Recruiting
`Study With IV NEPA (Fosnetupitant/ Palonosetron) for the Prevention of
`Chemotherapy-induced Nausea and Vomiting in Paediatric Cancer Patients
`Undergoing Highly Emetogenic Chemotherapy (HEC)
`ClinicalTrials.gov ID NCT06904235
`Sponsor Helsinn Healthcare SA
`Information provided by Helsinn Healthcare SA (Responsible Party)
`Last Update Posted 2025-07-28
`Study Details Tab
`Study Overview
`Brief Summary
`Chemotherapy often causes nausea and vomiting (CINV), and this is a major problem for the children
`being treated for cancer. To prevent this, a combination of two substances in fixed proportion (IV NEPA)
`was developed. The two substances are: palonosetron, an antagonist of 5 HT3 receptors, and
`fosnetupitant, an antagonist of NK1 receptors that transforms into netupitant in the body. The
`medication is administered through intravenous injection (IV- drip).
`This study is built from 2 parts:
`Part 1: phase 2, open label Part 2: phase 3 double blind
`The detailed description, study design, study milestones and eligibility criteria will reflect the Part 1
`requirements
`The U.S. government does not review or approve the safety and science of all studies
`listed on this website.
`Read our full disclaimer(https://clinicaltrials.gov/about-site/disclaimer) for details.
`8/3/25, 4:09 PM Study Details | Study With IV NEPA (Fosnetupitant/Palonosetron) for the Prevention of Chemotherapy-induced Nausea and Vomiting…
`https://clinicaltrials.gov/study/NCT06904235 1/20
`HELSINN EXHIBIT 2029
`Azurity Pharmaceuticals, Inc. v. Helsinn Healthcare S.A.
`IPR2025-00945
`Page 1 of 20
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`Part I of the study is a Phase 2, open-label, randomised (for Cohort 1 only), single chemotherapy cycle
`study which will compare single-dose of IV NEPA to another treatment (fosaprepitant/ondansetron)
`considered as a standard of care, in patients receiving single-day chemotherapy that has a high
`possibility to generate a vomiting episode (HEC) (Cohort 1) and assess repeated dose of IV NEPA in
`patients receiving multi day HEC chemotherapy (Cohort 2).
`Because this will be the first study testing the IV NEPA in children, Part I will enroll patients from older to
`younger age groups with safety checks before moving to the next group.
`Official Title
`A Multicentre, Multinational, Pharmacokinetic, Safety, and Efficacy Study With IV NEPA
`(Fosnetupitant/Palonosetron) for the Prevention of Chemotherapy-induced Nausea and Vomiting in
`Paediatric Cancer Patients Undergoing Highly Emetogenic Chemotherapy (HEC). A 2-part Study With
`Phase 2, Open-label, Randomised, Single-dose IV NEPA vs Fosaprepitant/Ondansetron in Single-day
`HEC and Repeated-dose IV NEPA in Multi-day HEC (Part I, Single Cycle) and With Phase 3, Double-blind,
`Randomised, Repeated-dose IV NEPA vs Fosaprepitant/Ondansetron in Multi-day HEC (Part II, Repeated
`Cycles)
`Conditions
`Nausea and Vomiting Chemotherapy-InducedNausea Post Chemotherapy
`Intervention / Treatment
`Drug: IV NEPA (fosnetupitant/palonosetron)
`Drug: Reference Treatment: IV ondansetron infusion
`Drug: Reference Treatment: IV fosaprepitant infusion
`Other Study ID Numbers
`2024-514321-39 ( EudraCT Number )
`Study Start (Actual)
`2025-07-07
`Primary Completion (Estimated)
`2027-10
`Study Completion (Estimated)
`2027-12
`Detailed Description
`8/3/25, 4:09 PM Study Details | Study With IV NEPA (Fosnetupitant/Palonosetron) for the Prevention of Chemotherapy-induced Nausea and Vomiting…
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`Enrollment (Estimated)
`95
`Study Type
`Interventional
`Phase
`Phase 2
`Resource links provided by the National Library of Medicine
`MedlinePlus(https://medlineplus.gov/) related topics:  Nausea and
`Vomiting(https://medlineplus.gov/nauseaandvomiting.html)
`Drug Information(https://dailymed.nlm.nih.gov/dailymed/) available for: 
`Ondansetron(https://dailymed.nlm.nih.gov/dailymed/search.cfm?
`labeltype=human&query=Ondansetron)
`Palonosetron(https://dailymed.nlm.nih.gov/dailymed/search.cfm?
`labeltype=human&query=Palonosetron)
`Fosaprepitant(https://dailymed.nlm.nih.gov/dailymed/search.cfm?
`labeltype=human&query=Fosaprepitant)
`FDA Drug and Device Resources(https://clinicaltrials.gov/fda-links)
`Contacts and Locations
`This section provides contact details for people who can answer questions about joining this study, and
`information on where this study is taking place.
`To learn more, please see the Contacts and Locations section in How to Read a Study
`Record(https://clinicaltrials.gov/study-basics/how-to-read-study-record#contacts-and-locations).
`Study Contact
`Name: Tulla Spinelli Head of Clinical Affairs, PharmD, PhD
`Phone Number: +41919852121
`Email: tulla.spinelli@helsinn.com
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`This study has 18 locations
`Greece
`Athens, Greece
`Not yet recruiting
`Aghia Sophia Children's Hospital, Pediatric
`Hematology/ Oncology Unit (POHemU)
`Thessaloniki, Greece
`Not yet recruiting
`"AHEPA" University General Hospital of
`Thessaloniki, 2nd Department of Pediatrics
`Poland
`Bialystok, Poland
`Recruiting
`Department of Pediatrics, Oncology and
`Hematology University Children's Clinical
`Hospital them. Ludwik Zamenhof in Bialystok
`Olsztyn, Poland
`Not yet recruiting
`Clinical Department of Paediatric Oncology and
`Haematology VOIVODSHIP SPECIALIST
`CHILDREN'S HOSPITAL them. prof. dr. Stanisław
`Popowski in Olsztyn
`Poznan, Poland
`Recruiting
`Department of Pediatric Oncology, Hematology
`and Transplantation Clinical Hospital them.
`Karol Jonscher Medical University them. Karol
`Marcinkowski in Poznań
`Szczecin, Poland
`Not yet recruiting
`Department of Paediatrics and Paediatric
`Haemato-Oncology University Clinical Hospital
`No. 1 them. prof. Tadeusz Sokołowski
`Pomeranian Medical University
`Szczecin, Poland
`Recruiting
`Department of Paediatrics, Oncology and
`Paediatric Immunology, University Clinical
`Hospital No. 1 them. prof. Tadeusz Sokołowski
`Pomeranian Medical University in Szczecin
`Warsaw, Poland
`Recruiting
`Department of Oncology and Surgical Oncology
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`for Children and Youth Institute Mother and
`Child
`Warsaw, Poland
`Recruiting
`Department of Oncology Institute "Monument -
`Child Health Center"
`Łodz, Poland
`Not yet recruiting
`Clinic of Pediatrics, Oncology and Hematology
`University Pediatric Center them M. Konopnicka
`SP ZOZ Central Clinical Hospital Medical
`University of Lodz
`Romania
`Bucharest, Romania
`Recruiting
`Fundeni Clinical Institute, Pediatric Hematology
`and BMT
`Bucharest, Romania
`Recruiting
`Oncology Institute "Prof. Dr. Al. Trestioreanu",
`Pediatric Oncology
`Timisoara, Romania
`Recruiting
`Emergency Children's Hospital " Louis Turcanu,
`Oncology-Haematology and BMP department
`Turkey
`Ankara, Turkey
`Not yet recruiting
`Gazi University Gazi Hospital Children
`Hematology and Oncology
`Ankara, Turkey
`Not yet recruiting
`Hacettepe University Hospitals Oncology
`Hospital 2nd Floor Children Oncology
`Faith Locations
`Istanbul, Faith, Turkey
`Not yet recruiting
`Istanbul University Istanbul Faculty of Medicine
`Topkapı
`Mamak Locations
`Ankara, Mamak, Turkey
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`Not yet recruiting
`Ankara University Faculty of Medicine Children's
`Hospital, Department of Children Oncology and
`Hematology
`Melikgazi Locations
`Kayseri, Melikgazi, Turkey
`Not yet recruiting
`Erciyes University Hospitals Kanka Children's
`Hematology Oncology and Bone Marrow
`Hospital
`Participation Criteria
`Researchers look for people who fit a certain description, called eligibility criteria. Some examples of
`these criteria are a person's general health condition or prior treatments.
`For general information about clinical research, read Learn About
`Studies(https://clinicaltrials.gov/study-basics/learn-about-studies).
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`Eligibility Criteria
`Description
`Inclusion Criteria:
`The following inclusion criteria must be checked prior to study inclusion:
`1. Signed written Informed Consent Form (ICF) by parent(s)/legal guardian of the paediatric
`patient in compliance with the local laws and regulations. In addition, the signed children's
`Assent Form according to local requirements.
`2. Male or female in- or out-patient from 0 months (newborns) to <18 years on the date of
`enrolment (Day 1).
`3. Cohort 1: Patient < 6 months weighing at least 4 kg or patient ≥ 6 months weighing at least
`6 kg.
`Cohort 2: Patient weighing at least 4 kg.
`4. Patient with a predicted life expectancy ≥3 months according to Investigator's opinion.
`5. Patient naïve or non-naïve to chemotherapy, with histologically and/or cytologically (or
`imaging in the case of brain tumours and nephroblastomas) confirmed malignant disease.
`6. Cohort 1: Patient scheduled and eligible to receive at least 1 cycle of single-day HEC.
`Cohort 2: Patient scheduled and eligible to receive at least 1 cycle of multi-day HEC.
`(For the level of emetogenicity of the chemotherapeutic agents, refer to the POGO January
`2021 guideline).
`7. For patients aged ≥10 years: Eastern Cooperative Oncology Group Performance Status
`(ECOG PS) ≤2.
`8. For patient with known hepatic impairment: the patient may be enrolled provided the serum
`ALT and AST are ≤2.5 ULN, the total bilirubin is ≤1.5 ULN, and in the Investigator's opinion
`the impairment is not expected to jeopardize the patient's safety during the study.
`9. For patient with known renal impairment: the patient may be enrolled provided the
`estimated glomerular filtration rate (eGFR) is ≥70 mL/min/1.73m2 (≥50 mL/min/1.73m2 for
`children <3 months old) (the eGFR should be calculated using the modified Schwartz
`equation) and in the Investigator's opinion the impairment is not expected to jeopardize the
`patient's safety during the study.
`10. For patient with known history or predisposition to cardiac abnormalities: as per the
`Investigator's opinion, the history/predisposition should not jeopardize patient's safety
`during the study.
`11. Patient with non-clinically significant abnormal laboratory values or with clinically relevant
`abnormal laboratory values may be enrolled if in the Investigator's opinion the patient's
`safety is not expected to be jeopardized.
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`12. Female patient shall: a) not have attained menarche yet or b) have attained menarche and
`have a negative serum pregnancy test at the Screening Visit and a negative urine pregnancy
`test at Day 1.
`13. Male or female fertile patient using reliable contraceptive measures. Such measures, for
`patient and sexual partner, include: implants, injectables, combined oral contraceptives,
`intrauterine devices, vasectomized/sterilized partner, use of a double barrier method, or
`sexual abstinence. The patient and his/her parent(s)/legal guardian must be counselled on
`the importance of avoiding pregnancy before and during the study.
`Exclusion Criteria:
`1. The patient and/or parent(s)/legal guardian are expected by the Investigator to be non
`compliant with the study procedures.
`2. Patient has received or is scheduled to receive total body irradiation; total nodal irradiation;
`upper abdomen radiotherapy; half or upper body irradiation; or radiotherapy of the cranium,
`craniospinal regions, head and neck, lower thorax region, or the pelvis within 1 week prior to
`study entry (Day 1) or within 120 h after start of chemotherapy on Day 1 (Cohort 1 patients)
`or within 168 h (for Cohort 2 patients receiving the last IV NEPA on Day 3) or 216 h (for
`Cohort 2 patients receiving the last IV NEPA on Day 5) from start of chemotherapy on Day 1.
`3. Known history of allergy to any component of the study treatments or other
`contraindications to any NK1-RAs or 5-HT3-RAs.
`4. Active infection.
`5. Any illness or condition that, in the opinion of the Investigator, may pose unwarranted risks
`in administering the investigational product to the patient.
`6. Uncontrolled medical condition (e.g., uncontrolled insulin-dependent diabetes mellitus).
`7. Patient experiencing ongoing vomiting from any organic aetiology (including patients with
`history of gastric outlet obstruction or intestinal obstruction due to adhesions or volvulus),
`or patient with hydrocephalus.
`8. Patient who experienced any vomiting, retching, or nausea within 24 h prior to the
`administration of the study treatment on Day 1 (Note: functional vomiting for infants, which
`is normally seen during the first 3 months of life, is not to be considered as vomiting).
`9. Patient who received any drug with potential antiemetic effect within 24 h prior to
`administration of study treatment on Day 1, including but not limited to the following:
`NK1-RAs (e.g., (fos)aprepitant or any other drug of this class)
`5-HT3-RAs (e.g., ondansetron, granisetron, dolasetron, tropisetron, ramosetron)
`Benzamides (e.g., metoclopramide, alizapride)
`Phenothiazines (e.g., prochlorperazine, promethazine, perphenazine, fluphenazine,
`chlorpromazine, thiethylperazine)
`Benzodiazepines initiated 48 h prior to study treatment administration on Day 1 or
`expected to be administered within the efficacy assessment period, except for single
`doses of midazolam, temazepam, or triazolam
`Butyrophenones (e.g., droperidol, haloperidol)
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`Anticholinergics (e.g., scopolamine, except the inhaled anticholinergics for
`respiratory disorders e.g., ipratropium bromide)
`Antihistamines (e.g., diphenhydramine, cyclizine, hydroxyzine, chlorphenhyramine,
`dimenhydrinate, meclizine)
`Domperidone
`Mirtazapine
`Olanzapine
`Prescribed cannabinoids (e.g., tetrahydrocannabinol, nabilone)
`Over-the-counter (OTC) antiemetics, OTC cold medications, or OTC allergy
`medications
`Herbal preparations containing ephedra or ginger
`10. Patient who received palonosetron within 1 week prior to administration of study treatment
`on Day 1.
`11. Patient receiving systemic corticosteroid therapy above 0.14mg/kg or >10 mg of
`prednisone daily or equivalent.
`Exception:
`Dexamethasone for the prevention of CINV is permitted in association with the study
`treatment (Test Treatment and Reference Treatment) as per standard of care and
`applicable guidelines, provided its dosage is reduced by 50% in consideration of known
`interactions with various NK1 RAs, including fosaprepitant and fosnetupitant.
`12. Patient aged <6 years who received any investigational drug (defined as a medication with
`no marketing authorization granted for any age or indication) within 90 days prior to Day 1,
`or patient aged ≥6 years who received any investigational drug within 30 days prior to Day 1,
`or patient any age who is expected to receive investigational drugs prior to study
`completion.
`13. Intake of alcohol, food, or beverages (e.g., grapefruit, cranberry, pomegranate, and aloe vera
`juices; German chamomile) known to interfere with CYP3A4 or CYP2D6 metabolic enzymes
`within 1 week prior to Day 1 and during the overall study period.
`14. Use of any drugs or substances known to be strong inhibitors of CYP3A4 or CYP2D6
`enzymes within 1 week prior to Day 1 or planned to be used during the overall study period.
`15. Use of any drugs or substances known to be CYP3A4 substrates with narrow therapeutic
`range within 1 week prior to Day 1 or planned to be used during the overall study period.
`16. Use of any drugs or substances known to be strong inducers of CYP3A4 or CYP2D6
`enzymes within 4 weeks prior to Day 1 or planned to be used during the overall study
`period.
`17. Lactating female patient.
`18. Enrolment in a previous study on netupitant (either administered alone or in combination
`with palonosetron).
`19. Marked baseline prolongation of QTc interval (QTcF>460 millisecond [msec]). At the
`discretion of the investigator, criterion may be based on automatic interpretation of results.
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`Ages Eligible for Study
`0 Months to 18 Years (Child,  Adult)
`Sexes Eligible for Study
`All
`Accepts Healthy Volunteers
`No
`Study Plan
`This section provides details of the study plan, including how the study is designed and what the study
`is measuring.
`How is the study designed?
`Design Details
`Primary Purpose : Prevention
`Allocation : Randomized
`Interventional Model : Parallel Assignment
`Interventional Model Description:
`Cohort 1: Single-day HEC and single-dose administration of Test Treatment (IV
`NEPA) or administration of Reference Treatment (IV fosaprepitant + IV ondansetron)
`on Day 1. Due to fosaprepitant and ondansetron not being indicated in patients
`younger than 6 months of age and due to fosaprepitant not being indicated in
`patients with body weight <6 kg, in Cohort 1, patients aged <6 months will exclusively
`receive the Test Treatment. Patients aged ≥6 months and weighing at least 6 kg will
`be randomly allocated to either Test Treatment or Reference Treatment.
`Cohort 2: Multi-day HEC and repeated-dose administration of Test Treatment (IV
`NEPA), with the first administration on Day 1. All patients will receive the Test
`Treatment
`Masking : None (Open Label)
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`Arms and Interventions
`Participant Group/ArmIntervention/Treatment
`Experimental: IV NEPA
`The Test Treatment (IV
`NEPA) is planned to be
`administered in Cohort
`1 and Cohort 2.
`IV NEPA Dosing
`Schedule
`Cohort 1 (single-
`day HEC): Single
`30-min infusion on
`Day 1, before start
`of chemotherapy.
`Cohort 2 (multi-
`day HEC): Single
`30-min infusion on
`Days 1, 3, and 5
`(administration on
`Day 5 depending
`on the patient's
`multi day HEC
`scheme), before
`start of
`chemotherapy or
`in the morning if
`no chemotherapy
`is administered on
`the same day.
`Drug: IV NEPA (fosnetupitant/palonosetron)
`In NEPA-22-01, different body weight-based
`dosages of IV NEPA will be applied to
`patients below and over 3 months of age:
`Formulation A (for patients ≥3 months of age;
`235 mg fosnetupitant/1.5 mg palonosetron
`per vial) or Formulation B (for patients <3
`months of age; 235 mg fosnetupitant/2.5 mg
`palonosetron per vial).
`Active Comparator:
`Reference Treatment
`Drug: Reference Treatment: IV ondansetron
`infusion
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`What is the study measuring?
`Primary Outcome Measures
`The Reference
`Treatment is planned to
`be administered in
`Cohort 1 only. The
`Reference Treatment
`includes fosaprepitant
`powder for solution for
`IV infusion and
`ondansetron liquid
`solution for IV infusion.
`IV Ondansetron Dosing Regimen
`Day 1 (before start of chemotherapy):
`One 30-min infusion of 0.15 mg/kg
`(ondansetron maximum dose: 8 mg per
`administration)
`Day 1 at 4 h and 8 h after the end of first
`administration: Two 30-min infusions of
`0.15 mg/kg (ondansetron maximum
`dose: 8 mg per administration)
`Drug: Reference Treatment: IV fosaprepitant
`infusion
`Fosaprepitant IV Dosing Regimen
`Patients aged 12 years to <18 years: a
`single dose of IV fosaprepitant 150 mg
`Patients aged 2 years to <12 years: a
`single dose of IV fosaprepitant 4 mg/kg
`(maximum dose: 150 mg)
`Patients aged 6 months to <2 years: a
`single dose of IV fosaprepitant 5 mg/kg
`(maximum dose: 150 mg)
`Outcome
`Measure Measure Description Time
`Frame
`COHORT 1
`Neptupitant
`exposure
`parameter
`Maximum concentration (Cmax)From
`time
`zero (
`start of
`IV
`NEPA
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`Secondary Outcome Measures
`infusion
`) to
`maximu
`m 168
`hours
`COHORT 1
`Neptupitant
`exposure
`Area under the plasma concentration-time
`curve
`From
`time
`zero (
`start of
`IV
`NEPA
`infusion
`) to
`maximu
`m 168
`hours
`COHORT 2
`monitoring of
`AEs (safety and
`tolerability of IV
`NEPA)
`monitoring of AEs following repeated IV NEPA
`administration
`Up to
`31 days
`Outcome
`Measure Measure Description Time
`Frame
`COHORT 1: To
`assess the PK
`profile of
`netupitant.
`Cmax of netupitant From
`Time
`zero (
`start of
`IV
`NEPA
`infusion
`) until
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`168
`hours
`COHORT 1: To
`assess the PK
`profile of
`fosnetupitant.
`Cmax of fosnetupitant From
`Time
`zero (
`start of
`IV
`NEPA
`infusion
`) until
`168
`hours
`COHORT 1: To
`assess the PK
`profile
`palonosetron.
`Cmax of palonosetron From
`Time
`zero (
`start of
`IV
`NEPA
`infusion
`) until
`168
`hours
`COHORT 1: To
`assess the PK
`profile of
`netupitant
`AUC0-48 of netupitant From
`Time
`zero (
`start of
`IV
`NEPA
`infusion
`) until
`48
`hours
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`COHORT 1: To
`assess the PK
`profile of
`fosnetupitant.
`AUC0-48 of fosnetupitantFrom
`Time
`zero (
`start of
`IV
`NEPA
`infusion
`) until
`48
`hours
`COHORT 1: To
`assess the PK
`profile
`palonosetron.
`AUC0-48 of palonosetronFrom
`Time
`zero (
`start of
`IV
`NEPA
`infusion
`) until
`48
`hours
`COHORT 1: To
`assess the PK
`profile of
`netupitant
`t1/2 of netupitant From
`Time
`zero (
`start of
`IV
`NEPA
`infusion
`) until
`168
`hours
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`COHORT 1: To
`assess the PK
`profile of
`palonosetron.
`t1/2 of palonosetron From
`Time
`zero (
`start of
`IV
`NEPA
`infusion
`) until
`168
`hours
`COHORT 1 and
`2: To assess
`the population
`PK profile of
`fosnetupitant.
`Clearance (CL) of fosnetupitantFrom
`Time
`zero (
`start of
`IV
`NEPA
`infusion
`) until
`168
`hours
`COHORT 1 and
`2: To assess
`the population
`PK profile of
`palonosetron.
`CL of palonosetron From
`Time
`zero (
`start of
`IV
`NEPA
`infusion
`) until
`168
`hours
`COHORT 1 and
`2: To assess
`the population
`CL/F of netupitant From
`Time
`zero (
`start of
`8/3/25, 4:09 PM Study Details | Study With IV NEPA (Fosnetupitant/Palonosetron) for the Prevention of Chemotherapy-induced Nausea and Vomiting…
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`PK profile of
`netupitant.
`IV
`NEPA
`infusion
`) until
`168
`hours
`COHORT 1 and
`2: To assess
`the population
`PK profile of
`fosnetupitant
`Volume of compartments (V) for fosnetupitantFrom
`Time
`zero (
`start of
`IV
`NEPA
`infusion
`) until
`168
`hours
`COHORT 1 and
`2: To assess
`the population
`PK profile of
`palonosetron.
`V for palonosetron From
`Time
`zero (
`start of
`IV
`NEPA
`infusion
`) until
`168
`hours
`COHORT 1 and
`2: To assess
`the population
`PK profile of
`netupitant.
`V/F for netupitant From
`Time
`zero (
`start of
`IV
`NEPA
`infusion
`) until
`8/3/25, 4:09 PM Study Details | Study With IV NEPA (Fosnetupitant/Palonosetron) for the Prevention of Chemotherapy-induced Nausea and Vomiting…
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`Collaborators and Investigators
`This is where you will find people and organizations involved with this study.
`Helsinn Healthcare SA
`Study Record Dates
`These dates track the progress of study record and summary results submissions to ClinicalTrials.gov.
`Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure
`they meet specific quality control standards before being posted on the public website.
`Study Registration Dates
`First Submitted
`2024-12-16
`First Submitted that Met QC Criteria
`2025-03-31
`First Posted
`2025-04-01
`168
`hours
`Sponsor
`8/3/25, 4:09 PM Study Details | Study With IV NEPA (Fosnetupitant/Palonosetron) for the Prevention of Chemotherapy-induced Nausea and Vomiting…
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`Study Record Updates
`Last Update Submitted that met QC Criteria
`2025-07-23
`Last Update Posted
`2025-07-28
`Last Verified
`2025-07
`More Information
`Terms related to this study
`HHS Vulnerability Disclosure
`Keywords Provided by Helsinn Healthcare SA
`Prevention of chemotherapy-induced nausea and vomiting
`highly emetogenic chemotherapy
`HEC
`IV NEPA
`CINV
`Additional Relevant MeSH Terms
`Signs and Symptoms, Digestive
`Nausea
`Vomiting
`Antiemetics
`Autonomic Agents
`Peripheral Nervous System Agents
`Physiological Effects of Drugs
`Gastrointestinal Agents
`Antipruritics
`Dermatologic Agents
`Serotonin 5-HT3 Receptor Antagonists
`Serotonin Antagonists
`Serotonin Agents
`Neurotransmitter Agents
`Molecular Mechanisms of Pharmacological Action
`8/3/25, 4:09 PM Study Details | Study With IV NEPA (Fosnetupitant/Palonosetron) for the Prevention of Chemotherapy-induced Nausea and Vomiting…
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`Plan for Individual Participant Data (IPD)
`Drug and device information, study documents, and helpful links
`Neurokinin-1 Receptor Antagonists
`Ondansetron
`Palonosetron
`Fosaprepitant
`Aprepitant
`Plan to Share Individual Participant Data (IPD)?
`No
`IPD Plan Description
`Only global trial data will be shared, not a single patient
`Studies a U.S. FDA-Regulated Drug Product
`Yes
`Studies a U.S. FDA-Regulated Device Product
`No
`8/3/25, 4:09 PM Study Details | Study With IV NEPA (Fosnetupitant/Palonosetron) for the Prevention of Chemotherapy-induced Nausea and Vomiting…
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