NCT00459862已完成2 期
Phase II Study of GW786034 in Patients With Malignant Pleural Mesothelioma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Proportion of Evaluable Participants Who Are Progression-free at 6 Months Based on the Response Evaluation Criteria for Solid Tumors (RECIST)
研究概览
简要总结
This phase II trial is studying the side effects and how well pazopanib works in treating patients with malignant pleural mesothelioma. Pazopanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
详细描述
PRIMARY OBJECTIVES:
I. Determine the effect of pazopanib hydrochloride on the proportion of patients with malignant pleural mesothelioma who are progression-free at 6 months based on the RECIST criteria.
II. Determine the clinical toxicities of this drug in this patient population.
SECONDARY OBJECTIVES:
I. Determine the objective tumor response status in these patients as measured by the RECIST criteria or the modified RECIST criteria.
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 malignant pleural mesothelioma:
- •Measurable disease
- •No progressive disease inside or outside of any prior radiation field
- •No symptomatic, untreated, or uncontrolled CNS metastases
- •Patients with CNS metastases treated with whole brain radiation (WBRT) may be enrolled after completion of WBRT
- •Patients may begin study therapy as early as the next day after completion of WBRT
- •ECOG performance status 0-2
- •Life expectancy >= 12 weeks
- •ANC >=1,500/mm^3
- •Platelet count >= 100,000/mm^3
- •WBC >= 3,000/mm^3
- •Bilirubin =< 1.5 times upper limit of normal (ULN)
- •AST and ALT =< 2.5 times ULN
- •Alkaline phosphatase =< 2.5 times ULN
- •Creatinine =< 1.5 times ULN or creatinine clearance >= 50 mL/min
- •Proteinuria =< 1+ on 2 consecutive dipsticks taken >= 1 week apart
- •No condition that impairs ability to swallow and retain study drug tablets including, but not limited to, any of the following:
- •Gastrointestinal tract disease resulting in an inability to take oral medication
- •Requirement for IV alimentation
- •Prior surgical procedures affecting absorption
- •Active peptic ulcer disease
- •No other primary malignancy except for carcinoma in situ of the cervix or nonmelanomatous skin cancer, unless that prior malignancy was diagnosed and definitively treated ≥ 5 years ago with no subsequent evidence of recurrence
- •Patients with a history of low-grade (Gleason score =< 6) localized prostate cancer are eligible even if diagnosed within the past 5 years
- •No history of allergic reactions attributed to compounds of similar chemical or biological composition to pazopanib hydrochloride or other agents used in the study
- •None of the following concurrent severe and/or uncontrolled medical conditions:
- •Serious or nonhealing wound, ulcer, or bone fracture
- •Abdominal fistula, diverticulosis, gastrointestinal perforation, or intra-abdominal abscess within the past 28 days
- •Poorly controlled diabetes
- •Interstitial pneumonia
- •Extensive and symptomatic interstitial fibrosis of the lung
- •No cardiovascular illness or complication, including any of the following:
- •Any history of cerebrovascular accident within the past 6 months
- •History of myocardial infarction (prior electrocardiographic evidence of myocardial injury)
- •History of cardiac arrhythmia (prior electrocardiographic evidence of abnormal heart rhythm)
- •Admission for unstable angina
- •Cardiac angioplasty or stenting within the past 12 months
- •NYHA class III-IV heart failure
- •Asymptomatic NYHA class II heart failure allowed
- •QTc prolongation (defined as a QTc interval ≥ 500 msecs) or other significant electrocardiogram abnormalities
- •Venous thrombosis within the past 12 weeks
- •No ancillary therapy considered investigational within the past 4 weeks
- •No symptomatic, untreated, or uncontrolled seizure disorder
- •No uncontrolled intercurrent illness including, but not limited to, ongoing or active infection or psychiatric illness/social situations that would limit study compliance
- •No significant traumatic injury within the past 4 weeks
- •No more than 1 prior systemic therapy for malignant pleural mesothelioma
- •No major surgery (i.e., laparotomy) or open biopsy within the past 4 weeks
- •Insertion of a vascular access device is not considered major or minor surgery
- •No minor surgery within the past 2 weeks
- •Insertion of a vascular access device is not considered major or minor surgery
- •Prior palliative radiotherapy allowed
- 另有 13 项未显示
排除标准
- 未提供
研究组 & 干预措施
Arm I
Experimental
Patients receive 800 mg oral pazopanib hydrochloride once daily on days 1-21. Treatment repeats every 21 days for 2 years in the absence of disease progression or unacceptable toxicity.
干预措施: laboratory biomarker analysis (Other)
Arm I
Experimental
Patients receive 800 mg oral pazopanib hydrochloride once daily on days 1-21. Treatment repeats every 21 days for 2 years in the absence of disease progression or unacceptable toxicity.
干预措施: pazopanib hydrochloride (Drug)
结局指标
主要结局
Proportion of Evaluable Participants Who Are Progression-free at 6 Months Based on the Response Evaluation Criteria for Solid Tumors (RECIST)
时间窗: 6 months
The proportion of patients who are progression-free at 6 months is calculated by dividing the number of evaluable participants who are progression-free at 6 months based on the Response Evaluation Criteria for Solid Tumors (RECIST) by the total number of evaluable participants.
次要结局
- Progression-free Survival Assessed by RECIST(From study enrollment to the first date of disease progression or death as a result of any cause, whichever occurs first, up to 3 years)
- Determine the Clinical Toxicities of This Drug in This Participant Population.(Participants will be evaluated every cycle during treatment)
- Overall Response Rate(Participants will be evaluated every cycle during treatment, up to 2 years)
- Overall Survival(From study enrollment to time of death from any cause or censored at last follow-up, up to 3 years)
- Overall Best Response of Target Lesions to Pazopanib in Patients With MPM Based on the RECIST.(From study enrollment to the first date of disease progression)
研究者
研究点 (1)
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