EUCTR2009-013691-47-FR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
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
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 = 1.
- •- Adequate haematological, renal and hepatic 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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Allogeneic bone marrow transplant.
- •- Major surgery within previous 4 weeks.
- •- Concurrent therapeutic anticoagulation by AVK (Phase I part only).
- •- Corticosteroids > 20 mg prednisone equivalent per day.
- •- Immunotherapy, chemotherapy (nitrosoureas within 6 weeks) or radiotherapy within previous 4 weeks.
- •- Patients treated by valproic acid.
- •- Any other previous (in the last 5 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
相似试验
进行中（未招募）
1 期
Phase I/II dose-escalation study of S 78454 in LymphomaHodgkin's disease (HD) , non-Hodgkin lymphoma (NHL) and chronic lymphocytic Leukaemia (CLL)MedDRA version: 18.0 Level: PT Classification code 10029547 Term: Non-Hodgkin's lymphoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 18.0 Level: PT Classification code 10020206 Term: Hodgkin's disease System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 18.0 Level: LLT Classification code 10008993 Term: Chronic lymphoid leukaemia System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2009-013691-47-GBPharmacyclics LLC135
进行中（未招募）
1 期
Phase I/II dose-escalation study of S 78454 in LymphomaEUCTR2009-013691-47-HUPharmacyclics LLC156
进行中（未招募）
1 期
Phase I/II dose-escalation study of S 78454 in LymphomaEUCTR2009-013691-47-BEPharmacyclics. LLC156
终止
1 期
Phase I dose-escalation study of oral administration of S055746 in patients with Acute Myeloid Leukaemia or Myelodysplastic SyndromeCancerISRCTN73586707Institut de Recherches Internationales Servier (France)80
已完成
1 期
Phase I study of oral administration of S 78454 in association with doxorubicin in patients with solid tumourSolid tumoursMalignant neoplasm, unspecifiedCancerISRCTN55052510Institut de Recherches Internationales Servier (France)36