Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02106494 · ClinicalTrials.gov registry record · Phase 3
A Prospective, Multicenter, Study of APF530 (Granisetron) SC for Prevention of CINV in Patients Receiving HEC
A Phase 3 study, sponsored by Heron Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 942
- Enrollment target
NCT02106494 is a Phase 3 study that has completed, run by Heron Therapeutics. The registered enrollment target is 942 participants.
The verdict
NCT02106494, a Phase 3 study, has completed, sponsored by Heron Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 942 participants
- Enrollment target
Study Summary
The primary study objective is to demonstrate the superiority of APF530 500 mg given subcutaneously (SC) compared with ondansetron 0.15 mg/kg given intravenously (IV) (up to a maximum of 16 mg) in the delayed-phase (\> 24-120 hours) complete response (CR) rate (defined as no emesis and no use of rescue medications) in subjects receiving highly emetogenic chemotherapy (HEC) as defined by the 2011 ASCO CINV guidelines
Interventions
- DRUG Ondansetron
- DRUG APF530
- DRUG Fosaprepitant
- DRUG Ondansetron placebo
- DRUG APF530 placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 942 participants |
| Start Date | 2014-03 |
| Est. Completion | 2015-05 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02106494
The ClinicalTrials.gov registry entry for NCT02106494 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 942 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Heron Therapeutics, which has 23 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Ondansetron is the first listed.
NCT02106494 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02106494 about?
NCT02106494 is a clinical study titled "A Prospective, Multicenter, Study of APF530 (Granisetron) SC for Prevention of CINV in Patients Receiving HEC". The primary study objective is to demonstrate the superiority of APF530 500 mg given subcutaneously (SC) compared with ondansetron 0.15 mg/kg given intravenously (IV) (up to a maximum of 16 mg) in the delayed-phase (\> 24-120 hours) complete response (CR) rate (defined as no emesis and no use of res...
What is the current status of trial NCT02106494?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 942 participants. The study started on 2014-03. Estimated completion is 2015-05.
What interventions are being tested in trial NCT02106494?
The interventions under investigation include: Ondansetron (DRUG), APF530 (DRUG), Fosaprepitant (DRUG), Ondansetron placebo (DRUG), APF530 placebo (DRUG).
Who is sponsoring clinical trial NCT02106494?
This trial is sponsored by Heron Therapeutics, which has 23 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.