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Olanzapine With or Without Fosaprepitant Dimeglumine in Preventing Chemotherapy Induced Nausea and Vomiting in Cancer Patients Receiving Highly Emetogenic Chemotherapy

NCT03578081 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 690

Last updated 2025-04-06

Study results available
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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.

Conditions

  • Malignant Neoplasm

Interventions

DRUG

Palonosetron Hydrochloride

Given IV

DRUG

Ondansetron Hydrochloride

Given IV or PO

DRUG

Dexamethasone

Given PO

DRUG

Fosaprepitant Dimeglumine

Given IV

DRUG

Olanzapine

Given PO

OTHER

Placebo

Given IV

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Alliance for Clinical Trials in Oncology

    lead OTHER

Principal Investigators

  • Rudolph Navari, MD, PhD, FACP · University of Alabama at Birmingham

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-20
Primary Completion
2021-11-08
Completion
2023-05-01
FDA Drug
Yes

Countries

  • United States
  • Guam

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03578081 on ClinicalTrials.gov