- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00669019
Saracatinib in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed By Surgery
A Phase 2 Study of AZD0530 in Metastatic Melanoma
Study Overview
Status
Conditions
Intervention / Treatment
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 will increase progression-free survival of these patients from 3 months to 4.5 months.
SECONDARY OBJECTIVES:
I. To determine whether this drug may inhibit the activation of peripheral blood T cells analyzed ex vivo.
OUTLINE:
Patients receive saracatinib orally (PO) once daily (QD) in the absence of disease progression or unacceptable toxicity.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Illinois
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Chicago, Illinois, United States, 60637-1470
- University of Chicago Comprehensive Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Saracatinib
Patients receive saracatinib 175 mg oral once daily in the absence of disease progression or unacceptable toxicity.
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective Response Rate
Time Frame: Up to 25 weeks
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Response will be evaluated in this study using the Response Evaluation Criteria in Solid Tumors (RECIST). A sum of the longest diameter (LD) for all target lesions will be calculated and reported as the baseline sum LD. The baseline sum LD will be used as reference by which to characterize the objective tumor response. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum LD; Objective response = CR + PR. CT scans will be performed at baseline and every 4-8 weeks while on study. |
Up to 25 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-free Survival
Time Frame: Up to 2 years
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Progression will be evaluated in this study using the RECIST criteria (the appearance of new lesions and/or at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study).
Progression-free survival time was calculated as the time from treatment start to date of progression or death, whichever comes first.
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Up to 2 years
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Thomas Gajewski, University of Chicago Comprehensive Cancer Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NCI-2009-00193
- N01CM62201 (U.S. NIH Grant/Contract)
- CDR0000594729 (Registry Identifier: PDQ (Physician Data Query))
- 16077A
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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