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NCT02991456 · ClinicalTrials.gov registry record · Phase 2
Rolapitant as an Antiemetic in Malignant Glioma Patients Receiving Radiotherapy and Temozolomide
A Phase 2 study, sponsored by Duke University.
- Completed
- Registry status
- Phase 2
- Development phase
- 48
- Enrollment target
NCT02991456: Completed Phase 2 study, sponsored by Duke University.
NCT02991456 is a Phase 2 study that has completed, run by Duke University. The registered enrollment target is 48 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (64% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02991456, a Phase 2 study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 48 participants
- Enrollment target
Study 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.
Primary Outcome
The Complete Response rate is defined as the proportion of participants with no emetic episode or the use of rescue medication during the first two weeks of radiation therapy and concomitant Temozolomide. The Complete Response rate will be assessed via the modified Multinational Association of Supportive Care in Cancer (MASCC) Antiemesis Tool (MAT).
Interventions
- DRUG Ondansetron
- DRUG Rolapitant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2017-10-09 |
| Est. Completion | 2022-06-20 |
| Phase | Phase 2 |
What the finished NCT02991456 record still lists
NCT02991456 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (64% lower).
The record links to 0 conditions, and to 2 interventions - of which Ondansetron is the first listed.
NCT02991456 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02991456 about?
NCT02991456 is a clinical study titled "Rolapitant as an Antiemetic in Malignant Glioma Patients Receiving Radiotherapy and Temozolomide". 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 ...
What is the current status of trial NCT02991456?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 48 participants. The study started on 2017-10-09. Estimated completion is 2022-06-20.
What interventions are being tested in trial NCT02991456?
The interventions under investigation include: Ondansetron (DRUG), Rolapitant (DRUG).
Who is sponsoring clinical trial NCT02991456?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02991456's enrollment target sits among peer trials
48 1265th of 2000 higher than 718 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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