Armodafinil in Reducing Cancer-Related Fatigue in Patients With High Grade Glioma

Phase 3 Completed 328 enrolled Alliance for Clinical Trials in Oncology National Cancer Institute (NCI) · collab

RandomizedParallel-groupDouble-blindSupportive care

Summary

This randomized phase III trial studies armodafinil to see how well it works in reducing cancer-related fatigue in patients with high grade glioma. Armodafinil may help relieve fatigue in patients with high grade glioma.

Timeline

Start: 2013-06-21
Primary completion: 2019-05
Completion: 2019-12-15

Outcome

Missed primary endpoint

registry analysis (superiority test); Arm I (150 mg Armodafinil) vs Arm II (250 mg Armodafinil) vs Arm III (Placebo); p = 0.9601; Fisher Exact NCT01781468 ↗

paper There was no difference in the proportion of patients who achieved clinically meaningful fatigue reduction between arms PMID 34882169 ↗

Publications

Porter AB, Liu H, Kohli S, Cerhan JL, Sloan J, McMurray RP, Le-Rademacher J, Loprinzi CL, Villano JL, Kizilbash SH, Mehta MP, Jaeckle KA, Brown PD. Efficacy of Treatment With Armodafinil for Cancer-Related Fatigue in Patients With High-grade Glioma: A Phase 3 Randomized Clinical Trial. JAMA Oncol. 2022 Feb 1;8(2):259-267. doi: 10.1001/jamaoncol.2021.5948.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Armodafinil	Small molecule	150 mg	Oral
Subject	Armodafinil	Small molecule	250 mg	Oral

Indications

No indication recorded.