ACTRN12607000107426进行中（未招募）不适用
A randomised phase II study to determine the safety and efficacy of PI-88 plus Dacarbazine compared to Dacarbazine alone in Patients with Metastatic Melanoma
Progen Pharmaceuticals Ltd0 个研究点目标入组 114 人开始时间: 2007年2月6日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 114
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 ot stated（—）
- 性别
- All
入选标准
- •1.Histologically proven metastatic melanoma2. surgery not feasible or inappropriate.3. measurable disease.4. voluntary written informed consent 5.Eastern Cooperative Oncology Group performance score 0-1. 6. at least 3 month life expectancy7. acceptable renal, liver and haematopoetic function.
排除标准
- •1. Central Nervous System(CNS) involvement, brain or meningeal metastases2. occular melanoma3. clinically significant non malignant disease.4. Prior or co existent malignant disease5. prior chemotherapy6. prior treatment with vaccines, biological response modifiers or radiotherapy or major surgery within the previous 4 weeks7. concomitant use of aspirin, Non Steroidal antiinflammatory drugs (NSAIDs), heaprin, low molecular weight heparin, warfarin, anti platelet drugs8. heparin or low molecular weight heparin in the previous 2 weeks.9. abnormal bleeding tendancy, history of Gastrointestinal bleeding in past 2 years, Irritable bowel sydrome.10. history of cardiac problems in past 3 months11. women who are pregnant, breast feeding or women in whom pregnacy cannot be excluded.12. allergy to anti coagulants or thrombolytic agents13. history of autoimmune bleeding disorders or evidence of Anti Heparin antibodies14. uncontrolled infection within past 4 weeks15. non compliant patients.
研究者
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