NCT01330966已完成2 期
A Phase II Study of Pazopanib in the Treatment of Surgically Unresectable or Metastatic Chondrosarcoma
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
- 47
- 试验地点
- 7
- 主要终点
- Disease Control at Week 16
研究概览
简要总结
The purpose of this study is to determine the effectiveness and safety of single agent pazopanib in subjects with chondrosarcoma.
详细描述
This research study is being conducted in adult subjects with a type of bone cancer called chondrosarcoma that has spread to other parts of the body and is not able to be removed with surgery. There is only one study drug that will be used in this study. It is a drug that interferes with cell communication and growth, taken orally. The study drug is called pazopanib.
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 confirmed diagnosis of conventional chondrosarcoma of any grade.
- •Surgically unresectable or metastatic disease.
- •Any number of prior treatment regimens, including treatment naive subjects. Prior treatment with tyrosine kinase inhibitors is permitted.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or
- •Measurable or evaluable (non-measurable) disease per RECIST guidelines version 1.
- •Adequate organ system function determined within 14 days prior to first dose of study treatment.
- •Left ventricular ejection fraction > 50% or the institutional LLN within 28 days prior to the first dose of study treatment.
- •Females must either be of non-child bearing potential or have a negative serum pregnancy test within 7 days prior to the first dose of study treatment.
排除标准
- •Prior treatment with pazopanib.
- •Mesenchymal, dedifferentiated, and extraskeletal myxoid chondrosarcoma subtypes.
- •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 (CNS) 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 of > or = 90 mmHg].
- •History of cerebrovascular accident including transient ischemic attack, pulmonary embolism, or untreated deep venous 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, surgery (except major 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.
- •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 or idiosyncrasy to drugs chemically related to pazopanib or excipients that contraindicates participation.
研究组 & 干预措施
pazopanib
Experimental
Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle.
干预措施: pazopanib (Drug)
结局指标
主要结局
Disease Control at Week 16
时间窗: Assessed at week 16 of study treatment
Disease control at week 16 defined as complete response (CR), Disappearance of all target lesions; plus partial response (PR), At least a 30% decrease in the sum of diameters of the target lesions taking as reference the Baseline sum diameters; plus stable disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference the smallest sum diameters while on the study; where tumor response is defined by RECIST (Response Evaluation Criteria in Solid Tumors) guidelines version 1.1. Repeat radiologic imaging is performed after every 2 cycles of treatment (approximately every 8 weeks).
次要结局
- Progression Free Survival (PFS)(Cycle 1 day 1 until the subject experiences disease progression)
- Overall Survival (OS)(Cycle 1 day 1 until 6 months after end of treatment, is lost to follow-up, or withdraws consent)
研究者
研究点 (7)
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