Phase 1 Dose Finding Study of Belinostat for Treatment of Patients With Peripheral T-cell Lymphoma (PTCL)

Phase 1 Completed 23 enrolled Acrotech Biopharma Inc.

NaSingle-groupOpen-labelTreatment

Summary

The primary objective of this study is to determine the Maximum Tolerated Dose (MTD) for belinostat when combined with CHOP regimen and establish the recommended belinostat dose for the Phase 3 study.

Timeline

Start: 2013-05
Primary completion: 2016-01
Completion: 2016-01

Publications

Johnston PB, Cashen AF, Nikolinakos PG, Beaven AW, Barta SK, Bhat G, Hasal SJ, De Vos S, Oki Y, Deng C, Foss FM. Belinostat in combination with standard cyclophosphamide, doxorubicin, vincristine and prednisone as first-line treatment for patients with newly diagnosed peripheral T-cell lymphoma. Exp Hematol Oncol. 2021 Feb 18;10(1):15. doi: 10.1186/s40164-021-00203-8.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Belinostat	Small molecule	1000 mg/m2	Intravenous
Background	Cyclophosphamide	Other / unclassified	750 mg/m2	Intravenous
Background	Doxorubicin	Other / unclassified	50 mg/m2	Intravenous
Background	Prednisone	Other / unclassified	100 mg	Oral
Background	Vincristine	Small molecule	1.4 mg/m2	Intravenous

Phase 1 Dose Finding Study of Belinostat for Treatment of Patients With Peripheral T-cell Lymphoma (PTCL)

Summary

Timeline

Publications

Drugs

Indications