplant
Others: pregnant or breast-feeding patients; women enrolled in this trial must use adequate barrier birth control measures during the course of the trial; substance abuse, medical, psychological or social conditions that may interfere with the patient's participation.

Contact the study team to confirm eligibility.

Tel Aviv, 64239, Israel

Tel Litwinsky, 52621, Israel

Treviglio, Bergamo, 24047, Italy

Rozzano, Milano, 20089, Italy

Biella, 13900, Italy

Cuneo, 12100, Italy

Forlì, 47100, Italy

Parma, 43100, Italy

Udine, 33100, Italy

Olsztyn, 10-228, Poland

Warsaw, 00-909, Poland

Warsaw, 02-781, Poland

Aarau, Canton of Aargau, 5001, Switzerland

London, Greater London, NW3 2QG, United Kingdom

London, Greater London, SW3 6JJ, United Kingdom

Primary Completion

February 2004

Actual (reported)

Study Completion

February 2004

Actual (reported)

Last Updated

December 23, 2014

Record last verified: 2014-12

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00044525
Data provider: ClinicalTrials.gov
Source updated: 2014-12-23
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:36:40 UTC

Locations

CH(1)DE(3)GB(2)GR(2)IL(4)IT(7)PL(3)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Study Arms (1)

Arm 1

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (22)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations