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

Phase 1

Completed

• Conditions: Recurrent or Refractory T/NK-cell Malignancies
• Interventions: Drug: forodesine hydrochloride

• Registration Number: NCT00823355
• Lead Sponsor: Mundipharma K.K.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-01-08
• Study First Submitted QC: 2009-01-13
• Study First Posted: 2009-01-15
• Primary Completion: 2013-08
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-20
• Last Update Posted: 2013-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BCX1777	forodesine hydrochloride	-

Primary Outcome Measures

Name	Time	Method
To evaluate pharmacokinetics (PK) of oral BCX1777	March 2010
To evaluate the safety profile and tolerability of oral BCX1777 in patients with recurrent or refractory T/ NK-cell malignancies.	March 2010

Secondary Outcome Measures

Name	Time	Method
To correlate the plasma level of BCX1777 with plasma 2'-deoxyguanosine (dGuo)	March 2010
To analyze cell surface marker in peripheral blood mononuclear cell	March 2010
To evaluate pharmacodynamics (PD) of oral BCX1777	March 2010
To evaluate the efficacy of oral BCX1777	March 2010

Trial Locations

Locations (1)

Investigational Site; 🇯🇵 Nagasaki, Japan