XERECEPT® (hCRF) for Patients Requiring Dexamethasone to Treat Edema Associated With Brain Tumors

Phase 3 Completed 200 enrolled Celtic Pharma Development Services Neurobiological Technologies · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to compare the safety and efficacy of XERECEPT® to dexamethasone (Decadron) a common treatment for symptoms of brain swelling (edema). This study is specifically aimed at patients who require chronic high doses of dexamethasone to manage symptoms.

Timeline

Start: 2004-05
Primary completion: 2008-03
Completion: 2008-03

Outcome

Missed primary endpoint

paper Although results did not attain statistical significance (at the P < .05 level), a clinically important difference in the proportion of responders PMID 23382470 ↗

paper the proportion of responders between the CrA group (57.0%) and the placebo group (46.0%; P = .12) was observed. PMID 23382470 ↗

Publications

Recht L, Mechtler LL, Wong ET, O'Connor PC, Rodda BE. Steroid-sparing effect of corticorelin acetate in peritumoral cerebral edema is associated with improvement in steroid-induced myopathy. J Clin Oncol. 2013 Mar 20;31(9):1182-7. doi: 10.1200/JCO.2012.43.9455. Epub 2013 Feb 4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Xerecept	Unknown	1 mg	Subcutaneous
Background	Dexamethasone	Small molecule	—	—