CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 85 enrolled
Drug / intervention
Palonosetron +2 moredrug
Likely dose
Palonosetron 8mgfrom 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/NCT01370408
NCT01370408Phase 2Completed

A Unique Schedule of Palonosetron, Ondansetron, and Dexamethasone for the Prevention of Delayed Nausea and Vomiting in Patients Receiving Moderately Emetogenic Myeloablative Chemotherapy

Northside Hospital, Inc.·interventional·Posted Jun 9, 2011·Updated Apr 17, 2017

In Brief

A Phase 2 clinical trial evaluating Palonosetron, ondansetron, and 1 other intervention for Chemotherapy-induced Nausea and Vomiting. Completed, enrolled 85 participants across 1 site.

Detailed Summary

In this study, patients will receive ondansetron 8mg and dexamethasone 10mg intravenously 30 minutes prior to myeloablative preparative chemotherapy until the last day of chemotherapy. On the final day of chemotherapy, palonosetron 0.25mg and dexamethasone 10mg will be administered intravenously 30 minutes prior to the chemotherapy. If the chemotherapy regimen is only 1 day of the chemotherapy then only palonosetron and dexamethasone will be administered 30 minutes prior to chemotherapy. Dexamethasone 8mg once daily will be given orally for 2 days following chemotherapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJun 9, 2011
Enrollment StartFeb 1, 2012
Primary CompletionMar 1, 2016
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 15.1 years ago

Interventions

Palonosetrondrug

Prior to IV chemotherapy - ondansetron 8mg IV \& Dexamethasone 10 mg IV On the last day of chemotherapy - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO

ondansetrondrug

Prior to IV chemotherapy - ondansetron 8mg IV \& Dexamethasone 10 mg IV On the last day of chemotherapy - Palonosetron .25 mg IV, dexamethasone 10mg IV

Dexamethasonedrug

Prior to IV chemotherapy - ondansetron 8mg IV \& Dexamethasone 10 mg IV On the last day of chemotherapy - Palonosetron .25 mg IV, dexamethasone 10mg IV