Fosaprepitant for Nausea and Vomiting

(AFTR NV RCT Trial)

Recruiting at 1 trial location

Overseen By Mustfa K Manzur, MD MPH MS

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Montefiore Medical Center

Must not be taking: Antiemetics

Disqualifiers: Pregnancy, Bradycardia, Dementia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 25

Duration: 2 hours

250 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment for nausea and vomiting using a drug called fosaprepitant. Fosaprepitant acts in the brain to block the signals that cause vomiting. Researchers will compare it to ondansetron, a standard treatment, to determine which works better and has fewer side effects. Individuals still experiencing nausea two hours after receiving treatment in an emergency department might be suitable for this trial. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important medical advancements.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes those who have used antiemetics or received intravenous fluids before screening.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that fosaprepitant is generally safe. Studies report no deaths among patients taking this medication. Fosaprepitant is typically used to prevent nausea and vomiting from chemotherapy or surgery, indicating its safe use by many patients.

One study found that patients who took fosaprepitant experienced less nausea after surgery compared to those who did not. This suggests that the medication is effective and causes few side effects.

Overall, fosaprepitant appears to be a safe option for managing nausea and vomiting. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Fosaprepitant is unique because it targets nausea and vomiting by blocking the neurokinin-1 (NK1) receptors, which play a key role in the body's emetic (vomiting) response. Unlike standard treatments like ondansetron, which primarily block serotonin receptors, fosaprepitant offers a different approach that may enhance overall anti-nausea effectiveness, especially in patients who do not respond well to serotonin receptor blockers alone. Researchers are excited about this treatment because it has the potential to provide more comprehensive relief from nausea and vomiting, particularly in cases where current options fall short.

What evidence suggests that fosaprepitant might be an effective treatment for nausea and vomiting?

Research has shown that fosaprepitant, which participants in this trial may receive, helps reduce nausea and vomiting. In one study, 76.2% of patients taking aprepitant (the active form of fosaprepitant) did not vomit, compared to 62.1% in the group not taking it. Another study found that fosaprepitant significantly reduced nausea over several days. It blocks a key signal in the brain that causes vomiting. Overall, fosaprepitant is generally well-tolerated and effective for managing these symptoms. ^{1 3 4 5 6}

Who Is on the Research Team?

Benjamin W Friedman, MD

Principal Investigator

Montefiore Medical Center

Are You a Good Fit for This Trial?

This trial is for patients experiencing nausea and vomiting who are seeking a potentially more effective treatment. Participants should not have used any other antiemetic medication recently and must be in need of immediate relief from their symptoms.

Inclusion Criteria

I am experiencing nausea or vomiting.

Exclusion Criteria

Bradycardia (less than 60 bpm heart rate)

Pregnancy, desiring pregnancy, or lactating

Dementia

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either fosaprepitant or ondansetron intravenously to assess efficacy and adverse event profile

2 hours

1 visit (in-person)

Follow-up

Participants are monitored for sustained relief from nausea and vomiting and other secondary outcomes

24 hours

Continuous monitoring for 24 hours

What Are the Treatments Tested in This Trial?

Interventions

• Fosaprepitant

Trial Overview The study compares the effectiveness of Fosaprepitant, a newer antiemetic drug, with Ondansetron, a standard treatment. It's randomized and double-blind, meaning neither the doctors nor patients know who gets which drug to ensure unbiased results.

How Is the Trial Designed?

Group I: Investigational Intervention Experimental Treatment 1 Intervention

Fosaprepitant 150mg IV administered over 15 minutes

Group II: Standard-of-Care Intervention Active Control 1 Intervention

Ondansetron 4mg IV administered over 15 minutes

Fosaprepitant is already approved in United States, European Union for the following indications:

Approved in United States as Emend for:

• Prevention of acute and delayed nausea and vomiting associated with highly emetogenic cancer chemotherapy
• Prevention of delayed nausea and vomiting associated with moderately emetogenic cancer chemotherapy

Approved in European Union as Emend for:

• Prevention of acute and delayed nausea and vomiting associated with highly emetogenic cancer chemotherapy
• Prevention of delayed nausea and vomiting associated with moderately emetogenic cancer chemotherapy

Who Is Running the Clinical Trial?

Montefiore Medical Center

Lead Sponsor

Trials

468

Recruited

599,000+

Published Research Related to This Trial

Intravenous fosaprepitant is an effective antiemetic for preventing nausea and vomiting in adult cancer patients undergoing highly and moderately emetogenic chemotherapy, showing good efficacy in large phase III trials with a single 150 mg dose.

Fosaprepitant is well tolerated and has a safety profile similar to that of oral aprepitant, making it a valuable addition to standard antiemetic regimens that include dexamethasone and serotonin 5-HT3 receptor antagonists.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fosaprepitant Dimeglumine: A Review in the Prevention of Nausea and Vomiting Associated with Chemotherapy. Garnock-Jones, KP.[2018]

In a study of 57 patients receiving intravenous fosaprepitant for chemotherapy-induced nausea and vomiting, 40% experienced infusion site reactions, indicating a higher incidence than previously reported.

Key risk factors for these reactions included older age, the site of infusion (particularly at the back of the hand and wrist), and being a first-time recipient of fosaprepitant, all with significant statistical correlations (P < .001).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incidence of Infusion Site Reactions in Peripheral Fosaprepitant Infusions. Gonçalves, SC., Sanches, SM., Bueno, CT., et al.[2018]

Fosaprepitant is an intravenous prodrug of aprepitant, which converts to the active drug within 30 minutes, providing a rapid option for preventing chemotherapy-induced nausea and vomiting (CINV).

Clinical studies suggest that 115 mg of fosaprepitant is equivalent to 125 mg of oral aprepitant, and it has been approved by the FDA and EMEA as part of a standard CINV prevention regimen, showing similar tolerability to the oral form.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fosaprepitant dimeglumine (MK-0517 or L-785,298), an intravenous neurokinin-1 antagonist for the prevention of chemotherapy induced nausea and vomiting. Van Belle, SJ., Cocquyt, V.[2019]

In a study of 868 patients receiving fosaprepitant for chemotherapy-induced nausea and vomiting, only 0.461% experienced systemic hypersensitivity reactions, aligning with the reported incidence of less than 1% in existing literature.

The findings suggest that while hypersensitivity reactions to fosaprepitant are rare, there is a need for improved education and documentation regarding these reactions to enhance patient safety and care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of fosaprepitant-associated hypersensitivity reactions at a National Cancer Center. Laird, CM., Glode, AE., Schwarz, K., et al.[2020]

Fosaprepitant, a neurokinin-1 receptor antagonist, is effective and safe for preventing chemotherapy-induced nausea and vomiting (CINV) in cancer patients undergoing highly emetogenic chemotherapy, offering a promising alternative to traditional antiemetic therapies.

As an intravenous formulation, fosaprepitant overcomes the limitations of oral aprepitant, potentially improving patient compliance and quality of life during chemotherapy treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The clinical research study for fosaprepitant to prevent chemotherapy-induced nausea and vomiting: A review. Xue, F., Liu, X., Qi, X., et al.[2023]

Fosaprepitant is an effective antiemetic used primarily for patients undergoing moderately to highly emetogenic chemotherapy, but it can cause local injection site reactions, which are the most common infusion-related issues.

This report highlights two cases of systemic hypersensitivity reactions to fosaprepitant infusions, suggesting that while generally safe, there may be rare but serious allergic responses that healthcare providers should monitor.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systemic hypersensitivity to fosaprepitant - A report of two cases. Baxley, A., Lee, Z., Medina, P.[2018]

A practice change to dilute fosaprepitant to 150 mg/250 ml and infuse it over 30 minutes significantly reduced the incidence of infusion-site reactions from 28.7% to 5.74% in cancer patients receiving the medication.

This study, which reviewed the medical records of 122 patients, suggests that the new administration method improves patient tolerance and should be considered by oncology pharmacists for better safety outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Updated report on incidence of infusion-site reactions associated with peripheral intravenous administration of fosaprepitant. Chau, E., Lundberg, J., Phillips, G., et al.[2019]

In a study of 81 patients receiving non-anthracycline platinum-based chemotherapy, fosaprepitant was associated with a 7.4% incidence of infusion site adverse events (ISAE), including swelling, extravasation, and phlebitis.

Patients receiving platinum-based chemotherapy experienced significantly lower rates of ISAE compared to those receiving anthracycline-based regimens, indicating that the type of chemotherapy influences the risk of adverse events related to fosaprepitant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An analysis of fosaprepitant-induced venous toxicity in patients receiving highly emetogenic chemotherapy. Hegerova, LT., Leal, AD., Grendahl, DC., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4391760/

Aprepitant and Fosaprepitant: A 10-Year Review of Efficacy ... Significantly more aprepitant recipients than controls achieved no vomiting (76.2% vs. 62.1%; p < .001) and complete response (68.7% vs. 56.3%; p < .001) in the ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06382012

Antiemetic Fosaprepitant To Remedy Nausea and Vomiting The primary outcome for the tolerability analysis will be the development of any new symptom within 2 hours of medication administration.

3. fda.gov fda.gov/media/172970/download

Focinvez (Fosaprepitant Injection) □ Clinical outcome assessment (COA) data, such as. □ Patient reported outcome (PRO). □ Observer reported outcome (ObsRO). □ Clinician ...

4. bmccancer.biomedcentral.com bmccancer.biomedcentral.com/articles/10.1186/s12885-025-13469-6

a complement to fosaprepitant in the prevention ... - BMC Cancer A recent study found that extended use of fosaprepitant on days 1 and 3 significantly reduced the incidence of nausea (6.17% vs. 12.66%, P = 0. ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0007091223003112

Fosaprepitant for postoperative nausea and vomiting in ... Our results revealed that participants in the fosaprepitant group had decreased PONV scores and fewer cases of clinically relevant PONV up to 72 h after surgery ...

6. tandfonline.com tandfonline.com/doi/full/10.1080/08880018.2024.2437047

Safety and Tolerability of a 3-Day Fosaprepitant Regimen ... Similar trends in safety outcomes were observed during cycles 2 and 3. No deaths were reported. The 3-day IV fosaprepitant regimen for the prevention of CINV ...