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An Uncontrolled Phase II Study Evaluating the Efficacy and Safety of Intravenous BAY59-8862 in Patients With Taxane-Resistant Metastatic Breast Cancer


Phase 2
18 Years
N/A
Not Enrolling
Female
Breast Neoplasms, Breast Cancer, Metastatic

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Trial Information

An Uncontrolled Phase II Study Evaluating the Efficacy and Safety of Intravenous BAY59-8862 in Patients With Taxane-Resistant Metastatic Breast Cancer


Inclusion Criteria:



- Female patients with a proven diagnosis of metastatic breast cancer

- Measurable disease as defined by the presence of at least one measurable lesion

- 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

Exclusion Criteria:

- 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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Bayer Study Director

Investigator Role:

Study Director

Investigator Affiliation:

Bayer

Authority:

United States: Food and Drug Administration

Study ID:

10654

NCT ID:

NCT00044525

Start Date:

April 2002

Completion Date:

February 2004

Related Keywords:

  • Breast Neoplasms
  • Breast Cancer, Metastatic
  • Taxane
  • Breast Cancer
  • Metastasis
  • Breast Neoplasms
  • Neoplasms

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