A Phase I, Open Label, Dose Ascending Study of BCX1777 (Oral) in Patients With Recurrent or Refractory T/NK-cell Malignancies
- Histologically documented with histopathological diagnosis from biopsy, T/NK-cell
malignancies (WHO classification). Precursor T-cell lymphoblastic leukemia/lymphoma
(T-ALL/T-LBL) should be excluded in this study
- A patient with recurrent, relapse or refractory T/NK-cell malignancies who has
received at lease one chemotherapeutic regimen
- Age 20 or greater
- Eastern Cooperative Oncology Group(ECOG) performance status:0,1.
- Able to be hospitalized at least for 15 days from the first dose
- In the case of subject with tumor cell rate of ≤25% in bone marrow, a patient who
satisfies both of the following criteria.
- Neutrophil count: ≥1,200/mm3
- Platelet count: ≥75,000/mm3
- In the case of CTCL, the tumor cell rate is handled as ≤25%.
- Adequate Liver function: AST, ALT ≤ 5.0 x upper limit of normal (ULN)
- Adequate Renal function: Creatinine Clearance (using cockcroft-Gault formula) ≥
- Life expectancy of at least 3 months
- A patient who has given a written informed consent prior to the start of procedures
proper to this study.