drugset

drugset / Trial / NCT01537744

A Trial of Oral 5-azacitidine in Combination With Romidepsin in Advanced Solid Tumors, With an Expansion Cohort in Virally Mediated Cancers and Liposarcoma

NCT01537744 ↗

Phase 1 Completed 18 enrolled Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Celgene Corporation · collab

NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to determine whether 5-azacitidine in combination with romidepsin cancer are effective in the treatment of advanced solid tumors.

Timeline

Start: 2012-02
Primary completion: 2016-03
Completion: 2016-09

Publications

Gaillard SL, Zahurak M, Sharma A, Durham JN, Reiss KA, Sartorius-Mergenthaler S, Downs M, Anders NM, Ahuja N, Rudek MA, Azad N. A phase 1 trial of the oral DNA methyltransferase inhibitor CC-486 and the histone deacetylase inhibitor romidepsin in advanced solid tumors. Cancer. 2019 Aug 15;125(16):2837-2845. doi: 10.1002/cncr.32138. Epub 2019 Apr 23.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Azacitidine	Other / unclassified	100 mg	Oral
Subject	Azacitidine	Other / unclassified	200 mg	Oral
Subject	Azacitidine	Other / unclassified	300 mg	Oral
Subject	Romidepsin	Peptide	8 mg/m2	Intravenous

Indications