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

Pharmacyclics LLC0 个研究点目标入组 135 人开始时间: 2012年1月10日最近更新: 2019年2月28日

适应症

试验速览

暂无简介。

•- 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 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 71
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 85

•- 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.

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