ACTRN12606000099527尚未招募2 期
An Open Label, Multi Centre, Phase II Study to Evaluate the Safety and Efficacy of Coramsine Injection in Patients with Renal Cell Carcinoma
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 56
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
- Non-randomised 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 confirmed diagnosis of non-resectable clear cell or papillary type Renal Cell Carcinoma. 2. Patients with bi-dimensionally measurable disease according to RECIST criteria on CT or MRI scanning. 3. Patients who are able and willing to provide written informed consent to participate in the study. 4. Patients with adequate haematological, hepatic and renal function. 5. ECOG performance status of 0-2. 6. Life expectancy of at least 16 weeks. 7. Must agree to the use of an adequate form of contraception. Negative pregnancy test in female patients of childbearing potential.
排除标准
- •1. Diagnosis with Sarcomatoid, Chromophobe, Collecting duct or Unclassified Renal Cell Carcinoma. 2. Patients with an active infection requiring oral or intravenous antibiotics. 3. Patients with significant cardiac or pulmonary disease or other significant medical condition which could impair the ability of the patient to participate. 4. Patients with recent (<6 months) peptic ulcerations or upper GI bleeding. 5. Pregnant or lactating women. 6. Patients with reactions to the Solanum species. 7. Active brain or other CNS metastases. 8. Unwilling or unable to have a venous access device. 9. Any other active malignancy. 10. Patients must not have had any radiotherapy for 3 weeks prior to entering the study and must be fully recovered from any acute effects. 11. Patients must not have had any prior chemotherapy for RCC (prior cytokines, vaccines, antiangiogenic agents or signal transduction agents are permitted). 12. Patients must not have had any other tumour treatment medications for 30 days prior to entering the study. 13. Patients must not be actively receiving any other investigational therapy, nor received any experimental agents within the previous 30 days. 14. Any other medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent.
研究者
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