NIPH Clinical Trials Search

Basic Information

Recruitment status
Health condition(s) or Problem(s) studied	Recurrent or refractory T/NK-cell malignancies
Date of first enrollment	08/01/2009
Target sample size	24
Countries of recruitment
Study type	Interventional
Intervention(s)	investigational material(s) Generic name etc : BCX1777 INN of investigational material : Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : Oral

Outcome(s)

Primary Outcome	Safety assessment Safety assessment will be performed by NCI-CTCAE (Ver. 3.0).
Secondary Outcome	Bioanalytical Methods The plasma concentrations of BCX1777 is analyzed by LC-MS/MS.

Key inclusion & exclusion criteria

Age minimum	>= 20age old
Age maximum	Not applicable
Gender	Both
Include criteria	Inclusion Criteria (excerpted) - 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-cekk malignancies who has received at lease one chemotherapeutic regimen
Exclude criteria	Exclusion criteria (excerpted) - Pregnant, breast-feeding female, female with a possibility of becoming pregnant ("fertile female"; in the case of female before menopause or within a year from menopause, the patient sho is positive in the pregnancy test conducted within 14 days before the start of administration), or male and fertile female unwilling to practice appropriate contraception during the 2 mounths after the final administration. - Active serious infection not controlled by oral or intravenous antibiotics.