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A Phase I, Open Label, Dose Ascending Study of BCX1777 (Oral) in Patients With Recurrent or Refractory T/NK-cell Malignancies


Phase 1
20 Years
N/A
Open (Enrolling)
Both
Recurrent or Refractory T/NK-cell Malignancies

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Trial Information

A Phase I, Open Label, Dose Ascending Study of BCX1777 (Oral) in Patients With Recurrent or Refractory T/NK-cell Malignancies


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:

-

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate the safety profile and tolerability of oral BCX1777 in patients with recurrent or refractory T/ NK-cell malignancies.

Outcome Time Frame:

March 2010

Safety Issue:

Yes

Authority:

Japan: Ministry of Health, Labor and Welfare

Study ID:

BCX1777-J01

NCT ID:

NCT00823355

Start Date:

January 2009

Completion Date:

December 2016

Related Keywords:

  • Recurrent or Refractory T/NK-cell Malignancies
  • Neoplasms

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