A Phase I, Open Label, Dose Ascending Study of BCX1777 (Oral) in Patients With Recurrent or Refractory T/NK-cell Malignancies
Sponsor study identifier
interventional
24
1 country
3
Study Start
January 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2013
Actual (reported)Study Completion
Not reported
Date not reportedPrimary 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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2009
Date type not reportedThis date has not been verified as actual or estimated.
January 8, 2009
Actual (reported)January 15, 2009
Actual (reported)August 2013
Actual (reported)To evaluate the safety profile and tolerability of oral BCX1777 in patients with recurrent or refractory T/ NK-cell malignancies.
March 2010
To evaluate pharmacokinetics (PK) of oral BCX1777
March 2010
To evaluate pharmacodynamics (PD) of oral BCX1777
March 2010
To correlate the plasma level of BCX1777 with plasma 2'-deoxyguanosine (dGuo)
March 2010
To evaluate the efficacy of oral BCX1777
March 2010
To analyze cell surface marker in peripheral blood mononuclear cell
March 2010
Cohort 1: 100mg / body (1 x 100mg tablet once daily)
Cohort 2: 200mg / body (2 x 100mg tablets once daily)
Investigational Site
Nagoya, Aichi-ken, Japan
Investigational Site
Nagasaki, Nagasaki, Japan
Investigational Site
Cyuo, Tokyo, Japan
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.
First Submitted
January 8, 2009
First Posted
January 15, 2009
Study Start
January 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2013
Actual (reported)BCX-1777 in Treating Patients With Refractory Cutaneous T-Cell Lymphoma
Cohort 3: 300mg / body (3 x 100mg tablets once daily)
Cohort 4: 400mg / body (4 x 100mg tablets once daily)
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Last Updated
September 23, 2013
Record last verified: 2013-09
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Source: ClinicalTrials.gov.
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