Recurrent or refractory T/NK-cell malignancies
Conditions
Interventions
investigational material(s)
Generic name etc : BCX1777
INN of investigational material :
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational material
Sponsors
Mundipharma K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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
Exclusion criteria
Exclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety assessment Safety assessment will be performed by NCI-CTCAE (Ver. 3.0). | — |
Secondary
| Measure | Time frame |
|---|---|
| Bioanalytical Methods The plasma concentrations of BCX1777 is analyzed by LC-MS/MS. | — |
Outcome results
None listed