- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00823355
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
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
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Nagasaki, Japan
- Investigational Site
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Aichi
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Nagoya, Aichi, Japan
- Investigational Site
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Tokyo
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Cyuo, Tokyo, Japan
- Investigational Site
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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:
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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 |
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EXPERIMENTAL: BCX1777
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Cohort 1: 100mg / body (1 x 100mg tablet once daily)
Cohort 2: 200mg / body (2 x 100mg tablets once daily)
Cohort 3: 300mg / body (3 x 100mg tablets once daily)
Cohort 4: 400mg / body (4 x 100mg tablets once daily)
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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
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March 2010
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To evaluate pharmacokinetics (PK) of oral BCX1777
Time Frame: March 2010
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March 2010
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To evaluate pharmacodynamics (PD) of oral BCX1777
Time Frame: March 2010
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March 2010
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To correlate the plasma level of BCX1777 with plasma 2'-deoxyguanosine (dGuo)
Time Frame: March 2010
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March 2010
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To evaluate the efficacy of oral BCX1777
Time Frame: March 2010
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March 2010
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To analyze cell surface marker in peripheral blood mononuclear cell
Time Frame: March 2010
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March 2010
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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.
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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