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: Completed Phase 3 study, sponsored by Heron Therapeutics.
NCT02106494 is a Phase 3 study that has completed, run by Heron Therapeutics. The registered enrollment target is 942 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (22% higher). According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
Percentage of Participants with no emesis and no rescue medication in patients receiving HEC in the delayed phase (24 to 120 hours) of CINV.
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 |
What the finished NCT02106494 record still lists
NCT02106494 is an interventional study that assigns participants to a tested intervention. The registered 942 participants enrollment target is mid-sized for trials with a published cap, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (22% higher).
The record links to 0 conditions, and to 5 interventions - of which Ondansetron is the first listed.
NCT02106494 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT02106494's enrollment target sits among peer trials
942 335th of 2000 higher than 1,664 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT06808334 · 942 participants
CLAiR Pivotal Study
- NCT07190209 · 942 participants · Phase 3
Efficacy, Safety, and Tolerability Study of Lunsekimig Compared With Placebo in Adult Participants With Inadequately Controlled Chronic Obstructive Pulmonary Disease (COPD) Characterized by an Eosinophilic Phenotype
- NCT07190222 · 942 participants · Phase 3
Efficacy, Safety, and Tolerability Study of Lunsekimig Compared With Placebo in Adult Participants With Inadequately Controlled Chronic Obstructive Pulmonary Disease (COPD), Characterized by an Eosinophilic Phenotype
- NCT05020236 · 944 participants · Phase 3
A Study to Learn About the Study Medicine Elranatamab Alone and With Daratumumab in People With Multiple Myeloma Who Have Received Other Treatments
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia