- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00101400
BAY43-9006 - Phase II in Advanced Breast Cancer
November 19, 2013 updated by: Bayer
A Phase II Multicenter Uncontrolled Trial of BAY43-9006 in Subjects With Metastatic Breast Cancer.
The purpose of this study is to evaluate the anti-cancer activity and safety of BAY43-9006 (Sorafenib) in patients, who suffer from an advanced breast tumour, which has spread to other organs of body despite treatment that the patient has received so far.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
54
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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/µl
- 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 anti-epileptics)
- 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 drug
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Sorafenib (Nexavar, BAY43-9006)
Sorafenib 400 mg administered twice daily (b.i.d.)
|
Sorafenib 400 mg administered twice daily (b.i.d.)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Subjects With Response (Complete or Partial)
Time Frame: Until 30 days after termination of active therapy
|
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.
|
Until 30 days after termination of active therapy
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to Progression
Time Frame: Until progression occurs
|
Time from start of treatment until progression was first documented.
|
Until progression occurs
|
Time to Objective Response
Time Frame: Until objective response occurs
|
Defined only for subjects achieving objective tumor response from start of treatment to the date when confirmed PR or CR was first documented according to the Modified WHO Tumor Response Criteria.
|
Until objective response occurs
|
Overall Response Duration
Time Frame: Time from PR or CR to progression
|
Overall response duration was defined only for subjects achieving confirmed objective response (PR or CR).
It was measured from start of treatment to the date when progressive disease was first objectively documented.
|
Time from PR or CR to progression
|
Survival Time
Time Frame: Start of treatment to death
|
After the end of treatment visit (30 days after the last dose), the subjects were monitored every 3 months for survival (visits/phone calls).
|
Start of treatment to death
|
Number of Subjects With Stable Disease up to Cycle 4
Time Frame: Until 30 days after termination of active therapy
|
Number of subjects who had not responded to treatment but had stable disease up to cycle 4.
|
Until 30 days after termination of active therapy
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2004
Primary Completion (Actual)
January 1, 2006
Study Completion (Actual)
January 1, 2008
Study Registration Dates
First Submitted
January 10, 2005
First Submitted That Met QC Criteria
January 10, 2005
First Posted (Estimate)
January 11, 2005
Study Record Updates
Last Update Posted (Estimate)
December 13, 2013
Last Update Submitted That Met QC Criteria
November 19, 2013
Last Verified
November 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 100555
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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