BAY43-9006 - Phase II in Advanced Breast Cancer

NCT00101400 | Completed Phase 2 Results

• 1 other identifier: 100555
• Study Type: interventional
• Target: 54
• Locations: 2 countries
• Sites: 7

Brief Summary

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.

Conditions

Breast Neoplasms; Breast Cancer

Keywords

Cancer

Outcome Measures

Primary Outcomes (1)

• Number of Subjects With Response (Complete or Partial)

  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 Outcomes (5)

• Time to Progression

  Until progression occurs

• Time to Objective Response

  Until objective response occurs

• Overall Response Duration

  Time from PR or CR to progression

• Survival Time

  Start of treatment to death

• Number of Subjects With Stable Disease up to Cycle 4

  Until 30 days after termination of active therapy

Study Arms (1)

Sorafenib (Nexavar, BAY43-9006)

EXPERIMENTAL

Sorafenib 400 mg administered twice daily (b.i.d.)

Drug: Sorafenib (Nexavar, BAY43-9006)

Interventions

Sorafenib (Nexavar, BAY43-9006) DRUG

Sorafenib 400 mg administered twice daily (b.i.d.)

Sorafenib (Nexavar, BAY43-9006)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (7)

Unknown Facility

Stuttgart, Baden-Wurttemberg, 70199, Germany

Location

Unknown Facility

München, Bavaria, 80637, Germany

Location

Unknown Facility

Frankfurt am Main, Hesse, 60590, Germany

Location

Unknown Facility

Bologna, 40138, Italy

Location

Unknown Facility

Milan, 20133, Italy

Location

Unknown Facility

Milan, 20162, Italy

Location

Unknown Facility

Parma, 43100, Italy

Location

Related Publications (1)

• Bianchi G, Loibl S, Zamagni C, Salvagni S, Raab G, Siena S, Laferriere N, Pena C, Lathia C, Bergamini L, Gianni L. Phase II multicenter, uncontrolled trial of sorafenib in patients with metastatic breast cancer. Anticancer Drugs. 2009 Aug;20(7):616-24.

  PMID: 19739318 RESULT

MeSH Terms

Conditions

Breast Neoplasms; Neoplasms

Interventions

Sorafenib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Limitations and Caveats

Subjects had advanced disease and were heavily pretreated. Not all adverse events mentioned were assessed as drug-related. NCI-CTCAE was translated to Medical Dictionary for Regulatory Activities (MedDRA) for System Organ Classes (SOCs) only.

Results Point of Contact

• Title: Therapeutic Area Head
• Organization: BAYER

clinical-trials-contact@bayerhealthcare.com

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

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: January 10, 2005
• First Posted: January 11, 2005
• Study Start: February 1, 2004
• Primary Completion: January 1, 2006
• Study Completion: January 1, 2008
• Last Updated: December 13, 2013
• Results First Posted: June 23, 2009

Record last verified: 2013-11

Locations

IT (4); DE (3)