At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 942 enrolled
Drug / intervention
APF530 +5 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 Clinical Study Protocol: A Prospective, Randomized, Placebo-Controlled, Double-Blind, Multicenter, Phase 3 Study of APF530 500 mg SC, Fosaprepitant 150 mg IV, and Dexamethasone vs. Ondansetron 0.15 mg/kg IV, Fosaprepitant 150 mg IV, and Dexamethasone for the Prevention of Chemotherapy-Induced Nausea and Vomiting in Patients Receiving Highly Emetogenic Chemotherapy
In Brief
A Phase 3 clinical trial evaluating APF530, Ondansetron, and 4 other interventions for Chemotherapy-induced Nausea and Vomiting. Completed, enrolled 942 participants across 7 sites.
Detailed 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
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChemotherapy-induced Nausea and Vomiting
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartMar 2014
First PostedApr 2014
Primary CompletionMay 2015
TodayJul 2026
First PostedApr 8, 2014
Enrollment StartMar 1, 2014
Primary CompletionMay 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 12.2 years ago
Interventions
APF530drug
Ondansetrondrug
Ondansetron placebodrug
APF530 placebodrug
Fosaprepitantdrug
Dexamethasonedrug