Clinical trial · Interventional
Oral Forodesine Hydrochloride (BCX-1777) in Patients With Recurrent or Refractory T/NK-cell Malignancies
A Phase I, Open Label, Dose Ascending Study of BCX1777 (Oral) in Patients With Recurrent or Refractory T/NK-cell Malignancies
NCT00823355CI-TRIAL-00012266completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent or Refractory T/NK-cell Malignancies | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| forodesine hydrochloride | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- BCX1777
- interventionNames
- Drug: forodesine hydrochloride
Primary outcomes (2)
- 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 (4)
- measure
- To evaluate pharmacodynamics (PD) of oral BCX1777
- timeFrame
- March 2010
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
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:
\-References
Publications (1)
- DERIVEDOgura 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. PMID 22448814