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Completed

NCT Number: NCT00823355

Oral Forodesine Hydrochloride (BCX-1777) 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.

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Key information

Conditions

Recurrent or Refractory T/NK-cell Malignancies Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Investigational Site, Nagoya, Aichi-ken, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

forodesine hydrochloride

Drug

Cohort 1: 100mg / body (1 x 100mg tablet once daily)

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Mundipharma K.K.

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2013
First posted
Jan 15, 2009
Registry last updated
Sep 23, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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