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NCT02517021 · ClinicalTrials.gov registry record · Phase 3
A Safety Study of Intravenous Pro-Netupitant and Palonosetron Combination for the Prevention of Nausea and Vomiting
A Phase 3 study, sponsored by Helsinn Healthcare.
- Completed
- Registry status
- Phase 3
- Development phase
- 405
- Enrollment target
NCT02517021: Completed Phase 3 study, sponsored by Helsinn Healthcare.
NCT02517021 is a Phase 3 study that has completed, run by Helsinn Healthcare. The registered enrollment target is 405 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (48% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02517021, a Phase 3 study, has completed, sponsored by Helsinn Healthcare.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 405 participants
- Enrollment target
Study Summary
NEPA-15-18 is a clinical study assessing safety of pro-netupitant and palonosetron, two antiemetic drugs, given with oral dexamethasone. The objective of the study is to evaluate if pro-netupitant and palonosetron are safe when administered to prevent nausea and vomiting after administration of repeated cycles of chemotherapy.
Primary Outcome
This is a safety study where Adverse Events is the primary outcome (defined by the current ICH Guideline for Good Clinical Practice). Patients are randomized according to a 1:1 ratio (IV NEPA FDC : oral NEPA FDC). No formal comparison is planned, the presence of a control in the same patient population helps interpret any unexpected safety finding in the experimental arm. It is expected that the number of patients randomized to the test group, i.e., 200, will allow approximately 100 patients to
Interventions
- DRUG Dexamethasone
- DRUG Pro-netupitant/Palonosetron
- DRUG Netupitant/Palonosetron
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 405 participants |
| Start Date | 2015-11 |
| Est. Completion | 2016-08 |
| Phase | Phase 3 |
What the finished NCT02517021 record still lists
NCT02517021 is an interventional study that assigns participants to a tested intervention. The registered 405 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (48% lower).
The record links to 0 conditions, and to 3 interventions - of which Dexamethasone is the first listed.
NCT02517021 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02517021 about?
NCT02517021 is a clinical study titled "A Safety Study of Intravenous Pro-Netupitant and Palonosetron Combination for the Prevention of Nausea and Vomiting". NEPA-15-18 is a clinical study assessing safety of pro-netupitant and palonosetron, two antiemetic drugs, given with oral dexamethasone. The objective of the study is to evaluate if pro-netupitant and palonosetron are safe when administered to prevent nausea and vomiting after administration of repe...
What is the current status of trial NCT02517021?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 405 participants. The study started on 2015-11. Estimated completion is 2016-08.
What interventions are being tested in trial NCT02517021?
The interventions under investigation include: Dexamethasone (DRUG), Pro-netupitant/Palonosetron (DRUG), Netupitant/Palonosetron (DRUG).
Who is sponsoring clinical trial NCT02517021?
This trial is sponsored by Helsinn Healthcare, which has 18 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02517021's enrollment target sits among peer trials
405 914th of 2000 higher than 1,087 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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