EUCTR2008-001307-33-DK进行中（未招募）不适用
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. - PALETTE
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 360
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1) Histological evidence of high or intermediate grade of STS. Eligible tumor types are listed in the protocol
- •2) Confirmed disease progression by RECIST within the past 6 months prior to study enrolment. or within 12 months if only received prior systemic (neo)–adjuvant therapy
- •3) Metastatic disease
- •4) Measurable disease according to RECIST
- •5) Patients may have received a maximum of 4 prior lines of systemic therapies for advanced disease of which no more than two lines should be combination regimens. (neo)adjuvant/maintenance treatments are not counted for this criterion
- •Last dose of prior therapy can be given up to 14 days prior to starting the study; all ongoing toxicity from prior anti-cancer therapy are grade 1 (except alopecia) or have resolved.
- •patients whose disease has progressed on or after anthracycline based regimen
- •Patients whose disease has progressed on or after available standard chemotherapies at the treating institution except if medically contraindicated or refused by the patient
- •6) WHO PS 0-1
- •7) adequate bone marrow, coagulation, liver and renal function
- •8) Clinically normal cardiac function based on the institutional lower limit of normal (LVEF assessed by MUGA or ECHO) and normal 12 lead ECG (no prolongation of corrected QT interval (QTc) > 480 msecs) less than 14 days prior to treatment start and no history of any one or more of the cardiovascular conditions listed in the protocol within the past 6 months
- •10) Contraception
- •11) Written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1) Previous treatment with inhibitors of angiogenesis and/or VEGF or VEGFR-targeting agents. mTOR inhibitors are not considered as inhibitors of as inhibitors of angiogenesis
- •2) Known history of central nervous system metastases or leptomeningeal tumor spread
- •3) Prior history of malignancies other than sarcoma (exception noted in the protocol)
- •4) Ongoing toxicity from prior anti-cancer therapy > Grade 1 (except alopecia) and/or that is progressing in severity
- •5) Concurrent anti-cancer therapy including: chemotherapy, immunotherapy, biologic therapy, investigational therapy, radiotherapy, targeted agents or hormonal therapy within 14 days or five half-lives of a drug prior to the first dose of study medication and until 15 days after the last dose of study medication
- •6) Use of any investigational agent during study treatment and until 15 days after the last dose of study medication
- •7) Poorly controlled hypertension defined at baseline as blood pressure (BP) >150/90
- •8) Cerebrovascular accident at any time in the past, transient ischemic attack in the past 6 months, deep venous thrombosis (DVT) or a pulmonary embolism in the past 6 months; note: patients with recent DVT who have been treated with therapeutic anti-coagulating agents and remained stable for at least 6 weeks are eligible
- •9) History of clinically significant gastrointestinal disorders
- •10) Endobronchial lesions and/or lesions infiltrating major pulmonary vessels
- •11) Evidence of active bleeding or bleeding diathesis
- •12) Hemoptysis within 6 weeks prior to first dose of study drug
- •13) Prior major surgery or trauma within 28 days prior to first dose of study drug and/or presence of any non-healing wound, fracture, or ulcer
- •14) Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to pazopanib
研究者
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