Phase I Clinical Trial to Assess the Safety and PK Profile of CKD-581 in Patients With Lymphoma Failed to Standard Therapy
Recently, the role of transcriptional repression through epigenetic modulation in
carcinogenesis has been clinically validated with several inhibitors of histone deacetylases
and DNA methyltransferases. It has long been recognized that epigenetic alterations of tumor
suppressor genes was one of the contributing factors in carcinogenesis. Inhibitors of
histone deacetylase (HDAC) de-repress genes that subsequently result in growth inhibition,
differentiation and apoptosis of cancer cells. CKD-581 is developed for HDAC inhibitors.
Such as to determine the maximum tolerated dose (MTD), dose limiting toxicity (DLT), safety
and pharmacokinetics (PK) profile of a single agent CKD-581 injection in patients with
Lymphoma failed to standard therapy.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
•MTD, Maximum Tolerated Dose
MTD: up to 28 days (1st cycle)
Korea: Food and Drug Administration