An Investigational Study of a Histone Deacetylase (HDAC) Inhibitor Plus Targretin in Cutaneous T-Cell Lymphoma Patients (0683-016)(TERMINATED)

Phase 1 Terminated 23 enrolled Merck Sharp & Dohme LLC

Non-randomizedSingle-groupOpen-labelTreatment

Summary

This is an investigational study that increases the dosage to determine the safety/tolerability, and efficacy of a histone deacetylase inhibitor in combination with Targretin in patients with cutaneous T-cell lymphoma in patients who have failed at least one prior systemic therapy.

Timeline

Start: 2005-09
Primary completion: 2008-10
Completion: 2008-10

Publications

Results Dummer R, Beyer M, Hymes K, Epping MT, Bernards R, Steinhoff M, Sterry W, Kerl H, Heath K, Ahern JD, Hardwick JS, Garcia-Vargas J, Baumann K, Rizvi S, Frankel SR, Whittaker SJ, Assaf C. Vorinostat combined with bexarotene for treatment of cutaneous T-cell lymphoma: in vitro and phase I clinical evidence supporting augmentation of retinoic acid receptor/retinoid X receptor activation by histone deacetylase inhibition. Leuk Lymphoma. 2012 Aug;53(8):1501-8. doi: 10.3109/10428194.2012.656625. Epub 2012 Feb 13.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bexarotene	Small molecule	150 mg/m2	Oral
Subject	Bexarotene	Small molecule	150 mg	Oral
Subject	Bexarotene	Small molecule	225 mg/m2	Oral
Subject	Bexarotene	Small molecule	225 mg	Oral
Subject	Bexarotene	Small molecule	300 mg/m2	Oral
Subject	Vorinostat	Small molecule	200 mg	Oral
Subject	Vorinostat	Small molecule	300 mg	Oral
Subject	Vorinostat	Small molecule	400 mg	Oral

An Investigational Study of a Histone Deacetylase (HDAC) Inhibitor Plus Targretin in Cutaneous T-Cell Lymphoma Patients (0683-016)(TERMINATED)

Summary

Timeline

Publications

Drugs

Indications