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NCT03578081 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Malignant Neoplasm, sponsored by Alliance for Clinical Trials in Oncology.

Completed
Registry status
Phase 3
Development phase
690
Enrollment target
20
Study locations

NCT03578081 is a Phase 3 study of Malignant Neoplasm that has completed, run by Alliance for Clinical Trials in Oncology. The registered enrollment target is 690 participants, above the 502-participant average among 59 other Malignant Neoplasm trials with a reported enrollment target (37% higher). The trial reports 20 study locations across 6 states.

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The verdict

NCT03578081, a Phase 3 study of Malignant Neoplasm, has completed, sponsored by Alliance for Clinical Trials in Oncology.

COMPLETED
Registry status
Phase 3
Development phase
690 participants
Enrollment target
20
Study locations

Study 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 Studied

Interventions

  • DRUG Dexamethasone
  • DRUG Olanzapine
  • DRUG Palonosetron Hydrochloride
  • DRUG Ondansetron Hydrochloride
  • DRUG Fosaprepitant Dimeglumine

Study Locations (20)

California

  • PCR Oncology - Arroyo Grande
  • Epic Care-Dublin - Dublin
  • Bay Area Breast Surgeons Inc - Emeryville
  • Epic Care Partners in Cancer Care - Emeryville
  • Tibor Rubin VA Medical Center - Long Beach
  • Contra Costa Regional Medical Center - Martinez
  • Alta Bates Summit Medical Center - Summit Campus - Oakland
  • Bay Area Tumor Institute - Oakland
  • Desert Regional Medical Center - Palm Springs
  • Epic Care Cyberknife Center - Walnut Creek

Arizona

  • Kingman Regional Medical Center - Kingman
  • Mayo Clinic Hospital in Arizona - Phoenix
  • Mayo Clinic in Arizona - Scottsdale

Colorado

  • Rocky Mountain Cancer Centers-Aurora - Aurora
  • The Medical Center of Aurora - Aurora
  • Boulder Community Hospital - Boulder

Arkansas

  • Mercy Hospital Fort Smith - Fort Smith
  • Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro - Jonesboro

Alabama

  • University of Alabama at Birmingham Cancer Center - Birmingham

Alaska

  • Fairbanks Memorial Hospital - Fairbanks

Trial Details

FieldValue
Enrollment Target 690 participants
Start Date 2018-11-20
Est. Completion 2023-05-01
Phase Phase 3

What the Registry Record Tells You About NCT03578081

The ClinicalTrials.gov registry entry for NCT03578081 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 690 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 502-participant average among 59 other Malignant Neoplasm trials with a reported enrollment target (37% higher). The listed sponsor is Alliance for Clinical Trials in Oncology, which has 446 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Malignant Neoplasm appearing as the primary indexed condition, and to 5 interventions - of which Dexamethasone is the first listed.

NCT03578081 reports 20 study locations spanning 6 distinct geographic areas - top geographies include California, Arizona, Colorado.

Frequently Asked Questions

What is clinical trial NCT03578081 about?

NCT03578081 is a clinical study titled "Olanzapine With or Without Fosaprepitant Dimeglumine in Preventing Chemotherapy Induced Nausea and Vomiting in Cancer Patients Receiving Highly Emetogenic Chemotherapy". 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 patie...

What is the current status of trial NCT03578081?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 690 participants. The study started on 2018-11-20. Estimated completion is 2023-05-01.

What conditions does trial NCT03578081 study?

This clinical trial studies the following conditions: Malignant Neoplasm.

What interventions are being tested in trial NCT03578081?

The interventions under investigation include: Dexamethasone (DRUG), Olanzapine (DRUG), Palonosetron Hydrochloride (DRUG), Ondansetron Hydrochloride (DRUG), Fosaprepitant Dimeglumine (DRUG).

Who is sponsoring clinical trial NCT03578081?

This trial is sponsored by Alliance for Clinical Trials in Oncology, which has 446 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03578081 being conducted?

This trial has 20 study locations across Alabama, Alaska, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.