Primary objectives are to evaluate the safety profile and tolerability of oral BCX1777 in each cohort of patients with recurrent or refractory T/NK-cell malignancies and to evaluate pharmacokinetics (PK) of oral BCX1777.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Cohort 1: 100mg / body (1 x 100mg tablet once daily)
Cohort 2: 200mg / body (2 x 100mg tablets once daily)
Cohort 3: 300mg / body (3 x 100mg tablets once daily)
Investigational Site
Nagoya, Aichi-ken, Japan
Investigational Site
Nagasaki, Nagasaki, Japan
Investigational Site
Cyuo, Tokyo, Japan
To evaluate the safety profile and tolerability of oral BCX1777 in patients with recurrent or refractory T/ NK-cell malignancies.
Time frame: March 2010
To evaluate pharmacokinetics (PK) of oral BCX1777
Time frame: March 2010
To evaluate pharmacodynamics (PD) of oral BCX1777
Time frame: March 2010
To correlate the plasma level of BCX1777 with plasma 2'-deoxyguanosine (dGuo)
Time frame: March 2010
To evaluate the efficacy of oral BCX1777
Time frame: March 2010
To analyze cell surface marker in peripheral blood mononuclear cell
Time frame: March 2010
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Cohort 4: 400mg / body (4 x 100mg tablets once daily)