Oral Forodesine Hydrochloride (BCX-1777) in Patients With Recurrent or Refractory T/NK-cell Malignancies

Recurrent or Refractory T/NK-cell Malignancies Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00823355
• Other study ID #: BCX1777-J01
• Status: Completed
• Phase: Phase 1
• First received: January 8, 2009
• Last updated: September 20, 2013
• Start date: January 2009

Study information

• Verified date: September 2013
• Source: Mundipharma K.K.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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:

Study Design

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• forodesine hydrochloride
Cohort 1: 100mg / body (1 x 100mg tablet once daily)
• forodesine hydrochloride
Cohort 2: 200mg / body (2 x 100mg tablets once daily)
• forodesine hydrochloride
Cohort 3: 300mg / body (3 x 100mg tablets once daily)
• forodesine hydrochloride
Cohort 4: 400mg / body (4 x 100mg tablets once daily)

Locations

Country	Name	City	State
Japan	Investigational Site	Cyuo	Tokyo
Japan	Investigational Site	Nagasaki
Japan	Investigational Site	Nagoya	Aichi

Sponsors (1)

Lead Sponsor	Collaborator
Mundipharma K.K.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the safety profile and tolerability of oral BCX1777 in patients with recurrent or refractory T/ NK-cell malignancies.		March 2010	Yes
Primary	To evaluate pharmacokinetics (PK) of oral BCX1777		March 2010	No
Secondary	To evaluate pharmacodynamics (PD) of oral BCX1777		March 2010	No
Secondary	To correlate the plasma level of BCX1777 with plasma 2'-deoxyguanosine (dGuo)		March 2010	No
Secondary	To evaluate the efficacy of oral BCX1777		March 2010	No
Secondary	To analyze cell surface marker in peripheral blood mononuclear cell		March 2010	No