CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 48 enrolled
Drug / intervention
Rolapitant +1 moredrug
Likely dose
Rolapitant 180 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02991456
NCT02991456Phase 2Completed
CompareCT.gov

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

Duke University·interventional·Posted Dec 13, 2016·Updated Jul 11, 2023

In Brief

A Phase 2 clinical trial evaluating Rolapitant and Ondansetron for Chemo-radiation Induced Nausea and Vomiting. Completed, enrolled 48 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChemo-radiation Induced Nausea and Vomiting
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedDec 13, 2016
Enrollment StartOct 9, 2017
Primary CompletionMay 9, 2022
Study CompletionJun 20, 2022
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 9.6 years ago

Interventions

Rolapitantdrug

single 180 mg dose by mouth

Ondansetrondrug

8 mg by mouth daily