A Phase II Trial of AZD0530 in Previously Treated Metastatic Pancreas Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 9
- 主要终点
- Six Month Survival
研究概览
简要总结
This phase II trial is studying how well saracatinib works in treating patients with previously treated metastatic pancreatic 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 determine the 6-month survival of biomarker-positive patients with previously treated metastatic pancreatic cancer receiving AZD0530 (saracatinib).
II. To determine the adverse events of this drug in these patients.
SECONDARY OBJECTIVES:
I. To evaluate the response rate in patients treated with this drug. II. To evaluate the overall survival of patients treated with this drug. III. To explore the pharmacodynamic effects of AZD0530 with optional tumor biopsies, pharmacokinetic studies, and positron emission tomography (PET) scans in a subset of patients.
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 pancreas
- •Metastatic disease
- •Received ≥ 1 prior chemotherapy regimen, preferably gemcitabine hydrochloride-based
- •Biomarker screening portion of study:
- •For subjects without archival tissue available (core biopsy or resection specimen; fine-needle aspirate samples only are not sufficient), must be willing to undergo a fresh needle-core biopsy of a safely biopsiable metastasis
- •No known brain metastases
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2 OR Karnofsky PS 60-100%
- •White blood cell (WBC) ≥ 3,000/mm³
- •Absolute neutrophil count (ANC) ≥ 1,500/mm³
- •Platelet count ≥ 100,000/mm³
- •Hemoglobin ≥ 9 g/dL
- •Total bilirubin < 1.5 times upper normal limit (ULN) (patients may have been shunted in order to achieve normal bilirubin level)
- •Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 2.5 times ULN (< 5 times ULN for patients with liver metastases)
- •Creatinine normal OR creatinine clearance ≥ 60 mL/min
- •Urine protein < 1,000 mg
- •Urine protein: creatinine ratio ≤ 1.0
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •Asymptomatic human immunodeficiency virus (HIV) allowed
- •Willingness to undergo 2 tumor biopsies
- •No history of allergic reactions attributed to compounds of similar chemical or biological composition to AZD0530
- •No prolonged QTc interval (i.e., ≥ 480 msec)
- •No other significant electrocardiogram (ECG) abnormalities
- •No poorly controlled hypertension (i.e., systolic blood pressure [BP] ≥ 150 mm Hg or diastolic BP ≥ 90 mm Hg)
- •No concurrent cardiac dysfunction including, but not limited to, any of the following:
- •History of ischemic heart disease
- •Myocardial infarction
- •Symptomatic congestive heart failure
- •Unstable angina pectoris
- •Cardiac arrhythmia
- •No condition (e.g., gastrointestinal tract disease resulting in an inability to take oral medication or requirement for intravenous (IV) alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease) that impairs ability to swallow AZD0530 tablets
- •No uncontrolled concurrent illness including, but not limited to any of the following:
- •Ongoing or active infection
- •Psychiatric illness or social situations that would limit compliance with study requirements
- •No other malignancy within the past 5 years, except curatively treated basal cell carcinoma of the skin or carcinoma in situ of the cervix
- •Recovered from all prior therapy (< grade 2) (excluding alopecia) administered within the past 4 weeks
- •At least 3 weeks since prior chemotherapy (6 weeks for carmustine or mitomycin)
- •At least 4 weeks since prior radiotherapy
- •More than 7 days since prior and no concurrent cytochrome P450 3A4 (CYP3A4)-active agents
- •No ongoing adverse events (excluding alopecia) due to chemotherapy or radiotherapy given more than 4 weeks prior to study
- •No other concurrent investigational agents
- •No concurrent combination antiretroviral therapy for HIV-positive patients
- •Concurrent low molecular weight heparin or full-dose coumadin allowed
- •Concurrent therapeutic hematopoietic growth factors allowed
排除标准
- 未提供
研究组 & 干预措施
Treatment (enzyme inhibitor therapy)
Patients receive saracatinib PO QD on days 1-28. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
干预措施: saracatinib (Drug)
Treatment (enzyme inhibitor therapy)
Patients receive saracatinib PO QD on days 1-28. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
干预措施: pharmacogenomic studies (Other)
Treatment (enzyme inhibitor therapy)
Patients receive saracatinib PO QD on days 1-28. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
干预措施: pharmacological study (Other)
Treatment (enzyme inhibitor therapy)
Patients receive saracatinib PO QD on days 1-28. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
干预措施: positron emission tomography (Procedure)
Treatment (enzyme inhibitor therapy)
Patients receive saracatinib PO QD on days 1-28. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
干预措施: fludeoxyglucose F 18 (Radiation)
Treatment (enzyme inhibitor therapy)
Patients receive saracatinib PO QD on days 1-28. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
干预措施: laboratory biomarker analysis (Other)
结局指标
主要结局
Six Month Survival
时间窗: Up to 6 months
The proportion of successes will be estimated by the number of surviving participants at 6 months divided by the total number of evaluable patients. A confidence interval for the 6-month survival rate was calculated using the exact binomial method.
次要结局
- Overall Survival(Up to 2 years)
- Confirmed Tumor Responses (Complete Response [CR] or Partial Response [PR])(Evaluated using the first 6 courses of treatment)
- Duration of Response(From the date first objective status is noted to be either a CR or PR to the date progression is documented, assessed up to 2 years)
- Progression-Free Survival(Progression and survival status assessed every month, up to 2 years)