Clinical Trial: Oral Forodesine Hydrochloride (BCX-1777) in Patients With Recurrent or Refractory T/NK-cell Malignancies
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Phase I, Open Label, Dose Ascending Study of BCX1777 (Oral) in Patients With Recurrent or Refractory T/NK-cell Malignancies
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.
Detailed Summary:
Sponsor: Mundipharma K.K.
Current Primary Outcome:
- To evaluate the safety profile and tolerability of oral BCX1777 in patients with recurrent or refractory T/ NK-cell malignancies. [ Time Frame: March 2010 ]
- To evaluate pharmacokinetics (PK) of oral BCX1777 [ Time Frame: March 2010 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- To evaluate pharmacodynamics (PD) of oral BCX1777 [ Time Frame: March 2010 ]
- To correlate the plasma level of BCX1777 with plasma 2'-deoxyguanosine (dGuo) [ Time Frame: March 2010 ]
- To evaluate the efficacy of oral BCX1777 [ Time Frame: March 2010 ]
- To analyze cell surface marker in peripheral blood mononuclear cell [ Time Frame: March 2010 ]
Original Secondary Outcome: Same as current
Information By: Mundipharma K.K.
Dates:
Date Received: January 8, 2009
Date Started: January 2009
Date Completion:
Last Updated: September 20, 2013
Last Verified: September 2013
