A PHASE 2 STUDY OF THE EFFICACY AND SAFETY OF SU-014813 IN PATIENTS WITH METASTATIC BREAST CANCER

Phase 1

Conditions: Histologically or cytological proven diagonis of metastatic breast adenocarcinoma that is not amenable to surgery, radiation, or combined modality therapy with curative intent.
MedDRA version: 8.0Level: LLTClassification code 10055113

Registration Number: EUCTR2005-004941-33-GB

Lead Sponsor: PFIZER Inc

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 70

Inclusion Criteria

1. Histologically or cytologically proven diagnosis of metastatic breast
adenocarcinoma that is not amenable to surgery, radiation, or combined modality
therapy with curative intent.
2. Must have received prior treatment with an anthracycline and a taxane either
concurrently or sequentially in the adjuvant and/or advanced disease treatment
settings. Patients whose tumors are Her-2-positive must have received prior
trastuzumab therapy.Patients may have received as many as 2 other
chemotherapy regimens in the advanced disease setting.
Prior hormonal therapy or immunotherapy in the adjuvant and/or
advanced/metastatic disease settings is permitted.
Prior treatment with surgery, radiotherapy, chemoembolization
therapy, or cryotherapy is allowed if these therapies did not affect the areas of
measurable disease.
3. If patient has only received treatment in the adjuvant setting, patient must have
experienced relapse or progression of disease during treatment or within 12
months of the last dose of adjuvant therapy.
4. Completion of all prior chemotherapy, and radiotherapy more than/or 3 weeks
prior to study entry, and resolution of all acute toxic effects of any prior cytokine
therapy, radiotherapy, or surgical procedure to National Cancer Institute (NCI)
Common Terminology Criteria for Adverse Events (version 3.0) grade less
than/equal to grade 1.
5. Patients on bisphosphonate therapy for metastatic bone disease must have
initiated therapy >3 months prior to study entry.
6. Evidence of unidimensionally measurable disease according to RECIST criteria.
7. Female
8. Eighteen years of age or older.
9. ECOG (Eastern Cooperative Oncology Group) performance status 0 or 1.
10. Adequate organ function as defined by the following criteria:
• Serum aspartate aminotransferase (AST; serum glutamate-oxalate
transferase [SGOT]) and serum alanine aminotransferase (ALT; serum
glutamate-pyruvate transferase [SGPT]) less than/equal to 2.5 x laboratory
upper limit of normal (ULN). If liver function abnormalities are due to
underlying malignancy, then AST and ALT may be less than/equal to
5 x CL-ULN
•Total serum bilirubin less than /equal to 1.5 x ULN
•Prothrombin time (PT) and partial thromboplastin time (PTT) less
than /equal to 1.5 x ULN
•Serum albumin =3.0 g/dL
•Absolute neutrophil count (ANC) =1500 mm3
•Platelets = 100,000 mm3
•Hemoglobin = 9.0 g/dL
•Serum creatinine less than/equal to 1.5 x ULN

11. Willingness and ability to comply with scheduled visits, treatment plans,
laboratory tests, and other study procedures.
12. Signed and dated informed consent document indicating that the patient has
been informed of all pertinent aspects of he trial prior to enrollment.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Prior treatment with =3 regimens of chemotherapy in the metastatic disease
setting beyond those containing anthracyclines and taxanes.
2. Prior treatment with any tyrosine kinase inhibitors, VEGF inhibitors, or other
angiogenic inhibitors.
3. Previous high-dose chemotherapy requiring hematopoietic stem cell rescue.
4. Prior radiation therapy to >25% of the bone marrow.
5. Current treatment on another clinical trial.
6. Uncontrolled brain metastases, spinal cord compression, or carcinomatous
meningitis, or new evidence of brain or leptomeningeal disease. Patients should
have completed surgery or radiation therapy for existing brain metastases,
should not have documented increase in size over the previous 3 months and
should be asymptomatic.
7. Diagnosis of any second non-breast malignancy within the last 5 years, except
for adequately treated basal cell carcinoma or for in situ carcinoma of the cervix
uteri.
8. Any of the following within the 12 months prior to study drug administration:
severe/unstable angina, symptomatic congestive heart failure, or
cerebrovascular accident including ischemic attack or pulmonary embolism.
9. Known human immunodeficiency virus (HIV) or acquired immunodeficiency
syndrome (AIDS)-related illness.
10. Presence of malabsorption due to prior surgery, gastrointestinal disease or for
an unknown reason, or inability to take oral medication. Patients may have had
major GI surgery but must not have residual symptomatic manifestation of
malabsorption.
11. Pregnancy or breast-feeding. Patients must be surgically sterile or be
postmenopausal, or must agree to use effective contraception during the period
of therapy. All patients with reproductive potential must have a negative
pregnancy test prior to study treatment . The definition of effective
contraception will be based on the judgment of the principal investigator or a
designated associate.
12. Other severe acute or chronic medical or psychiatric condition, or laboratory
abnormality that may increase the risk associated with study participation or
study drug administration, or may interfere with the interpretation of study
results, and in the judgment of the investigator would make the patient
inappropriate for entry into this study.