EUCTR2017-003382-10-DE进行中（未招募）1 期
Quality of life in patients with non-adipocyte soft tissue sarcoma underpalliative chemotherapy or pazopanib – a randomized, controlled trial-PazoQoL - PazoQol
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- GWT-TUD GmbH
- 入组人数
- 150
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
- •The informed consent form must be signed before any study specific
- •tests or procedures are done
- •Male or female patients aged 18 years and older at the first screening
- •Histologically confirmed diagnosis of advanced or metastatic nonadipocyte
- •Suitable for treatment with pazopanib in an in-label prescription
- •Patients with a life expectancy of at least 6 months
- •ECOG performance status 0-2
- •Adequate organ function as given in Table 1
- •For patients with previous anthracycline therapy a normal heart
- •function needs to be documented with an LVEF of minimal 50%
- •(echocardiogram or MUGA scan)
- •Patients must be willing and able to fill in the QoL questionnaires
- •using a tablet PC
- •Ability to understand and follow study-related instructions
- •Confirmation of the subject's health insurance coverage prior to the
- •first visit
- •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 150
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 150
排除标准
- •Subjects are to be excluded from the study if they display any of the
- •following criteria:
- •Pretreatment with pazopanib
- •Contraindications according to the local SmPC of Votrient® (see
- •Appendix 1)
- •Patients having to following STS specific Tumors:
- •oadipocyte sarcoma including all subtypes
- •oall rhabdomyo sarcoma,
- •oChondro sarcoma
- •oOsteo sarcoma
- •oEwing-tumors,
- •oDermatofibrosarcoma protuberans
- •oInflammatory myofibroblastic sarcoma
- •oMalignant mesotheliom
- •oMixed mesenchymal and epidermal tumors of the uterus.
- •Other malignant underlying diseases with the exception of the
- •o Free of disease for at least three years
- •o Completely resected, non-melanoma skin cancer
- •o Successfully treated carcinoma in situ
- •o Patients with metastases of the central nervous system (CNS) at
- •screening, which are asymptomatic AND do not require treatment with
- •steroids or enzyme-inducing anticonvulsant drugs
- •o Patients with metastases of the CNS, which are already treated
- •(operation and/or radiotherapy, radiosurgery or gamma-knife)
- •Major surgery or trauma within 28 days before the first dose of
- •study medication and / or presence of a non-healing wound, fracture,
- •or ulcer (procedures like insertion of an ureteral stent are not regarded
- •as major surgery)
- •Clinical indications of an active bleeding or a bleeding diathesis
- •Known endobronchial lesions or lesions that infiltrate the large
- •pulmonary artery
- •Hemoptysis of > 2.5 mL within eight weeks before the first dose of
- •Existing uncontrolled infection
- •Heart rate-corrected QT-time according to the Fridericia´s-formula
- •(QTcF) = 450 ms in males and = 460 ms in females
- •History of one or more of the following cardiovascular diseases
- •within the last 6 months:
- •o Cardiac angioplasty or coronary stent
- •o Myocardial infarction
- •o Unstable angina pectoris
- •o Coronary artery bypass surgery
- •o Symptomatic peripheral arterial disease
- •Cardiac insufficiency NYHA functional class III or IV
- •Poorly controlled hypertension defined as systolic blood pressure =
- •140 mmHg or diastolic blood pressure = 90 mmHg. (Note: Start or
- •adjustment of antihypertensive medication prior to study entry is
- •allowed. Blood pressure should in this case be be stable for at least 2 weeks and re-evaluated at least
- •twice with a minimum distance of 1 hour. The average of all
- •measurements must be <140/90 to allow inclusion of the patient).
- •History of cerebrovascular disease, including transient ischemic
- 另有 16 项未显示
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