A Phase II Clinical Trial of PXD101 in Patients With Recurrent or Refractory Cutaneous and Peripheral T-Cell Lymphomas

Phase 2 Terminated 53 enrolled Valerio Therapeutics

Non-randomizedParallel-groupOpen-labelTreatment

Summary

Open-label, non-randomized trial to assess the effectiveness of PXD101 in patients with recurrent or refractory cutaneous or peripheral and other types of T-cell lymphomas. PXD101 is a new, potent histone deacetylase (HDAC) inhibitor. Patients are treated with belinostat(PXD101) 1000 mg/m2 on days 1-5 of a 21 day cycle.

Timeline

Start: 2006-01
Primary completion: 2009-07
Completion: 2009-07

Outcome

Outcome not reported

Stopped (Enrollment): “Enrollment stopped prior to reaching expected number of patients, study had accumulated sufficient data to allow a registration study in PTCL (PXD101-CLN-19)”

Publications

Foss F, Advani R, Duvic M, Hymes KB, Intragumtornchai T, Lekhakula A, Shpilberg O, Lerner A, Belt RJ, Jacobsen ED, Laurent G, Ben-Yehuda D, Beylot-Barry M, Hillen U, Knoblauch P, Bhat G, Chawla S, Allen LF, Pohlman B. A Phase II trial of Belinostat (PXD101) in patients with relapsed or refractory peripheral or cutaneous T-cell lymphoma. Br J Haematol. 2015 Mar;168(6):811-9. doi: 10.1111/bjh.13222. Epub 2014 Nov 17.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Belinostat	Small molecule	1000 mg/m2	Intravenous