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Phase II Rolapitant-Varubi (Newly diagnosed Glioma) - Clinical Trial

What is the Purpose of this Study?

We are doing this study to look at how well Rolapitant and Ondansetron works to help control nausea and vomiting in malignant glioma patients receving radiation therapy and chemotherapy (temozolomide).

What is the Condition Being Studied?

Newly diagnosed with Malignant Glioma Brain Cancer

Who Can Participate in the Study?

Adults who:
- Are diagnosed with malignant glioma (brain cancer)
- Are scheduled to get radiation therapy in combination with chemotherapy (temozolomide)
- Are not currently taking a medication to help prevent nausea and vomiting

Age Group
Adults

What is Involved?

If you join this study, you will:
- Be randomized (put into one of two groups by chance like a flip of a coin) to get:
-- Group A: Ondansetron daily for 6 weeks with 1 dose of Rolapitant on day 22
-- Group B: Ondansetron daily for 6 weeks with 1 dose of Rolapitant on day 1
- Be asked to complete questionnaires, keep a medication log and track any nausea and vomiting that you may have while you are on the study
- Be in this study for the 6 weeks of radiation and will have one follow-up contact 2 weeks after you finish the study

Study Details

Full Title
Phase II randomized study to evaluate efficacy, patient satisfaction, and compliance of the oral combination of Rolapitant (Varubi®) plus ondansetron vs. ondansetron monotherapy in malignant glioma patients receiving radiotherapy (RT) and concomitant temozolomide
Principal Investigator
Mary Affronti
Protocol Number
IRB:PRO00076418
NCT:NCT02991456
Phase
Phase II
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698