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

Stage IV Melanoma Clinical Trial

Official title:

A Phase 2 Study of AZD0530 in Metastatic Melanoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00669019
• Other study ID #: NCI-2009-00193
• Secondary ID: N01CM62201CDR000
• Status: Completed
• Phase: Phase 2
• First received: April 26, 2008
• Last updated: May 6, 2014
• Start date: July 2006
• Est. completion date: January 2011

Study information

• Verified date: January 2014
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Melanoma
• Recurrent Melanoma
• Stage IIA Melanoma
• Stage IIB Melanoma
• Stage IIC Melanoma
• Stage IV Melanoma

Intervention

Drug:
• saracatinib

Locations

Country	Name	City	State
United States	University of Chicago Comprehensive Cancer Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate	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	No
Secondary	Progression-free Survival	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.	Up to 2 years	No