Saracatinib in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed By Surgery
Condition: Recurrent Melanoma; Stage IIA Melanoma; Stage IIB Melanoma; Stage IIC Melanoma; Stage IV Melanoma
MeSH terms: Melanoma
Intervention: saracatinib
Intervention MeSH terms: Saracatinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial is studying how well saracatinib works in treating patients with stage
      III or stage IV melanoma that cannot be removed by surgery. Saracatinib may stop the growth
      of tumor cells by blocking some of the enzymes needed for cell growth
    

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