Recurrent or Refractory T/NK-cell Malignancies
Conditions
Brief summary
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.
Interventions
Cohort 1: 100mg / body (1 x 100mg tablet once daily)
Sponsors
Mundipharma K.K.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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) ≥ 50mL/min * 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.
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the safety profile and tolerability of oral BCX1777 in patients with recurrent or refractory T/ NK-cell malignancies. | March 2010 |
| To evaluate pharmacokinetics (PK) of oral BCX1777 | March 2010 |
Secondary
| Measure | Time frame |
|---|---|
| To correlate the plasma level of BCX1777 with plasma 2'-deoxyguanosine (dGuo) | March 2010 |
| To evaluate pharmacodynamics (PD) of oral BCX1777 | March 2010 |
| To evaluate the efficacy of oral BCX1777 | March 2010 |
| To analyze cell surface marker in peripheral blood mononuclear cell | March 2010 |
Countries
Japan
Outcome results
None listed