At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 405 enrolled
Drug / intervention
Pro-netupitant/Palonosetron +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3, Multicenter, Randomized, Double-blind, Active Control Study to Evaluate the Safety and Efficacy of IV Pro-netupitant/Palonosetron (260 mg/0.25 mg) Combination for the Prevention of Chemotherapy-induced Nausea and Vomiting in Repeated Chemotherapy Cycles in Patients Receiving Highly Emetogenic Chemotherapy
In Brief
A Phase 3 clinical trial evaluating Pro-netupitant/Palonosetron, Netupitant/Palonosetron, and 1 other intervention for Chemotherapy-Induced Nausea and Vomiting. Completed, enrolled 405 participants across 74 sites in 12 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChemotherapy-Induced Nausea and Vomiting
CountriesAustria, Croatia, Czechia, Germany, Israel, Italy, Poland, Serbia, South Africa, Spain, Ukraine, United States
CollaboratorsPSI CRO
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedAug 2015
Enrollment StartNov 2015
Primary CompletionAug 2016
TodayJul 2026
First PostedAug 6, 2015
Enrollment StartNov 1, 2015
Primary CompletionAug 1, 2016
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 10.9 years ago
Interventions
Pro-netupitant/Palonosetrondrug
Netupitant/Palonosetrondrug
Dexamethasonedrug