MedTrace Logo

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

NCT00823355 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2013-09-23

No results posted yet for this study

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

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)

Sponsors & Collaborators

  • Mundipharma K.K.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2013-08-31

Countries

  • Japan

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00823355 on ClinicalTrials.gov