Status:
COMPLETED
Saracatinib in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed By Surgery
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Recurrent Melanoma
Stage IIA Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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...
Detailed Description
PRIMARY OBJECTIVES: I. To determine whether the Src kinase inhibitor, AZD0530 (saracatinib), has single agent clinical activity in patients with advanced melanoma. II. To determine whether this drug...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00669019
Start Date
July 1 2006
End Date
January 1 2011
Last Update
May 21 2014
Active Locations (1)
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1
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States, 60637-1470