Clinical trial NCT00823355: Oral Forodesine Hydrochloride (BCX-1777) in Patients With Recurrent or Refractory T/NK-cell Malignancies
Official title: A Phase I, Open Label, Dose Ascending Study of BCX1777 (Oral) in Patients With Recurrent or Refractory T/NK-cell Malignancies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Recurrent or Refractory T/NK-cell Malignancies
Lead sponsor: Mundipharma K.K.
Sponsor class: INDUSTRY
First posted: 2009-01-15
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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:

-

Primary outcomes:
measure: To evaluate the safety profile and tolerability of oral BCX1777 in patients with recurrent or refractory T/ NK-cell malignancies.
timeFrame: March 2010
measure: To evaluate pharmacokinetics (PK) of oral BCX1777
timeFrame: March 2010
Secondary outcomes:
measure: To evaluate pharmacodynamics (PD) of oral BCX1777
timeFrame: March 2010
measure: To correlate the plasma level of BCX1777 with plasma 2'-deoxyguanosine (dGuo)
timeFrame: March 2010
measure: To evaluate the efficacy of oral BCX1777
timeFrame: March 2010
measure: To analyze cell surface marker in peripheral blood mononuclear cell
timeFrame: March 2010
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Investigational Site
state: Aichi
city: Cyuo
country: Japan
facility: Investigational Site
state: Tokyo
city: Nagasaki
country: Japan
facility: Investigational Site
Study officials:
References:
citation: Ogura M, Tsukasaki K, Nagai H, Uchida T, Oyama T, Suzuki T, Taguchi J, Maruyama D, Hotta T, Tobinai K. Phase I study of BCX1777 (forodesine) in patients with relapsed or refractory peripheral T/natural killer-cell malignancies. Cancer Sci. 2012 Jul;103(7):1290-5. doi: 10.1111/j.1349-7006.2012.02287.x. Epub 2012 Apr 30.