Saracatinib in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed By Surgery

Completed · Phase 2

Conditions studied: Recurrent Melanoma, Stage IIA Melanoma, Stage IIB Melanoma, Stage IIC Melanoma, Stage IV Melanoma

In brief

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

Key facts

Study ID

NCT00669019

Run by

National Cancer Institute (NCI)

People needed

23

Starts

2006-07-01

Expected to finish

2011-01-01

Last updated by the study team

2014-05-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• University of Chicago Comprehensive Cancer Center — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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