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NCT03403712 · ClinicalTrials.gov registry record · Phase 3
A Study to Assess the Safety and the Efficacy of IV Fosnetupitant/Palonosetron (260 mg/0.25 mg) Combination Compared to Oral Netupitant/Palonosetron (300 mg/0.5 mg) Combination for the Prevention of CINV in AC Chemotherapy in Women With Breast Cancer
A Phase 3 study, sponsored by Helsinn Healthcare.
- Completed
- Registry status
- Phase 3
- Development phase
- 404
- Enrollment target
NCT03403712 is a Phase 3 study that has completed, run by Helsinn Healthcare. The registered enrollment target is 404 participants.
The verdict
NCT03403712, a Phase 3 study, has completed, sponsored by Helsinn Healthcare.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 404 participants
- Enrollment target
Study Summary
Multicenter, randomized, double-blind, double-dummy, parallel group, stratified study assessing the safety and describing the efficacy of a single dose of intravenous (IV) fosnetupitant/palonosetron (260 mg/0.25 mg) infusion \[test\] versus oral netupitant/palonosetron (300 mg/0.5 mg) combination \[control\]; each administered with oral dexamethasone prior to initial and repeated cycles of AC chemotherapy in female breast cancer patients.
Interventions
- DRUG dexamethasone
- DRUG fosnetupitant/ palonosetron
- DRUG netupitant/palonosetron
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 404 participants |
| Start Date | 2018-03-16 |
| Est. Completion | 2018-09-19 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03403712
The ClinicalTrials.gov registry entry for NCT03403712 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 404 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Helsinn Healthcare, which has 18 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which dexamethasone is the first listed.
NCT03403712 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03403712 about?
NCT03403712 is a clinical study titled "A Study to Assess the Safety and the Efficacy of IV Fosnetupitant/Palonosetron (260 mg/0.25 mg) Combination Compared to Oral Netupitant/Palonosetron (300 mg/0.5 mg) Combination for the Prevention of CINV in AC Chemotherapy in Women With Breast Cancer". Multicenter, randomized, double-blind, double-dummy, parallel group, stratified study assessing the safety and describing the efficacy of a single dose of intravenous (IV) fosnetupitant/palonosetron (260 mg/0.25 mg) infusion \[test\] versus oral netupitant/palonosetron (300 mg/0.5 mg) combination \[...
What is the current status of trial NCT03403712?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 404 participants. The study started on 2018-03-16. Estimated completion is 2018-09-19.
What interventions are being tested in trial NCT03403712?
The interventions under investigation include: dexamethasone (DRUG), fosnetupitant/ palonosetron (DRUG), netupitant/palonosetron (DRUG).
Who is sponsoring clinical trial NCT03403712?
This trial is sponsored by Helsinn Healthcare, which has 18 total clinical trials registered on ClinicalTrials.gov.
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