A placebo-controlled study investigating the dexamethasone-sparing effects of corticorelin acetate in patients with primary or metastatic brain tumors and peritumoral edema

2078 Background: The standard therapy for patients with peritumoral edema (PTE) associated with cerebral tumors is long-term dexamethasone (dex), which is associated with significant short- and long-term adverse events (AEs). Corticorelin acetate (CrA) is a synthetic peptide of corticotropin-releasing factor that may have the potential to allow such patients to reduce or stop dex therapy. This study investigated the steroid-sparing effect of CrA in patients with cerebral tumors and PTE. Methods: Patients were randomized to CrA 1.0 mg bid SC (n = 100) or placebo (PLA) SC (n = 100) for 12 weeks. The primary endpoint was the percentage of responders, defined as patients able to reduce their daily dex dose by ≥50% by week 2 and maintain this reduction until week 5, without deterioration in neurologic or performance status. Secondary endpoints included maximum percent dex dose reduction from baseline and proximal myopathy (Kendall Myopathy Scale). Steroid-specific treatment-emergent AEs (TEAEs) were also evalu...