EUCTR2009-013691-47-HU进行中（未招募）1 期
Phase I/II dose-escalation study of oral administration of the Pan-Histone Deacetylase (HDAC) Inhibitor S 78454 in Hodgkin’s Disease, non-Hodgkin Lymphoma and Chronic Lymphocytic Leukaemia
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 156
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
- •- HD or NHL that has relapsed or is refractory to conventional, standard form of therapy.
- •- CLL that has relapsed or is refractory to conventional, standard form of therapy.
- •- Ability to swallow oral capsule(s) without difficulty.
- •- Estimated life expectancy > 12 weeks.
- •- ECOG performance status = 2.
- •- Adequate haematological, renal, hepatic and cardiac functions.
- •Are the trial subjects under 18? no
- •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 71
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 85
排除标准
- •- Allogeneic bone marrow transplant.
- •- Major surgery within previous 4 weeks.
- •- Concurrent therapeutic anticoagulation by AVK.
- •- Patient previously treated by another HDAC Inhibitor than valproic acid (Phase II part).
- •- Corticosteroids > 20 mg prednisone equivalent per day within previous 10 days.
- •- Immunotherapy, chemotherapy (nitrosoureas within 6 weeks) or radiotherapy within previous 4 weeks.
- •- Patients treated by valproic acid within previous 5 days.
- •- 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.
- •- Risk factors for, or use of drugs known to prolong QTc interval or that may be associated with Torsades de Pointes.
研究者
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