Clinical trial NCT00669019 (phase 2, status: completed)
Conditions: recurrent melanoma, stage iia melanoma, stage iib melanoma, stage iic melanoma, stage iv melanoma
ICD codes: G47.13, J01.41, K11.22, K12.0, N96, F33.8, G03.2, C43.0, C43.31, D03.9, C43.51, C43.9, D03.0, C43.4
Drugs: saracatinib
SMILES: CN1CCN(CCOC2=CC3=C(C(NC4=C(Cl)C=CC5=C4OCO5)=NC=N3)C(OC3CCOCC3)=C2)CC1
Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed metastatic melanoma

               -  Stage IV or unresectable stage III disease

          -  Measurable disease, defined as ≥ 1 lesion that can be accurately measured in ≥ 1
             dimension (longest diameter to be recorded) as ≥ 20 mm by conventional techniques or
             as ≥ 10 mm by spiral computed tomography (CT) scan

          -  No known brain metastases

          -  Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2 OR Karnofsky PS
             60-100%

          -  Life expectancy > 12 weeks

          -  White blood cell (WBC) ≥ 3,000/mcL

          -  Absolute neutrophil count (ANC) ≥ 1,500/mcL

          -  Platelet count ≥ 100,000/mcL

          -  Hemoglobin ≥ 9 g/dL

          -  Total bilirubin normal

          -  Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times upper
             limit of normal

          -  Creatinine normal OR creatinine clearance ≥ 60 mL/min

          -  Proteinuria ≤ 1+ by dipstick OR 24-hour urine protein ≤ 1 g

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception prior to study until completion of
             study treatment

          -  No history of allergic reactions attributed to compounds of similar chemical or
             biologic composition to AZD0530

          -  No QTc prolongation (defined as a QTc interval ≥ 480 msecs) or other significant
             electrocardiogram (ECG) abnormalities

          -  No poorly controlled hypertension (e.g., systolic blood pressure [BP] of ≥ 140 mm Hg
             or diastolic BP of ≥ 90 mm Hg)

          -  No condition (e.g., gastrointestinal tract disease resulting in an inability to take
             oral medication or a requirement for IV alimentation), prior surgical procedures
             affecting absorption, or active peptic ulcer disease that impairs the ability to
             swallow AZD0530 tablets

          -  No intercurrent cardiac dysfunction including, but not limited to, any of the
             following:

               -  Symptomatic congestive heart failure

               -  Unstable angina pectoris

               -  Cardiac arrhythmia

          -  No recent history of ischemic heart disease including myocardial infarction

          -  No uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection or psychiatric illness/social situations that would limit compliance with
             study requirements

          -  No other malignancy within the past 5 years, except definitively treated, localized,
             nonmelanoma skin cancer or low-grade cervical neoplasm

          -  At least 4 weeks since prior and no more than one prior treatment regimen for advanced
             disease

          -  No prior kinase inhibitor with activity against Src kinases for metastatic melanoma

          -  More than 4 weeks since prior luteinizing hormone-releasing hormone agonists

          -  No concurrent combination antiretroviral therapy for human immunodeficiency virus
             (HIV)-positive patients

          -  No concurrent prohibited cytochrome P450 3A4 (CYP3A4)-active agents or substances

               -  Prohibited drugs should be discontinued 7 days prior to the administration of the
                  first dose of AZD0530 and for 7 days following discontinuation of AZD0530

          -  No other concurrent investigational agents or commercial therapies