EUCTR2012-005428-14-IT进行中（未招募）1 期
A Phase II study on Trabectedin in advanced retroperitoneal leiomyosarcoma and well differentiated/dedifferentiated liposarcoma - TRAVE
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 95
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
- •- Persistent or locally relapsed and/or metastatic disease (in case of local disease, surgery may be technically feasible or not, but the clinical judgment must be that medical therapy is indicated)
- •- Pathology specimens available for centralized review
- •- Age = 18 years
- •- ECOG PS = 2
- •- One or more previous systemic treatments employing anthracyclines and ifosfamide (unless one or both are clinically contraindicated)
- •- Measurable disease, as defined by RECIST criteria
- •- A minimum of 3 weeks since any previous medical therapy
- •- Recovery from toxic effects of prior therapies to NCI CTC Grade 1 or lower
- •- Adequate haematological, renal and liver functions
- •- Ability and willingness to provide 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 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 55
排除标准
- •- Pregnant or breast-feeding women
- •- Prior exposure to trabectedin
- •- Peripheral neuropathy, Grade 2 or higher
- •- History of other malignancies (except for basal cell carcinoma or cervical carcinoma in situ, adequately treated), unless in remission for 5 years or more and judged of negligible potential of relapse
- •- Known central nervous system (CNS) metastases
- •- Active viral hepatitis or chronic liver disease
- •- Unstable cardiac condition, including congestive heart failure or angina pectoris, myocardial infarction within one year before enrolment, uncontrolled arterial hypertension or arrhythmias
- •- Active major infection
- •- Other serious concomitant illnesses
研究者
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