EUCTR2004-004378-10-BE进行中（未招募）不适用
Multi-center, open-label, non-randomised phase II study to evaluate the activity and tolerability of GW786034 in patients with advanced and/or metastatic soft tissue sarcoma who have relapsed following standard therapies or for whom no standard therapy exists.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 148
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
- •- Histologically or cytologically confirmed high or intermediate grade
- •malignant soft tissue sarcoma; most malignant tumors of non organ origin,
- •as well as skin and uterine leiomyosarcoma are included
- •- Measurable disease (according to RECIST).
- •- Relapsed of refractory disease incurable by surgery or radiotherapy
- •- No more than one combination or two single agents chemotherapy
- •regimen for advanced disease; (neo)adjuvant therapy is not counted
- •towards this requirement
- •- No history of leptomeningeal or brain metastases
- •- At least 21 years of age
- •- WHO performance status 0 or 1
- •- Adequate bone marrow function (ANC>1.5 10**9/l, PLA>100 10**9/l
- •- Adequate hepatic function (bilirubin within normal range, SGOP/AST and
- •SGPT/ALT <= 2.5*UNL)
- •- Adequate renal function (creatinine clearance > 50 ml/min, calculated or
- •measured; urine protein excretion <= 500 mg/24h
- •- PT/INR/PTT within 1.2 UNL
- •- LVEF above the lower limit of normal for the institution, based on ECHO
- •or MUGA; no class II, III or IV heart failure (NYHA classification); a patient who has a history of class II heart failure and is asymptomatic on treatment may be considered eligible; no arterial or venous thrombosis, myocardial infarction, unstable angina,
- •cardiac angioplasty or stenting within the last 3 months
- •- No uncontrolled or poorly controlled hypertension (SBP >= 150 mm Hg,
- •DBP >=90 mm Hg). Initiation or adjustment of BP medications is permitted prior to study entry, provided that patient has 3 consecutive BP readings less than 150 / 90 mm Hg each separated by a minimum of 24 hrs.
- •These readings need to be collected prior to registration in the study.
- •- No therapeutic dose warfarin; low molecular weight heparin and prophylactic low dose warfarin are permitted.
- •- Able to swallow and retain oral medication
- •- Women should not be pregnant (negative serum pregnancy test at entry)
- •or lactating, and agree to use contraceptive methods (oral contraceptive are not allowed)
- •- before patient registration, Informed consent must be given.
- •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
- •The following tumor types are ineligible
- •- Malignant glomus tumors
- •- Embryonal rhabdomyosarcoma
- •- Chondrosarcoma
- •- Osteosarcoma
- •- Ewing tumors / PNET
- •- Gastro-intestinal stromal tumors
- •- Malignant solitary fibrous tumors
- •- Dermofibromatosis sarcoma protuberans
- •- Inflammatory myofibroblastic sarcoma
- •- Neuroblastoma
- •- Malignant mesothelioma
- •- Mixed mesodermal tumors of the uterus
研究者
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