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

Primary Purpose

Recurrent or Refractory T/NK-cell Malignancies

Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
forodesine hydrochloride
forodesine hydrochloride
forodesine hydrochloride
forodesine hydrochloride
Sponsored by
Mundipharma K.K.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent or Refractory T/NK-cell Malignancies

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

-

Sites / Locations

  • Investigational Site
  • Investigational Site
  • Investigational Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BCX1777

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
January 8, 2009
Last Updated
September 20, 2013
Sponsor
Mundipharma K.K.
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1. Study Identification

Unique Protocol Identification Number
NCT00823355
Brief Title
Oral Forodesine Hydrochloride (BCX-1777) in Patients With Recurrent or Refractory T/NK-cell Malignancies
Official Title
A Phase I, Open Label, Dose Ascending Study of BCX1777 (Oral) in Patients With Recurrent or Refractory T/NK-cell Malignancies
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mundipharma K.K.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent or Refractory T/NK-cell Malignancies

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
BCX1777
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
forodesine hydrochloride
Intervention Description
Cohort 1: 100mg / body (1 x 100mg tablet once daily)
Intervention Type
Drug
Intervention Name(s)
forodesine hydrochloride
Intervention Description
Cohort 2: 200mg / body (2 x 100mg tablets once daily)
Intervention Type
Drug
Intervention Name(s)
forodesine hydrochloride
Intervention Description
Cohort 3: 300mg / body (3 x 100mg tablets once daily)
Intervention Type
Drug
Intervention Name(s)
forodesine hydrochloride
Intervention Description
Cohort 4: 400mg / body (4 x 100mg tablets once daily)
Primary Outcome Measure Information:
Title
To evaluate the safety profile and tolerability of oral BCX1777 in patients with recurrent or refractory T/ NK-cell malignancies.
Time Frame
March 2010
Title
To evaluate pharmacokinetics (PK) of oral BCX1777
Time Frame
March 2010
Secondary Outcome Measure Information:
Title
To evaluate pharmacodynamics (PD) of oral BCX1777
Time Frame
March 2010
Title
To correlate the plasma level of BCX1777 with plasma 2'-deoxyguanosine (dGuo)
Time Frame
March 2010
Title
To evaluate the efficacy of oral BCX1777
Time Frame
March 2010
Title
To analyze cell surface marker in peripheral blood mononuclear cell
Time Frame
March 2010

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: -
Facility Information:
Facility Name
Investigational Site
City
Nagoya
State/Province
Aichi
Country
Japan
Facility Name
Investigational Site
City
Cyuo
State/Province
Tokyo
Country
Japan
Facility Name
Investigational Site
City
Nagasaki
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
22448814
Citation
Ogura M, Tsukasaki K, Nagai H, Uchida T, Oyama T, Suzuki T, Taguchi J, Maruyama D, Hotta T, Tobinai K. Phase I study of BCX1777 (forodesine) in patients with relapsed or refractory peripheral T/natural killer-cell malignancies. Cancer Sci. 2012 Jul;103(7):1290-5. doi: 10.1111/j.1349-7006.2012.02287.x. Epub 2012 Apr 30.
Results Reference
derived

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

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