EUCTR2008-006007-23-GB进行中（未招募）1 期
A clinicopathological phase II study of axitinib in patients with advanced angiosarcoma and other soft tissue sarcomas - Axi-STS Trial, version 1
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 152
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
- •a)Pathologically confirmed Trojani intermediate or high grade soft tissue sarcoma, including: angiosarcoma, leiomyosarcoma, synovial sarcoma, other eligible subtypes (defined in protocol).
- •b)Locally advanced or metastatic disease incurable by surgery or radiotherapy.
- •c)Measurable disease according to RECIST criteria.
- •d)Evidence of objective disease progression in the past 6 months.
- •e)Patients ineligible for chemotherapy or who have received no more than 2 prior regimens.
- •f)Age > or = 16.
- •g)WHO performance status 0, 1 or 2.
- •h)At least 4 weeks from prior anticancer treatment or any surgery and full recovery from all AEs.
- •i)Adequate physiological function:
- •renal : calculated or measured creatinine clearance > or = 50 ml/min.
- •haematological: ANC > or = 1.5 x 109/L, platelets > or = 100 x 109/L, INR < or = 1.2.
- •hepatic: bilirubin within normal range, AST and ALT < or = 3 x upper limit of normal.
- •cardiac: LVEF (measured by ECHO or MUGA) within normal range.
- •j)Negative pregnancy test and agrees to comply with contraceptive measures.
- •k)Able to swallow oral medication.
- •Are the trial subjects under 18? yes
- •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
- •a)Ineligible pathological subtypes including: osteosarcoma, Ewings/PNET, chondrosarcoma, GIST, mesothelioma (further details in protocol).
- •b)Known central nervous system metastases.
- •c) Age <16.
- •d)Previous malignancies (except curatively treated non-melanoma skin cancer or carcinoma in situ of the cervix or breast) within the past 3 years.
- •e)Uncontrolled or poorly controlled hypertension: systolic BP > or = 150 mmHg or diastolic BP > or = 90 mmHg (further defined in protocol). Heart failure > or = NYHA class II.
- •f)Therapeutic dose warfarin. Low molecular weight heparin is permitted.
- •g)History of malabsorption or major gastrointestinal tract resection likely to affect study drug absorption.
- •h)Heart failure > or = NYHA class II.
- •i)History of hemoptysis > 2.5 ml of blood (1/2 teaspoonful)in any 24-hour period within prior 2 weeks of enrollment
- •j)Any of the following within the 12 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, deep vein thrombosis or pulmonary embolism.
- •k) Current use or anticipated need for treatment with drugs that are known CYP3A4 or CYP1A2 inducers.
- •l) Current use or anticipated need for treatment with drugs that are known potent CYP3A4 inhibitors.
- •m) Pregnancy or breastfeeding. Female patients must be surgically sterile or be postmenopausal, or must agree to use two effective contraception measures during the period of therapy which should be continued for 4 weeks after the last dose of trial therapy. Male patients must be surgically sterile or must agree to use effective contraception during the period of therapy which should be continued for 4 weeks after the last dose of trial therapy. Further details in protocol.
研究者
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