Oral Forodesine Hydrochloride (BCX-1777) in Patients With Recurrent or Refractory T/NK-cell Malignancies
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: BCX1777
|
Drug: forodesine hydrochloride
Cohort 1: 100mg / body (1 x 100mg tablet once daily)
Drug: forodesine hydrochloride
Cohort 2: 200mg / body (2 x 100mg tablets once daily)
Drug: forodesine hydrochloride
Cohort 3: 300mg / body (3 x 100mg tablets once daily)
Drug: forodesine hydrochloride
Cohort 4: 400mg / body (4 x 100mg tablets once daily)
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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]
Eligibility Criteria
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
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Eastern Cooperative Oncology Group(ECOG) performance status:0,1.
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Able to be hospitalized at least for 15 days from the first dose
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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
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Platelet count: ≥75,000/mm3
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In the case of CTCL, the tumor cell rate is handled as ≤25%.
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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:
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Investigational Site | Nagoya | Aichi | Japan | |
| 2 | Investigational Site | Cyuo | Tokyo | Japan | |
| 3 | Investigational Site | Nagasaki | Japan |
Sponsors and Collaborators
- Mundipharma K.K.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BCX1777-J01