临床试验/NCT00607594

NCT00607594已完成2 期

A Phase 2 Study of AZD0530 in Patients With Metastatic or Locally Advanced Gastric Carcinoma

National Cancer Institute (NCI)5 个研究点分布在 2 个国家目标入组 21 人开始时间: 2008年1月最近更新: 2018年8月23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: 21
试验地点: 5
主要终点: Objective Tumor Response (Defined as Partial [PR] or Complete Response [CR] by RECIST Criteria)

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 locally advanced or metastatic stomach or gastroesophageal junction cancer. 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 assess the objective disease control rate (i.e., partial or complete response as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria or stable disease for ≥ 16 weeks) in patients with locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction treated with AZD0530 (saracatinib).

SECONDARY OBJECTIVES:

I. To assess the median time to disease progression, median overall survival, and 1-year survival rate in these patients.

II. To assess the toxicity of AZD0530 in these patients. III. To evaluate potential predictive markers by assessing pretreatment intratumoral levels of src, Y419 phospho-src (P-Src), and c-terminal src kinase (Csk) in archival tumor biopsies.

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 adenocarcinoma of the stomach or gastroesophageal junction (GEJ)
•Tumors of the GEJ must be sub-specified as type I, II, or III using the Siewert classification
•Metastatic or locally advanced disease
•Patients with local/regional disease only, must have unresectable 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 > 3 months
•Platelet count ≥ 100,000/mm³
•Leukocytes ≥ 3,000/mm³
•Absolute neutrophil count ≥ 1,500/mm³
•Hemoglobin > 9 g/dL
•Total bilirubin normal
•Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 2.5 times upper limit of normal
•Creatinine normal OR creatinine clearance ≥ 60 mL/min
•Urine protein creatinine ratio < 1.0 OR urine protein < 1,000 mg by 24-hour urine collection

排除标准

•Not pregnant or nursing
•Negative pregnancy test
•Fertile patients must use effective contraception
•No condition that potentially impairs the ability to swallow or absorb AZD0530, including any of the following:
•Gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation
•Active peptic ulcer disease
•Short gut syndrome
•Malabsorption syndrome of any type
•Total or partial bowel obstruction
•Inability to tolerate oral medications
•No history of allergic reactions attributed to compounds of similar chemical or biologic composition to AZD0530
•No QTc prolongation (defined as a QTc interval ≥ 460 msec) or other significant electrocardiogram (ECG) abnormalities
•No poorly controlled hypertension (i.e., systolic blood pressure [BP] ≥ 140 mm Hg or diastolic BP ≥ 90 mm Hg)
•No history of ischemic heart disease, including myocardial infarction
•No concurrent cardiac dysfunction including, but not limited to, any of the following:
•Symptomatic congestive heart failure
•Unstable angina pectoris
•Cardiac arrhythmia
•No other concurrent uncontrolled illness, including ongoing or active infection or psychiatric illness/social situations, that would limit compliance with study requirements
•Prior chemotherapy allowed provided it was administered as part of initial curative intent therapy (i.e., neoadjuvant therapy, adjuvant therapy and/or concurrently with radiotherapy) in combination with surgery
•At least 4 weeks since prior chemotherapy
•At least 4 weeks since prior and no more than 1 line of palliative chemotherapy for advanced disease
•At least 4 weeks since prior radiotherapy and recovered
•At least 4 weeks since prior major surgery and recovered
•No cytochrome 450 3A4 (CYP3A4) active agents or substances for ≥ 7 days before, during, and for ≥ 7 days after completion of study treatment
•No other concurrent investigational agents
•No other concurrent anticancer therapy
•No concurrent combination antiretroviral therapy for human immunodeficiency virus (HIV)-positive patients

研究组 & 干预措施

Treatment (kinase inhibitor therapy)

Experimental

Patients receive saracatinib PO, at a dose of 175 mg QD in the absence of disease progression or unacceptable toxicity.

干预措施: saracatinib (Drug)

结局指标

主要结局

Objective Tumor Response (Defined as Partial [PR] or Complete Response [CR] by RECIST Criteria)

时间窗: Every 2 weeks for the first 4 weeks, and then every 4-8 weeks thereafter, for at least 16 weeks up to 37 weeks

PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. CR is defined as disappearance of all non-target lesions and normalization of tumor marker level.

Prolonged Stable Disease Rate (Defined as Stable Disease for ≥ 16 Weeks)

时间窗: Every 2 weeks for the first 4 weeks, and then every 4-8 weeks thereafter, for at least 16 weeks up to 37 weeks

次要结局

Time to Progression(Up to 1 year (median, 6 month, 1-year))
Progression-free Survival(Measured from the date of enrollment to progression, death or last contact, or last tumor assessment before the start of further anti-tumor therapy)
Median Survival(Up to 1 year)
Overall Survival(Up to 1 year (median, 6 months, and 1 year))
Highest Grade Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Version 3.0.(Weekly during treatment)
Patient Tolerability(Weekly during treatment)
Association Between Correlative Markers and Clinical Outcomes(At baseline, 6 months, and then at 1 year)

研究者

发起方

National Cancer Institute (NCI)

申办方类型

Nih

责任方

Sponsor

研究点 (5)

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