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A Phase II Multicenter Uncontrolled Trial of BAY43-9006 in Subjects With Metastatic Breast Cancer.

Phase 2
18 Years
Not Enrolling
Breast Neoplasms, Breast Cancer

Thank you

Trial Information

A Phase II Multicenter Uncontrolled Trial of BAY43-9006 in Subjects With Metastatic Breast Cancer.

Inclusion Criteria:

- Age > 18 years

- Women with prior histologically documented diagnosis of breast cancer

- Subjects with metastatic disease who have already received and failed at least one
chemotherapy regimen for metastatic disease and, if ER/PgR +ve, have failed on at
least adjuvant hormonal therapy

- Subjects for whom trastuzumab treatment is not indicated, no longer effective or
refused by the subjects

- Four weeks since the last cytotoxic chemotherapy or clear evidence of progression on
hormonal therapy

- Subjects who have at least one measurable lesion by CT (Computed Tomography) scan or
MRI (Magnetic Resonance Imaging) according to modified WHO Tumour Response Criteria

- Subjects who have an Eastern Co-operative Oncology Group (ECOG) performance status of
0, 1 or 2

- Adequate bone marrow, liver and renal function as assessed by the following
laboratory evaluations:

- Hemoglobin > 9.0 g/dl

- Absolute neutrophil count (ANC) > 1,500/mm3

- Platelet count = 100,000/┬Ál

- Total bilirubin =1.5 x the upper limit of normal.

- Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) = 2.5 x
upper limit of normal (=5 x upper limit of normal for subjects with liver
involvement of their cancer)

- Amylase and lipase = 1.5 x the upper limit of normal

- Serum creatinine = 3.0 x the upper limit of normal

- Prothrombin Time (PT) or International Normalized Ratio (INR) and Partial
Thromboplastin Time (PTT) < 1.5 x upper limit of normal (subjects who receive
anti-coagulation treatment with an agent such as warfarin or heparin will be
allowed to participate provided that no evidence of underlying abnormality in
these parameters exists)

- Subjects who give written informed consent prior to any study specific screening
procedures with the understanding that the subject has the right to withdraw from the
study at any time, without prejudice

- Life expectancy of at least 12 weeks

- Signed informed consent must be obtained prior to any study specific procedures

Exclusion Criteria:

- Previous malignancy (except for cervical carcinoma in situ, adequately treated basal
cell carcinoma, or superficial bladder tumours [Ta, Tis and T1] or other malignancies
curatively treated > 2 years prior to entry)

- Congestive heart failure > New York Heart Association (NYHA) Class II

- Cardiac arrhythmia requiring anti-arrhythmic (excluding beta blockers or digoxin)

- Active coronary artery disease or ischaemia

- Active clinically serious bacterial or fungal infections (> grade 2 National Cancer
Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 3)

- Known History of Human Immunodeficiency Virus (HIV) infection or chronic hepatitis B
or C

- Metastatic brain or meningeal tumors unless the subject is > 6 months from definitive
therapy, has a negative imaging study within 4 weeks of study entry and is clinically
stable with respect to the tumor at the time of study entry. Also the patient must
not be undergoing acute steroid therapy or taper (chronic steroid therapy is
acceptable provided that the dose is stable for 1 month prior to and following
screening radiographic study)

- Subjects with seizure disorders requiring medication (such as steroid or

- History of organ allograft

- Substance abuse, medical, psychological or social conditions that may interfere with
the subject's participation in the study or evaluation of the study results

- Known or suspected allergy to the investigational agent

- Any condition that is unstable or which could jeopardize the safety of the subject
and his/her compliance in the study. Pregnant or breast-feeding subjects. Women of
childbearing potential must have a negative pregnancy test performed within seven
days prior to the start of study drug. Women enrolled in this trial must use adequate
barrier birth control measures during the course of the trial.

Excluded therapies include:

- Anti-cancer chemotherapy, hormonal therapy or immunotherapy during the study or
within 4 weeks of study entry. Mytomicin or nitroureas should not be given within 6
weeks of study entry

- Significant surgery within 4 weeks prior to the start of study drug

- Any bone marrow transplant or stem cell rescue within 4 months of the start of study

- Radiotherapy during the study or within 3 weeks of the start of drug

- Use of biologic response modifiers, such as Granulocyte-Colony Stimulating Factor
(G-CSF), within 3 weeks of study entry

- Investigational drug therapy outside of this trial during or within 30 days prior to
start of the study drug

- Concomitant treatment with ketoconazole, itraconazole, ritonavir, or use of
grapefruit juice

- Prior use of Raf-Kinase Inhibitors (RKI), Methyl Ethyl Ketone (MEK) or farnesyl
transferase inhibitors

- Concomitant treatment or use of St. John's Wort

- Prior use of bevacizumab and all other drugs that target Vascular Endothelial Growth
Factor (VEGF)/VEGF receptors

Type of Study:


Study Design:

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

Outcome Measure:

Number of Subjects With Response (Complete or Partial)

Outcome Description:

Number of subjects with metastatic breast cancer treated with single agent BAY43-9006 who had best overall response assessed as complete response (CR) or partial response (PR) as per Modified World Health Organization (WHO) Tumor Response Criteria.

Outcome Time Frame:

Until 30 days after termination of active therapy

Safety Issue:


Principal Investigator

Bayer Study Director

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

February 2004

Completion Date:

January 2008

Related Keywords:

  • Breast Neoplasms
  • Breast Cancer
  • Cancer
  • Breast Neoplasms
  • Neoplasms