CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 401 enrolled
Drug / intervention
Olanzapine +3 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/NCT02116530
NCT02116530Phase 3Completed
CompareCT.gov

Olanzapine for the Prevention of Chemotherapy Induced Nausea and Vomiting (CINV) in Patients Receiving Highly Emetogenic Chemotherapy (HEC): A Randomized, Double-Blind, Placebo-Controlled Trial

Alliance for Clinical Trials in Oncology·interventional·Posted Apr 17, 2014·Updated Jan 28, 2025

In Brief

A Phase 3 clinical trial evaluating Olanzapine, Chemotherapy (cisplatin or cyclophosphamide and doxorubicin), and 2 other interventions for Hematopoietic/Lymphoid Cancer and 2 related conditions. Completed, enrolled 401 participants across 177 sites.

Detailed Summary

This randomized phase III trial studies antiemetic therapy with olanzapine to see how well they work compared to antiemetic therapy alone in preventing chemotherapy-induced nausea and vomiting in patients with cancer receiving highly emetogenic (causes vomiting) chemotherapy. Antiemetic drugs, such as palonosetron hydrochloride, ondansetron, and granisetron hydrochloride, may help lessen or prevent nausea and vomiting in patients treated with chemotherapy. Olanzapine may help prevent chemotherapy-induced nausea and vomiting by blocking brain receptors that appear to be involved in nausea and vomiting.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHematopoietic/Lymphoid Cancer, Nausea and Vomiting, Unspecified Adult Solid Tumor, Protocol Specific
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedApr 17, 2014
Enrollment StartAug 20, 2014
Primary CompletionApr 4, 2015
Study CompletionJun 15, 2017
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 12.2 years ago

Interventions

Olanzapinedrug

oral

Chemotherapy (cisplatin or cyclophosphamide and doxorubicin)drug

oral or IV

Antiemetic treatment (ondansetron or granisetron or palonosetron; plus dexamethasone; plus fosaprepitant or aprepitant)drug

oral or IV

Placeboother

oral