Clinical trial NCT00509587 (phase 2, status: completed)
Conditions: breast cancer, recurrent breast cancer, stage iv breast cancer
ICD codes: C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60, C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60, C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60
Drugs: pazopanib hydrochloride
SMILES: CN(C1=CC2=NN(C)C(C)=C2C=C1)C1=CC=NC(NC2=CC=C(C)C(=C2)S(N)(=O)=O)=N1
Eligibility criteria:

        Criteria:

          -  No prior bevacizumab

          -  Histologically or cytologically confirmed invasive breast carcinoma (recurrent or
             metastatic disease)

          -  Measurable disease, defined as >= 1 unidimensionally measurable lesion >= 20 mm by
             conventional techniques or >= 10 mm by spiral CT scan

          -  Patients who may still benefit from hormonal therapy are ineligible (patients with
             hormone receptor-positive breast cancer should have received appropriate sequential
             hormonal therapy for metastatic disease until disease progression)

          -  Patients with HER-2 positive disease who have not yet received trastuzumab
             (Herceptin®) to maximal benefit are ineligible (patients with disease progression
             during trastuzumab therapy are eligible)

          -  No known brain metastases

          -  ECOG performance status (PS) 0-1 or Karnofsky PS 60-100%

          -  Life expectancy > 12 weeks

          -  Absolute neutrophil count >= 1,500/mm³

          -  Platelets >=100,000/mm³

          -  Total bilirubin normal (exception made for patients with known Gilbert's disease)

          -  AST/ALT =< 2.5 times upper limit of normal (ULN)

          -  No proteinuria > +1 on two consecutive dipsticks taken >= 1 week apart

          -  PT/INR/PTT =< 1.2 times ULN

          -  No allergic reactions attributed to compounds of similar chemical or biologic
             composition to pazopanib or other study agents

          -  No QTc prolongation (defined as a QTc interval >= 500 msecs) or other significant ECG
             abnormalities

          -  No condition (e.g., gastrointestinal tract disease resulting in an inability to take
             oral medication or a requirement for IV alimentation, or active peptic ulcer disease)
             that would impair ability to swallow and retain study drug

          -  No poorly controlled hypertension (systolic blood pressure [BP] >= 140 mm Hg or
             diastolic BP >= 90 mm Hg) Initiation or adjustment of BP medication is allowed prior
             to study entry provided that the average of 3 BP readings prior to study entry is <
             140/90 mm Hg

          -  No serious or non-healing wound, ulcer, or bone fracture

          -  No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within
             the last 4 weeks

          -  No cerebrovascular accident within the last 6 months

          -  No myocardial infarction, cardiac arrhythmia, hospital admission for unstable angina
             within the last 12 weeks

          -  No venous thrombosis within the last 12 weeks

          -  No NYHA class III-IV heart failure Patients with a history of class II heart failure
             may be considered eligible provided they are asymptomatic on treatment

          -  No concurrent uncontrolled illness including, but not limited to, ongoing or active
             infection or psychiatric illness/social situations that would preclude study
             compliance

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C),
             radiotherapy, or surgery

          -  No cardiac angioplasty or stenting within the last 12 weeks

          -  No more than 1 prior chemotherapy regimen for recurrent disease

          -  No prior surgical procedures affecting absorption

          -  No CYP2C9 substrates during or for 1-2 weeks after completion of study treatment,
             including any of the following:

        Therapeutic warfarin Low molecular weight heparin or prophylactic low-dose warfarin are
        allowed

          -  No CYP2C9 substrates during or for 1-2 weeks after completion of study treatment,
             including any of the following:

               -  Erectile dysfunction agents: sildenafil, tadalafil, or vardenafil

               -  Antiarrhythmics: bepridil, flecainide, lidocaine, mexilitine, amiodarone, or
                  quinidine

               -  Immune modulators: cyclosporine, tacrolimus, or sirolimus

               -  Miscellaneous: theophylline, quetiapine, or risperidone

          -  No CYP2C9 substrates during or for 1-2 weeks after completion of study treatment,
             including any of the following:

               -  Oral hypoglycemics: glipizide, glyburide, or tolbutamide

               -  Ergot derivatives: dihydroergotamine, ergonovine, ergotamine, or methylergonovine

               -  Neuroleptics: pimozide

          -  No concurrent combination antiretroviral therapy for HIV-positive patients

          -  No other concurrent investigational agents

          -  No other concurrent anticancer therapy

          -  WBC >= 3,000/mm³

          -  No more than 2 prior palliative systemic chemotherapy regimens for de novo metastatic
             disease

          -  Creatinine normal OR creatinine clearance >= 60 mL/min

          -  At least 3 months since prior trastuzumab