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
1 other identifier
interventional
24
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2009
CompletedFirst Submitted
Initial submission to the registry
January 8, 2009
CompletedFirst Posted
Study publicly available on registry
January 15, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2013
CompletedSeptember 23, 2013
September 1, 2013
4.6 years
January 8, 2009
September 20, 2013
Conditions
Outcome Measures
Primary Outcomes (2)
To evaluate the safety profile and tolerability of oral BCX1777 in patients with recurrent or refractory T/ NK-cell malignancies.
March 2010
To evaluate pharmacokinetics (PK) of oral BCX1777
March 2010
Secondary Outcomes (4)
To evaluate pharmacodynamics (PD) of oral BCX1777
March 2010
To correlate the plasma level of BCX1777 with plasma 2'-deoxyguanosine (dGuo)
March 2010
To evaluate the efficacy of oral BCX1777
March 2010
To analyze cell surface marker in peripheral blood mononuclear cell
March 2010
Study Arms (1)
BCX1777
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mundipharma K.K.lead
Study Sites (3)
Investigational Site
Nagoya, Aichi-ken, Japan
Investigational Site
Nagasaki, Nagasaki, Japan
Investigational Site
Cyuo, Tokyo, Japan
Related Publications (1)
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.
PMID: 22448814DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 8, 2009
First Posted
January 15, 2009
Study Start
January 1, 2009
Primary Completion
August 1, 2013
Last Updated
September 23, 2013
Record last verified: 2013-09