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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BCX1777 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| forodesine hydrochloride | Drug | Cohort 1: 100mg / body (1 x 100mg tablet once daily) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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
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:
-
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site | Nagoya | Aichi-ken | Japan | |||
| Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22448814 | Derived | 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. |
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| forodesine hydrochloride |
| Drug |
Cohort 2: 200mg / body (2 x 100mg tablets once daily) |
|
| forodesine hydrochloride | Drug | Cohort 3: 300mg / body (3 x 100mg tablets once daily) |
|
| forodesine hydrochloride | Drug | Cohort 4: 400mg / body (4 x 100mg tablets once daily) |
|
| March 2010 |
| To analyze cell surface marker in peripheral blood mononuclear cell | March 2010 |
| Nagasaki |
| Nagasaki |
| Japan |
| Investigational Site | Cyuo | Tokyo | Japan |
| ID | Term |
|---|---|
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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