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Antipsychotic

Fosaprepitant Dimeglumine for Cancer

Phase 3

Waitlist Available

Research Sponsored by Alliance for Clinical Trials in Oncology

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

Study Summary

This trial investigates whether olanzapine, with or without fosaprepitant, can prevent chemotherapy-induced nausea and vomiting.

Eligible Conditions

Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

No Nausea Rate Defined as a Response of 0 in the Nausea Item of Nausea and Vomiting Daily Diary/Questionnaire in the Overall (0-120 Hours), Acute (0-24 Hours), and Delayed (24-120 Hours) Periods

Secondary outcome measures

Average Nausea Scores (0-10) Repeatedly Measured by the Nausea and Vomiting Daily Diary/Questionnaire

Complete Response (CR) (no Emetic Episodes and no Use of Rescue Medication) During the Acute, Delayed and the Overall Periods as Measured by the Nausea and Vomiting Daily Diary/Questionnaire

Potential Toxicities as Ascribed to Olanzapine as Measured by the Nausea and Vomiting Daily Diary/Questionnaire

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm I (fosaprepitant dimeglumine, olanzapine)Experimental Treatment5 Interventions

Patients receive palonosetron hydrochloride IV over 30 seconds or ondansetron hydrochloride IV over 2-5 minutes or PO on day 1, dexamethasone PO on days 1-4, fosaprepitant dimeglumine IV over 20-30 minutes on day 1, and olanzapine PO on days 1-4. Treatment may repeat every 4 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.

Group II: Arm II (placebo, olanzapine)Active Control5 Interventions

Patients receive palonosetron hydrochloride IV over 30 seconds or ondansetron hydrochloride IV over 2-5 minutes or PO on day 1, dexamethasone PO on days 1-4, placebo IV over 20-30 minutes on day 1, and olanzapine PO on days 1-4. Treatment (with no placebo) may repeat every 4 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ondansetron Hydrochloride

2018

Completed Phase 3

~840

Dexamethasone

2007

Completed Phase 4

~2590

Fosaprepitant Dimeglumine

2018

Completed Phase 4

~800

Palonosetron Hydrochloride

2011

Completed Phase 4

~2820

Olanzapine

2005

Completed Phase 4

~5480

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,932,463 Total Patients Enrolled

Alliance for Clinical Trials in OncologyLead Sponsor

512 Previous Clinical Trials

216,948 Total Patients Enrolled

Rudolph Navari, MD, PhD, FACPStudy ChairUniversity of Alabama at Birmingham

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there a high chance of people experiencing negative side effects from Fosaprepitant Dimeglumine?

"Fosaprepitant Dimeglumine is considered safe, as it has reached Phase 3 in clinical trials. This demonstrates that not only is there some evidence of the medication being effective, but also that there have been multiple rounds of testing affirming its safety."

Answered by AI

Can you tell me about other times Fosaprepitant Dimeglumine has been studied in a clinical setting?

"Fosaprepitant Dimeglumine was first studied in 2002 at Manitoba Blood & Marrow Transplant Program CancerCare Manitoba. There have been a total of 19658 completed clinical trials as of now. Currently, 613 live studies are being conducted, with many of them taking place in Caro, Michigan."

Answered by AI

What are the main conditions that Fosaprepitant Dimeglumine has been shown to be effective against?

"Ophthalmia, sympathetic is often treated with Fosaprepitant Dimeglumine. This medication can also help patients that suffer from branch retinal vein occlusion, macular edema, and communicable diseases."

Answered by AI

How many individuals are given the opportunity to participate in this investigation?

"This trial is not recruiting patients at the moment. However, it was first posted on October 15th 2018 and updated as recently as January 6th, 2022. If you are looking for other studies, there are 2550 trials involving vomiting and 613 trials studying Fosaprepitant Dimeglumine that are currently admitting patients."

Answered by AI

Are there different sites in this city where I can participate in the trial?

"Currently, this clinical trial has 100 spots open at various hospitals and treatment centers including Caro Cancer Center, Genesee Cancer and Blood Disease Treatment Center, and Mayo Clinic in Arizona."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2018. "Olanzapine With or Without Fosaprepitant Dimeglumine in Preventing Chemotherapy Induced Nausea and Vomiting in Cancer Patients Receiving Highly Emetogenic Chemotherapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03578081.