Status:
COMPLETED
Oral Forodesine Hydrochloride (BCX-1777) in Patients With Recurrent or Refractory T/NK-cell Malignancies
Lead Sponsor:
Mundipharma K.K.
Conditions:
Recurrent or Refractory T/NK-cell Malignancies
Eligibility:
All Genders
20+ years
Phase:
PHASE1
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 (...
Eligibility Criteria
Inclusion
- 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
- \-
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00823355
Start Date
January 1 2009
Last Update
September 23 2013
Active Locations (3)
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1
Investigational Site
Nagoya, Aichi-ken, Japan
2
Investigational Site
Nagasaki, Nagasaki, Japan
3
Investigational Site
Cyuo, Tokyo, Japan