EUCTR2012-005846-39-DE进行中（未招募）1 期
Phase II, multicenter, open-label, single-arm trial in advanced and relapsed Angiosarcomas, to evaluate the efficacy of pazopanib (Votrient) in combination with standard of care treatment paclitaxel ( Evaluation of Votrient in angiosarcoma - EVA) - EVA (Evaluation of Votrient in angiosarcoma)
niversity of Heidelberg0 个研究点目标入组 44 人开始时间: 2014年3月12日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 44
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. Subjects must provide written informed consent prior to performance of study-specific procedures or assessments and must be willing to comply with treatment and follow-up.
- •Note: Procedures conducted as part of the subject’s routine clinical management (e.g., blood count, imaging studies) and obtained prior to signing informed consent may be utilized for screening or baseline purposes provided these procedures are conducted as specified in the protocol.
- •2. Age = 18 years
- •3. Life expectancy > 3 months
- •4. Ability to swallow tablets
- •5. Histological confirmed angiosarcoma, primary and secondary angiosarcoma (e.g. radiation-induced or angiosarcoma in chronical lymphedema) are eligible.
- •6. Tumor must be locally advanced (unresectable) or metastatic. A progression must be documented within a 6-month period prior to screening.
- •7. ECOG performance status = 2
- •8. At least one measurable skin lesion or one measurable radiological (CT or MRI) target lesion (RECIST 1.1)
- •9. Adequate organ system function as described in protocoll
- •10. A female is eligible to enter and participate in this study if she is either of non childbearing potential (defined in protocol) or childbearing potential with negativ pregnancy test within 2 weeks prior to the first dose of study drug and agrees to use adequate contraception (as defined in protocol) during the study and for 6 month after the last dose of study drug.
- •11. All sexually active male patients must agree to use adequate methods of birth control (see protocol) throughout the study and for 6 month after the last dose of study drug.
- •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 22
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 22
排除标准
- •1. Patients who need an active treatment for another malignant disease other than angiosarcoma
- •2. Prior treatment with a taxan within the last 12 months before study entry
- •3. History or clinical evidence of central nervous system (CNS) metastases or leptomeningeal sarcomatosis
- •4. Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding
- •5. Clinically significant gastrointestinal abnormalities that may affect absorption of investigational product
- •6. Presence of uncontrolled infection
- •7. QT prolongation interval (QTc) > 480 msecs
- •8. Clinically significant cardiovascular discorders within the past 6 months
- •9. Major surgery or trauma within 28 days prior to first dose of investigational product and/or presence of any non-healing wound, fracture, or ulcer
- •10. Poorly controlled hypertension (see protocol)
- •11. Evidence of active bleeding or bleeding diathesis
- •12. Known endobronchial lesions and/or lesions infiltrating major pulmonary vessels
- •13. Uncontrolled seizures, disorders of the CNS or psychiatric disorders which may put patient safety at risk, prevent giving informed consent or impact the patient's compliance with the use of study medication
- •14. Women who are pregnant or breast feeding
- •15. Patients who are not able or not willing to interrupt the intake of medications that are not allowed according to study protocol for at least 14 days before start of study medication and for the whole study period
- •16. Chemotherapy or radiotherapy within 14 days before start of study medication
- •17. Any ongoing toxicity from prior anti-cancer therapy that is > grade 1 and/or that is progressing in severity, except alopecia
- •Please note: Any treatment with Pazopanib before study entry is NOT allowed.
研究者
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