Clinical trial NCT00270413 (phase 2, status: completed)
Conditions: metastatic breast cancer
ICD codes: C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60
Drugs: su11248
SMILES: CCN(CC)CCNC(=O)C1=C(C)NC(\C=C2/C(=O)NC3=C2C=C(F)C=C3)=C1C
Eligibility criteria:

        Inclusion Criteria:

          -  Patients with metastatic breast cancer, histologically proven

          -  Patients received taxane based chemotherapy resulting in PR or CR, and thus had
             measurable disease at the start of taxane therapy (RECIST)

          -  No more than 2 lines (taxanes included) in metastatic setting

          -  Patients have received at least 10 weeks of taxane therapy (4 cycles of 3-weekly
             therapy or 8 weekly administrations) and no more than 20 weeks of treatment (6 cycles
             of 3-weekly therapy or 16 weekly administrations). 6 cycles of 3-weekly taxanes or
             12-16 cycles of weekly taxanes are recommended.

          -  Last taxane administration between 3 and 4 weeks for 3 weekly taxane or between 2 and
             3 weeks for weekly taxanes

          -  Performance status 0 to 1 on the ECOG scale (Appendix A)

          -  Age > 18 years

          -  Adequate organ function as defined by:

          -  Serum aspartate aminotransferase (AST; serum glutamate-oxalate transferase [SGOT]) and
             serum alanine aminotransferase (ALT; serum glutamate-pyruvate transferase [SGPT]) ≤2.5
             x central laboratory upper limit of normal (CL-ULN). If liver function abnormalities
             are due to underlying malignancy, then AST and ALT may be ≤5 x CL-ULN

          -  Prothrombin time (PT) > 50%

          -  Serum albumin ≥3.0 g/dL

          -  Absolute neutrophil count (ANC) ≥1500/µL

          -  Platelets ≥100,000/µL

          -  Hemoglobin ≥9.0 g/dL

          -  Serum creatinine ≤1.5 x CL-ULN

          -  Serum amylase and lipase ≤1.0 x CL-ULN

          -  Left ventricular ejection fraction (LVEF) above the lower limit of normal (LLN) as
             assessed by multigated acquisition (MUGA) scan or echocardiography.

          -  Absence of any psychological, familial, sociological or geographical condition
             potentially hampering compliance with the study protocol and follow-up schedule; those
             conditions should be discussed with the patient before registration in the trial

          -  Before patient registration/randomization, written informed consent must be given
             according to ICH/GCP, and national/local regulations.

        Exclusion Criteria:

          -  Her2 neu positive tumor with IHC 3+ or FISH+

          -  Concurrent hormone therapy (tamoxifen, aromatase inhibitors, other hormone suppressing
             therapies) with SU11248.

          -  Concurrent treatment with hormonal replacement therapy

          -  Concurrent treatment with any other anti-cancer therapy. Bisphosphonates are allowed.

          -  Concurrent treatment with other experimental drugs. Participation in another clinical
             trial with any investigational not marketed drug within 20 days prior to study entry.
             Previous trials with antiangiogenic drugs is not allowed.

          -  Chronic treatment with steroids unless initiated > 6 months prior to study entry and
             at low dose (< 20 mg methylprednisolone daily or equivalent)

          -  Diagnosis of any second malignancy within the last 5 years, except for adequately
             treated basal cell or squamous cell skin cancer, or for in situ carcinoma of the
             cervix uteri.

          -  Any of the following within the 12 months prior to study drug administration:
             myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass
             graft, symptomatic congestive heart failure, cerebrovascular accident or transient
             ischemic attack, pulmonary embolism, deep vein thrombosis, or other thromboembolic
             event.

          -  Ongoing cardiac dysrhythmias of NCI CTCAE grade ≥2, atrial fibrillation of any grade,
             or prolongation of the QTc interval to >450 msec for males or >470 msec for females.

          -  Known human immunodeficiency virus (HIV) positivity or acquired immunodeficiency
             syndrome (AIDS)-related illness.

          -  Pregnancy or breastfeeding. Patients must be surgically sterile or be postmenopausal,
             or must agree to use effective contraception during the period of therapy. All female
             patients with reproductive potential must have a negative pregnancy test (serum or
             urine) within the 7 days prior to enrollment. The definition of effective
             contraception will be based on the judgment of the principal investigator or a
             designated associate.

          -  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.