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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mundipharma K.K.
ClinicalTrials.gov Identifier:
NCT00823355
First received: January 8, 2009
Last updated: September 20, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Recurrent or Refractory T/NK-cell Malignancies
Drug: forodesine hydrochloride
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I, Open Label, Dose Ascending Study of BCX1777 (Oral) in Patients With Recurrent or Refractory T/NK-cell Malignancies

Resource links provided by NLM:


Further study details as provided by Mundipharma K.K.:

Primary Outcome Measures:
  • To evaluate the safety profile and tolerability of oral BCX1777 in patients with recurrent or refractory T/ NK-cell malignancies. [ Time Frame: March 2010 ] [ Designated as safety issue: Yes ]
  • To evaluate pharmacokinetics (PK) of oral BCX1777 [ Time Frame: March 2010 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate pharmacodynamics (PD) of oral BCX1777 [ Time Frame: March 2010 ] [ Designated as safety issue: No ]
  • To correlate the plasma level of BCX1777 with plasma 2'-deoxyguanosine (dGuo) [ Time Frame: March 2010 ] [ Designated as safety issue: No ]
  • To evaluate the efficacy of oral BCX1777 [ Time Frame: March 2010 ] [ Designated as safety issue: No ]
  • To analyze cell surface marker in peripheral blood mononuclear cell [ Time Frame: March 2010 ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: January 2009
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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:

-

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00823355

Locations
Japan
Investigational Site
Nagoya, Aichi, Japan
Investigational Site
Cyuo, Tokyo, Japan
Investigational Site
Nagasaki, Japan
Sponsors and Collaborators
Mundipharma K.K.
  More Information

No publications provided by Mundipharma K.K.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mundipharma K.K.
ClinicalTrials.gov Identifier: NCT00823355     History of Changes
Other Study ID Numbers: BCX1777-J01
Study First Received: January 8, 2009
Last Updated: September 20, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on April 21, 2014