Phase I dose-escalation study of oral administration of the Pan-Histone Deacetylase (HDAC) inhibitor S 78454 in combination with standard hypofractionated radiotherapy in patients with advanced solid tumour

Pharmacyclics LLC (USA)0 个研究点目标入组 90 人开始时间: 2013年8月30日最近更新: 2019年3月18日

适应症

试验速览

•1. Solid tumour, with measurable or evaluable disease, requiring a course of hypofractionated radiotherapy
•2. Ability to swallow oral capsule(s) without difficulty
•3. Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
•4. Estimated life expectancy of more than 20 weeks
•5. Adequate haematological, renal and hepatic functions

•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. Previous radiotherapy on the same area
•5. Cumulative radiation therapy involving more than 25% of the total bone marrow
•6. 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
•7. Concurrent therapeutic anticoagulation by Vitamin K antagonists
•8. Patients treated by valproic acid
•9. Risk factors for, or use of medications known to prolong QTc interval and that may be associated with Torsades de Pointes.

发起方

Pharmacyclics LLC (USA)