ISRCTN96863717已完成1 期
Phase I dose-escalation study of oral administration of Pan-Histone Deacetylase (HDAC) Inhibitor S 78454 in patients with solid tumour
Institut de Recherches Internationales Servier (France)0 个研究点目标入组 60 人开始时间: 2013年8月6日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
研究概览
简要总结
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23790467
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Male or female patient aged > or equal to 18
- •2. Solid tumour with measurable or evaluable disease, that has relapsed or is refractory to conventional standard forms of therapy
- •3. Ability to swallow oral capsule(s) without difficulty
- •4. Estimated life expectancy > 12 weeks
- •5. Eastern Cooperative Oncology Group (ECOG) performance status less or equal to 1
- •6. Adequate haematological, renal and hepatic functions
排除标准
- •1. Allogenic bone marrow transplant
- •2. Major surgery within previous 4 weeks
- •3. Chemotherapy within previous 3 weeks (6 weeks in case of nitrosoureas)
- •4. Radiotherapy within previous 4 weeks (except for palliative radiotherapy at localised lesions)
- •5. Immunotherapy or hormonotherapy within previous 2 weeks, except stable luteinizing hormone-releasing hormone (LHRH) agonist therapy for prostate cancer, stable oral glucocorticoid and mineralocorticoid replacement for adrenal insufficiency, stable mitotane for adrenal carcinoma, or oral contraceptives
- •6. Concurrent therapeutic anticoagulation by anti-vitamin K (AVK)
- •7. Patients treated by valproic acid
- •8. Any other previous (in the last 3 years) or concurrent cancer, other than resected non-melanoma skin cancer or cancer in situ of the uterine cervix
- •9. Risk factors for, or use of drugs known to prolong QTc interval and that may be associated with Torsades de Pointes
研究者
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