A Phase I/II Study of Azacitidine, Docetaxel, and Prednisone for Metastatic Prostate Cancer Patients

Phase 1/2 Terminated 22 enrolled University of Miami

Non-randomizedSingle-groupOpen-labelTreatment

Summary

Azacitidine can reverse clinical resistance to docetaxel through upregulation of Growth Arrest and DNA Damage inducible alpha (GADD45α) and other epigenetically regulated genes.

Timeline

Start: 2007-05
Primary completion: 2015-06
Completion: 2015-06

Outcome

Outcome not reported

Stopped (Business): “Withdrawal of Funding”

Publications

Background Singal R, Ramachandran K, Gordian E, Quintero C, Zhao W, Reis IM. Phase I/II study of azacitidine, docetaxel, and prednisone in patients with metastatic castration-resistant prostate cancer previously treated with docetaxel-based therapy. Clin Genitourin Cancer. 2015 Feb;13(1):22-31. doi: 10.1016/j.clgc.2014.07.008. Epub 2014 Aug 1.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Azacitidine	Other / unclassified	—	Intravenous
Subject	Docetaxel	Small molecule	—	Intravenous
Subject	Prednisone	Other / unclassified	5 mg	—
Background	Pegfilgrastim	Protein / enzyme biologic	—	—
Background	filgrastim	Protein / enzyme biologic	—	—