临床试验/NCT00669019

NCT00669019已完成2 期

A Phase 2 Study of AZD0530 in Metastatic Melanoma

National Cancer Institute (NCI)1 个研究点分布在 1 个国家目标入组 23 人开始时间: 2006年7月最近更新: 2014年5月21日

适应症

干预措施

试验速览

阶段: 2 期
状态: 已完成
发起方: National Cancer Institute (NCI)
入组人数: 23
试验地点: 1
主要终点: Objective Response Rate

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型: Interventional
分配方式: Na
干预模型: Single Group
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•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

排除标准

未提供

研究组 & 干预措施

Saracatinib

Experimental

Patients receive saracatinib 175 mg oral once daily in the absence of disease progression or unacceptable toxicity.

干预措施: saracatinib (Drug)

结局指标

主要结局

Objective Response Rate

时间窗: Up to 25 weeks

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.

次要结局

Progression-free Survival(Up to 2 years)

研究者

发起方

National Cancer Institute (NCI)

申办方类型

Nih

责任方

Sponsor

研究点 (1)

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