EUCTR2008-001307-33-GB进行中（未招募）1 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. - PALETTE
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
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
入选标准
- •Inclusion Criterion 1 revised (note - section re-organized) • Histological evidence of high or intermediate grade of STS. Eligible tumor types are listed in the protocol • 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 • Metastatic disease • Measurable disease according to RECIST • 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 • WHO PS 0-1 • adequate bone marrow, coagulation, liver and renal function • 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 • Contraception • 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
- •Exclusion Criterion 3 revised (note - section re-organized) • 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 • Known history of central nervous system metastases or leptomeningeal tumor spread • Prior history of malignancies other than sarcoma (exception noted in the protocol) • Ongoing toxicity from prior anti-cancer therapy > Grade 1 (except alopecia) and/or that is progressing in severity • 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 • Use of any investigational agent during study treatment and until 15 days after the last dose of study medication • Poorly controlled hypertension defined at baseline as blood pressure (BP) >150/90 • 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 • History of clinically significant gastrointestinal disorders • Endobronchial lesions and/or lesions infiltrating major pulmonary vessels • Evidence of active bleeding or bleeding diathesis • Hemoptysis within 6 weeks prior to first dose of study drug • 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 • Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to pazopanib
研究者
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