drugset / Trial / NCT02991456

Rolapitant as an Antiemetic in Malignant Glioma Patients Receiving Radiotherapy and Temozolomide

NCT02991456

Phase 2 Completed 48 enrolled Duke University
RandomizedCrossoverOpen-labelSupportive care

Summary

The purpose of this phase 2 study is to assess the efficacy and patient satisfaction of oral rolapitant plus ondansetron vs. oral ondansetron monotherapy in malignant glioma (MG) patients receiving standard of care radiation (RT) and temozolomide (TMZ) therapy. This is a randomized phase 2 trial of rolapitant plus ondansetron vs. ondansetron monotherapy for the prevention of chemo-radiation induced nausea and vomiting in primary MG subjects receiving RT and concomitant multi-dose TMZ.

Timeline

Start
2017-10-09
Primary completion
2022-05-09
Completion
2022-06-20

Drugs

EvaluationDrugModalityDoseRoute
Comparator Ondansetron Other / unclassified 8 mg Oral
Comparator Rolapitant Small molecule 180 mg Oral