Oral Forodesine Hydrochloride (BCX-1777) in Patients With Recurrent or Refractory T/NK-cell Malignancies

Mundipharma

Status and phase

Completed

Phase 1

Conditions

Recurrent or Refractory T/NK-cell Malignancies

Treatments

Drug: forodesine hydrochloride

Study type

Interventional

Funder types

Industry

Identifiers

NCT00823355

BCX1777-J01

Details and patient eligibility

About

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.

Enrollment

24 estimated patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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.