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

September 20, 2013 updated by: Mundipharma K.K.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Nagasaki, Japan
        • Investigational Site
    • Aichi
      • Nagoya, Aichi, Japan
        • Investigational Site
    • Tokyo
      • Cyuo, Tokyo, Japan
        • Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: BCX1777
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)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mundipharma K.K.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (ACTUAL)

August 1, 2013

Study Registration Dates

First Submitted

January 8, 2009

First Submitted That Met QC Criteria

January 13, 2009

First Posted (ESTIMATE)

January 15, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

September 23, 2013

Last Update Submitted That Met QC Criteria

September 20, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BCX1777-J01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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