NCT00823355

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Mundipharma K.K. · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Recurrent or Refractory T/NK-cell Malignancies

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2009-01-01
• Primary completion: 2013-08-01
• First posted: 2009-01-15
• Last updated: 2013-09-23

Locations

3 sites across 1 country: Japan