ISRCTN34237167已完成3 期
A multicentre, randomised, double-blind study of dacarbazine with or without Genasense® in chemotherapy-naïve subjects with advanced melanoma and low lactate dehydrogenase (LDH) (The AGENDA Trial)
Genta Incorporated (USA)0 个研究点目标入组 300 人开始时间: 2008年6月9日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 300
研究概览
简要总结
2007 Abstract: Bedikian AY, Agarwala SS, Gilles E, Itri L, Kay R, Garbe C. The AGENDA Study: A randomized, double-blind study of Genasense plus dacarbazine (DTIC) in chemotherapy-naïve subjects with advanced melanoma and low LDH. Pigment Cell Res. 2007;20:538 (Abstract T-26) 2006 results in: https://www.ncbi.nlm.nih.gov/pubmed/16966688 (added 14/02/2019)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. At least 18 years of age, both males and females
- •2. Histologically confirmed diagnosis of melanoma
- •3. Progressive disease that is not surgically resectable, or metastatic Stage IV disease
- •4. Low LDH (defined as LDH less than or equal to 0.8 x ULN)
- •5. Chemotherapy naïve
- •6. Measurable disease
- •7. Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 1
- •8. At least 4 weeks and recovery from effects of major prior surgery or other therapy, including immunotherapy, radiation therapy, or cytokine, biologic or vaccine therapy
- •9. Adequate organ function
排除标准
- •1. Prior cytotoxic chemotherapy, including regional perfusion, or prior Genasense® treatment
- •2. Primary ocular or mucosal melanoma
- •3. Bone-only metastatic disease
- •4. History or presence of brain metastasis or leptomeningeal disease
- •5. Significant medical disease other than cancer
- •6. Organ allograft
研究者
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