A Phase II Study of Pazopanib in the Treatment of Surgically Unresectable or Metastatic Liposarcoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 9
- 主要终点
- 12-week Progression Free Rate
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness and safety of single agent pazopanib in subjects with unresectable or metastatic liposarcoma.
详细描述
This is a Phase II, multicenter, prospective, open label, single arm study. The primary endpoint of the study is progression-free rate as defined by Response Evaluation Criteria in Solid Tumors (RECIST) guidelines version 1.1 at week 12 after start of treatment. The secondary endpoints include overall progression-free survival (PFS), response rate (RR), duration of response, overall survival (OS), and toxicity assessment through the reporting of adverse events.
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
- •Written informed consent.
- •Age > or = to 18 years.
- •Histologically or cytologically confirmed high- or intermediate-grade liposarcoma (allowed subtypes include liposarcoma dedifferentiated, myxoid/round cell, pleomorphic, mixed-type, or not otherwise specified).
- •Surgically unresectable or metastatic disease.
- •Any number of prior treatment treatment regimens, including treatment naive subjects.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Measurable or evaluable (non-measurable) disease per RECIST guidelines version 1.
- •Subjects must have documented disease progression within the past 6 months.
- •Adequate organ system function determined within 14 days prior to first dose of study treatment.
- •Left ventricular ejection fraction (LVEF) > 50% of the institutional LLN within 28 days prior to the first dose of study treatment.
- •Females must be of either non-child bearing potential or have a negative pregnancy test within 7 days prior to the first dose of study treatment.
排除标准
- •Well differentiated liposarcoma.
- •Prior treatment with tyrosine kinase inhibitors (TKIs) or vascular endothelial growth factor (VEGF) inhibitors.
- •Prior malignancy (Note: subjects who have had another malignancy and have been disease-free for 3 years, or subjects with a history of completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma are eligible).
- •History or clinical evidence of central nervous system metastases or leptomeningeal carcinomatosis, unless previously treated, asymptomatic, and off steroids and anti-seizure medication for 6 months prior to first dose of study drug
- •Clinically significant gastrointestinal (GI) abnormalities that may increase the risk for GI bleeding.
- •Clinically significant GI abnormalities that may affect absorption of investigational product.
- •Presence of uncontrolled infection.
- •Corrected QT interval > 480 msecs using Bazett's formula.
- •History of certain cardiovascular conditions within the past 6 months.
- •Poorly controlled hypertension [defined as systolic blood pressure of > or = 140 mmHg or diastolic blood pressure > or = 90 mmHg].
- •History of cerebrovascular accident including transient ischemic attack, pulmonary embolism, or untreated deep vein thrombosis within the past 6 months.
- •Prior major surgery or trauma within 28 days prior to the first dose of study drug and/or presence of any non-healing wound, fracture, or ulcer.
- •Evidence of active bleeding or bleeding diathesis.
- •Known endobronchial lesions and/or lesions infiltrating major pulmonary vessels that increase the risk of pulmonary hemorrhage.
- •Hemoptysis in excess of 2.5 mL within 8 weeks of first dose of study drug.
- •Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject's safety, provision of informed consent, or compliance to study procedures.
- •Unable or unwilling to discontinue use of prohibited medications for at least 14 days or five half-lives of a drug, whichever is longer, prior to the first dose of study drug and for the duration of study treatment.
- •Radiation therapy, minor surgery, tumor embolization, chemotherapy, immunotherapy, biologic therapy, investigational therapy, or hormonal therapy within 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of study drug.
- •Administration of any non-oncologic investigational drug within 30 days or five half-lives (whichever is longer) prior to receiving the first dose of study drug.
- •Any ongoing toxicity from prior anti-cancer therapy that is > Grade 1 and/or that is progressing in severity, except alopecia.
- •Known immediate or delayed hypersensitivity reaction to idiosyncrasy to drugs chemically realted to pazopanib or excipients that contraindicates participation.
研究组 & 干预措施
pazopanib
Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle. Study treatment may continue until disease progression or unacceptable toxicity.
干预措施: pazopanib (Drug)
结局指标
主要结局
12-week Progression Free Rate
时间窗: Assessed after 12 weeks of study treatment
Progression will be as defined per Response Evaluation Criteria In Solid Tumors (RECIST) guidelines version 1.1. Subjects who remain under observation and progression free at 12 weeks will be defined as treatment successes. Subjects who progress per RECIST by 12 weeks or who drop out without evidence of progression prior to 12 weeks will be defined as treatment failures.Progression is defined using Response Evaluation Criteria in Solid Tumors (RECIST v1.1), as a \>=20% increase in the sum of diameters of target lesions, or a measurable increase in a non-target lesion, or the appearance of \>=1 new lesion.
次要结局
- Progression Free Survival (PFS)(Date of Consent until progression or death, up to 27 months)
- Best Overall Response(Date of consent until end of study treatment, up to 32 months)
- Duration of Response(Measure of the amount of time that the criteria for response per RECIST are first met until disease progression)
- Overall Survival (OS)(Date of Consent until death, up to 32 months)