CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 690 enrolled
Drug / intervention
Palonosetron Hydrochloride +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.

Search/NCT03578081
NCT03578081Phase 3Completed

Olanzapine With or Without Fosaprepitant for the Prevention of Chemotherapy Induced Nausea and Vomiting (CINV)in Patients Receiving Highly Emetogenic Chemotherapy (HEC): A Phase III Randomized, Double Blind, Placebo-Controlled Trial

Alliance for Clinical Trials in Oncology·interventional·Posted Jul 5, 2018·Updated Apr 6, 2025

In Brief

A Phase 3 clinical trial evaluating Palonosetron Hydrochloride, Ondansetron Hydrochloride, and 4 other interventions for Malignant Neoplasm. Completed, enrolled 690 participants across 566 sites in 2 countries.

Detailed Summary

This randomized phase III trial studies how well olanzapine with or without fosaprepitant work in preventing chemotherapy induced nausea and vomiting in cancer patients receiving chemotherapy that causes vomiting. Olanzapine and fosaprepitant dimeglumine may help control nausea and vomiting in patients during chemotherapy. Olanzapine is usually given in combination with other drugs, including fosaprepitant dimeglumine. It is not yet known if olanzapine when given with other drugs, is still effective without using fosaprepitant dimeglumine for controlling nausea and vomiting.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesGuam, United States

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedJul 5, 2018
Enrollment StartNov 20, 2018
Primary CompletionNov 8, 2021
Study CompletionMay 1, 2023
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 8.0 years ago

Interventions

Palonosetron Hydrochloridedrug

Given IV

Ondansetron Hydrochloridedrug

Given IV or PO

Dexamethasonedrug

Given PO

Fosaprepitant Dimegluminedrug

Given IV

Olanzapinedrug

Given PO

Placeboother

Given IV