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

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ClinicalTrials.gov Identifier: NCT00823355
Recruitment Status : Completed
First Posted : January 15, 2009
Last Update Posted : September 23, 2013
Sponsor:
Information provided by (Responsible Party):
Mundipharma K.K.

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.

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : January 2009
Actual Primary Completion Date : August 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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)



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

Secondary Outcome Measures :
  1. To evaluate pharmacodynamics (PD) of oral BCX1777 [ Time Frame: March 2010 ]
  2. To correlate the plasma level of BCX1777 with plasma 2'-deoxyguanosine (dGuo) [ Time Frame: March 2010 ]
  3. To evaluate the efficacy of oral BCX1777 [ Time Frame: March 2010 ]
  4. To analyze cell surface marker in peripheral blood mononuclear cell [ Time Frame: March 2010 ]


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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00823355


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

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
First Posted: January 15, 2009    Key Record Dates
Last Update Posted: September 23, 2013
Last Verified: September 2013

Additional relevant MeSH terms:
Neoplasms