Phase I, open label, dose ascending study of BCX1777 (oral) in patients with recurrent or refractory T/NK-cell malignancies
- Conditions
- Recurrent or refractory T/NK-cell malignancies
- Registration Number
- JPRN-jRCT2080220654
- Lead Sponsor
- Mundipharma K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 24
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 (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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety assessment<br>Safety assessment will be performed by NCI-CTCAE (Ver. 3.0).
- Secondary Outcome Measures
Name Time Method Bioanalytical Methods<br>The plasma concentrations of BCX1777 is analyzed by LC-MS/MS.