NCT00753688已完成3 期
A Randomized Double Blind Phase III Trial of Pazopanib Versus Placebo in Patients With Soft Tissue Sarcoma Whose Disease Has Progressed During or Following Prior Therapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 369
- 试验地点
- 1
- 主要终点
- Progression-free Survival (PFS)
研究概览
简要总结
A randomized double blind phase III trial of Pazopanib versus placebo in patients with soft tissue sarcoma whose disease has progressed during or following prior therapy
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- 未提供
排除标准
- •High or intermediate grade of soft tissue sarcoma; Low grade tumours allowed provided there is disease progression.
- •Metastatic and measurable disease (RECIST);
- •Subjects can have received maximum of 4 prior lines of systemic therapies (including up to 2 combination regimens) for advanced disease. (Neo) adjuvant/maintenance treatments are not counted for this criterion;
- •Last dose of prior therapy can be given upto 14 days prior to start of study if all ongoing toxicity from prior anticancer therapy are grade 1 or resolved (except alopecia).
- •Must have failed anthracycline-based therapy and available standard chemotherapies at the treating institution except if medically contraindicated or refused by patient;
- •No treatment with anti-angiogenesis inhibitors;
- •Age > 18 years
- •WHO PS 0-1;
- •No leptomeningeal or brain metastases, normal bone marrow, liver, renal and cardiac functions;
- •No prior history of malignancies other than sarcoma (except for basal cell or squamous cell carcinoma of the skin or carcinoma in-situ of the cervix or breast or the patient has been free of any other malignancies for > 3 years)
- •Adequate bone marrow function; adequate blood clotting results; adequate hepatic and renal function;
- •No poorly controlled hypertension;
- •Clinically normal cardiac function;
- •No clinically significant gastrointestinal abnormalities including malabsorption syndrome, major resection of the stomach or small bowel that could affect the absorption of study drug, active peptic ulcer disease, inflammatory bowel disease, ulcerative colitis, or other gastrointestinal conditions with increased risk of perforation, history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days prior to beginning study treatment.
- •No cerebrovascular accidents 1
- •No transient ischemic attack, deep vein thrombosis or pulmonary embolism within past six months;
- •No active bleeding or bleeding diathesis;
- •No hemoptysis within six weeks of study drug;
- •No major surgery or trauma within 28 days of therapy treatment;
- •Concomitant medication restriction;
- •No known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to pazopanib
- •Ability to swallow & retain oral medication
- •Adequate contraception must be used;
- •No Psychological familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be assessed with the patient before randomization in the trial.
研究组 & 干预措施
PLACEBO
Placebo Comparator
matching placebo 800 mg once daily orally
干预措施: Placebo (Drug)
PAZOPANIB
Experimental
800 mg once daily orally
干预措施: PAZOPANIB (Drug)
结局指标
主要结局
Progression-free Survival (PFS)
时间窗: From the date of randomization until the date of the first documented radiological progression or date of death from any cause, whichever came first (assessed for an average of 10 months)
PFS was defined as the time interval between the date of randomization and the earliest date of either disease progression or death due to any cause. The diagnosis of progression was based on tumor measurements, according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 criteria, by independent radiologic assessment. The Kaplan-Meier method was used for PFS estimates.
次要结局
- Overall Survival (OS)(From the date of randomization until 215 deaths (assessed for an average of 12 months))
- Number of Participants in the Indicated Categories for Overall Response Assessed by an Independent Radiologist and the Investigator(From the start of treatment until disease progression (assessed for an average of 10 months))
- Time to Response Assessed by an Independent Radiologist and the Investigator(From the date of randomization until the date of the first documented evidence of CR or PR (assessed for an average of 10 months))
- Duration of Response Assessed by the Independent Radiologist and the Investigator(From the date of randomization until the date of the first documented evidence of CR or PR (assessed for an average of 10 months))
- PFS in the Indicated Histology Subgroups of Soft Tissue Sarcoma (STS)(From the date of randomization until the date of the first documented progression or the date of death from any cause, whichever came first (assessed for an average of 10 months))
- Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)(Baseline, Day 8, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 88, 96, and 104)
- Change From Baseline in Heart Rate(Baseline, Day 8, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 88, 96, and 104)
- Number of Participants With the Indicated Grade Shifts From Baseline Grade for Hemoglobin Level, Lymphocyte Count, White Blood Cell Count, Neutrophil Count, and Platelet Count(From baseline (Day 1) until study drug discontinuation or end of treatment (assessed for an average of 20 weeks))
- Number of Participants With the Indicated Grade Shifts From Baseline Grade for Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Albumin, Creatinine, Hyper/Hypoglycemia, Hyper/Hypokalemia, Hyper/Hyponatremia, and Total Bilirubin(From baseline (Day 1) until study drug discontinuation or end of treatment (assessed for an average of 20 weeks))
- Number of Participants With the Indicated Absolute Percent Change From Baseline (BL) in Left Ventricular Ejection Fraction (LVEF) at Any Time Post-BL (Worst Case On-therapy)(Baseline (within 14 days of the first dose of study drug) and any time post-baseline until study drug discontinuation or end of treatment (assessed for an average of 20 weeks))
研究者
研究点 (1)
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