8/3/25, 4:10 PM Study Details | A Safety Study of Intravenous Pro-Netupitant and Palonosetron Combination for the Prevention of Nausea and Vomiti...
`
`ClinicalTrials.gov m National Library of Medicine
`
`National Center for Biotechnology Information
`
`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.
`
`Completed i
`
`A Safety Study of Intravenous Pro-Netupitant and Palonosetron Combination
`for the Prevention of Nausea and Vomiting
`
`ClinicalTrials.gov ID @ nNcT02517021
`Sponsor © Helsinn Healthcare SA
`
`Information provided by @ Helsinn Healthcare SA (Responsible Party)
`
`Last Update Posted @ 2018-06-20
`
`Study Details Tab
`
`Study Overview
`
`Brief Summary
`
`NEPA-15-18 is a clinical study assessing safety of pro-netupitant and palonosetron, two antiemetic
`drugs, given with oral dexamethasone. The objective of the study is to evaluate if pro-netupitant and
`palonosetron are safe when administered to prevent nausea and vomiting after administration of
`repeated cycles of chemotherapy.
`
`Official Title
`
`X
`
`2
`A Phase 3, Multicenter, Randomized, Double-blind, Active Control Study to Evaluate the Safety and L
`
`@
`Efficacy of IV Pro-netupitant/Palonosetron (260 mg/0.25 mg) Combination for the Prevention of 4
`Chemotherapy-induced Nausea and Vomiting in Repeated Chemotherapy Cycles in Patients Receiving m
`Highly Emetogenic Chemotherapy
`Conditions @
`
`https://clinicaltrials.gov/study/NCT02517021 119
`HELSINN EXHIBIT 2031
`
`Azurity Pharmaceuticals, Inc. v. Helsinn Healthcare S.A.
`
`Page 1 of 19 IPR2025-00948
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`8/3/25, 4:10 PM Study Details | A Safety Study of Intravenous Pro-Netupitant and Palonosetron Combination for the Prevention of Nausea and Vomiti...
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`Chemotherapy-Induced Nausea and Vomiting
`
`Intervention / Treatment @
`
`o Drug: Pro-netupitant/Palonosetron
`o Drug: Netupitant/Palonosetron
`o Drug: Dexamethasone
`
`Other Study ID Numbers @
`
`Study Start @
`
`2015-11
`
`Primary Completion (Actual) @
`
`2016-08
`
`Study Completion (Actual) @
`
`2016-08
`
`Enrollment (Actual) @
`
`405
`
`Study Type @
`
`Interventional
`
`Phase @
`
`Phase 3
`
`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.nim.nih.gov/dailymed/) available for:
`
`Dexamethasone (https://dailymed.nlm.nih.gov/dailymed/search.cfm?
`labeltype=human&query=Dexamethasone)
`
`Palonosetron (https://dailymed.nlm.nih.gov/dailymed/search.cfm?
`
`labeltype=human&gquery=Palonosetron)
`
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`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).
`
`This study has 74 locations
`
`United States
`
`California Locations
`
`Santa Monica, California, United States,
`90403-480
`
`Sarcoma Oncology Center
`Whittier, California, United States, 90603
`The Oncology Institute of Hope and Innovation
`Colorado Locations
`
`Grand Junction, Colorado, United States,
`81501
`St. Mary's Medical Center
`
`Florida Locations
`Miami, Florida, United States, 33143
`Well Pharma Medical Research Corporation
`lllinois Locations
`Peoria, lllinois, United States, 61615-7822
`lllinois CancerCare
`Indiana Locations
`Bloomington, Indiana, United States, 47403
`
`Indiana University Health Bloomington
`
`Louisiana Locations
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`Alexandria, Louisiana, United States, 71301
`Christus St. Frances Cabrini Hospital
`
`New York Locations
`
`East Setauket, New York, United States, 11733
`North Shore Hematology Oncology Associates
`PC
`
`Ohio Locations
`
`Canton, Ohio, United States, 44718
`
`Gabrail Cancer Center Research
`
`Tennessee Locations
`
`Germantown, Tennessee, United States,
`38138
`West Cancer Center
`
`Knoxville, Tennessee, United States, 37909
`Provision Center for Biomedical Research
`
`Austria
`
`Graz, Austria, 8036
`University Hospital Graz, Department of Internal
`Medicine
`
`Krems, Austria
`Krems Country Hospital
`
`Linz, Austria, 4020
`Hospital Elisabethinen Linz GmbH, Internal
`Department #1 - Hemato-Oncology
`
`Linz, Austria, 4021
`General Hospital Linz GmbH, Internal Medicine
`Department #3 - Center for Hematology and
`Medical Oncology
`
`St. Poelten, Austria
`University Hospital St. Poelten,1st Medical
`Department
`
`Croatia
`
`Osijek, Croatia
`Clinical Hospital Centre Osijek
`
`Varazdin, Croatia
`General Hospital Varazdin
`
`Zagreb, Croatia
`Clinical Hospital Center "Sestre milosrdnice"
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`Study Details | A Safety Study of Intravenous Pro-Netupitant and Palonosetron Combination for the Prevention of Nausea and Vomiti...
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`Zagreb, Croatia
`
`University Hospital Centre Zagreb "Jordanovac"
`
`Czechia
`
`Brno, Czechia
`University Hospital Brno. Clinic of Pulmonary
`
`Diseases and Tuberculosis
`
`Brno, Czechia
`University Hospital
`
`Novy Jicin, Czechia
`Hospital Novy Jicin, Department of Oncology
`
`Prague, Czechia, 140 59
`Thomayer's Hospital, Clinic of Pneumology
`
`Prague, Czechia
`Hospital Na Bulovce
`
`Usti nad Labem, Czechia
`Masaryk's Hospital Usti nad Labem, Oncology
`Dept
`
`Germany
`
`Israel
`
`Bielefeld, Germany
`Onkoligische Schwerpunktpraxis Bielefeld
`
`Hamburg, Germany
`OncoResearch Lerchenfeld GmbH
`
`Hannover, Germany
`Hannover Medical School
`
`Leipzig, Germany
`Universitaetsklinikum Leipzig; Universitaeres
`Krebszentrum (UCCL)
`
`Miinchen, Germany
`Staedtisches Klinikum Muenchen GmbH;
`Klinikum N euperlach
`
`Ashkelon, Israel
`Barziali Medical Center, Oncology Unit
`
`Beer Sheva, Israel
`Soroka University Medical Center,Oncology
`division
`
`Haifa, Israel
`
`Rambam Health Care Campus
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`Italy
`Avellino, Italy
`S. G. Moscati Hospital, Medical Oncology
`Division
`Meldola, Italy
`cientific Institute of Romagna for the Study and
`Treatment of Cancer (IRST), IRCCS
`Milan, Italy
`National Cancer Institute, IRCCS, Medical
`Oncology Department
`Monza, Italy
`Azienda Socio Sanitaria Territoriale-Monza
`(ASST-Monza) - Oncology Department
`Potenza, Italy
`Regional Hospital "San Carlo"
`Vimercate, Italy
`Local Healthcare Company of Vimercate (ASST
`Vimercate)
`Poland
`Gdynia, Poland
`Provincial Hospitals in Gdynia Sp. z 0.0. (LLC)
`Poznan, Poland, 60-569
`Lord's Transfiguration Teaching Hospital,
`Department of Chemotherapy
`Prabuty, Poland, 82-550
`Specialist Hospital in Prabuty Sp. z 0 .0. (LLC),
`Department of Pulmonology
`Tarnobrzeg, Poland
`Zofia Zamoyska nee Tarnowska Provincial
`Hospital in Tarnobrzeg
`Torun, Poland
`Ludwik Rydygier Provincial Hospital
`Warsaw, Poland, 02-781
`Maria Sklodowska-Curie Institute of Oncology,
`Department of Lung and Thoracic Cancers
`Warsaw, Poland, 03-291
`MAGODENT Sp. z 0 .0. (LLC), Branch No. 4,
`Department of Clinical Oncology/Chemotherapy
`Serbia
`Belgrade, Serbia
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`Clinical Center of Serbia, Clinic of Pulmonology
`
`Belgrade, Serbia
`Clinical Hospital Center Bezanijska Kosa, Clinic
`of Oncology
`
`Belgrade, Serbia
`Institute of Oncology and Radiology of Serbia,
`Clinic of Medical Oncology
`
`Belgrade, Serbia
`Military Medical Academy
`
`Sremska Kamenica, Serbia
`Institute of Pulmonary Diseases of Vojvodina,
`
`Pulmonary Oncology Clinic
`
`Sremska Kamenica, Serbia
`Oncology Institute of Vojvodina
`
`South Africa
`
`George, South Africa
`GVI Outeniqua Oncology Unit
`
`Johannesburg, South Africa
`Medical Oncology Centre of Rosebank
`
`Spain
`
`Avila, Spain, 05004
`Our Lady of Sonsoles Hospital
`
`Madrid, Spain, 28035
`Hospital Puerta de Hierro
`
`Madrid, Spain
`Hospital La Paz, Oncology Department
`
`Madrid, Spain
`University Hospital Quiron Madrid, Department
`of Oncology
`Andalucia Locations
`Sevilla, Andalucia, Spain
`
`Hospital Nuestra Senora de Valme
`
`Ukraine
`
`Chernivtsi, Ukraine, 58013
`Chernivtsi Regional Clinical Oncology Center,
`Day Care Unit
`
`Dnipropetrovsk, Ukraine, 49055
`Clinical Oncology Center, Department of
`Chemotherapy
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`Dnipropetrovsk, Ukraine, 49102
`Dnipropetrovsk City Multispecialty Clinical
`Hospital #4, Department of Chemotherapy
`
`Ivano-Frankivsk, Ukraine, 76000
`Regional Clinical Oncology Center,
`Chemotherapy Department
`
`Kharkiv, Ukraine, 61024
`S.P. Hryhoriev Institute of Medical Radiology,
`Department of Chemotherapy
`
`Kharkiv, Ukraine, 61070
`Kharkiv Regional Clinical Oncology Center,
`
`Chemotherapy Department #1
`
`Khmelnytskyi, Ukraine, 29009
`Khmelnytskyi Regional Oncology Center, Surgery
`Department #1
`
`Kryvyi Rih, Ukraine, 50048
`Kryvyi Rih Oncology Center, Department of
`Chemotherapy
`
`Lviv, Ukraine, 79031
`Lviv State Regional Treatment and Diagnostics
`Oncology Center, Department of Chemotherapy
`
`Ternopil, Ukraine, 46023
`Ternopil Regional Public Clinical Oncology
`Center
`
`Uzhhorod, Ukraine, 88000
`LTD UNIMED Adjara
`
`Uzhhorod, Ukraine, 88014
`Zakarpattia Regional Clinical Oncology Center,
`Department of Chemotherapy
`
`Vinnytsia, Ukraine, 21029
`Vinnytsia Regional Clinical Oncology Center,
`Department of Chemotherapy
`
`Zaporizhia, Ukraine, 69040
`Zaporizhia Regional Clinical Oncology Center,
`
`Thoracic Department
`
`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.
`
`https://clinicaltrials.gov/study/NCT02517021 8/19
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`8/3/25, 4:10 PM Study Details | A Safety Study of Intravenous Pro-Netupitant and Palonosetron Combination for the Prevention of Nausea and Vomiti...
`For general information about clinical research, read Learn About
`Studies (https://clinicaltrials.gov/study-basics/learn-about-studies).
`
`https://clinicaltrials.gov/study/NCT02517021 9/19
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`Page 9 of 19
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`Study Details | A Safety Study of Intravenous Pro-Netupitant and Palonosetron Combination for the Prevention of Nausea and Vomiti...
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`Eligibility Criteria
`
`Description
`
`Inclusion Criteria:
`
`Cycle 1
`
`Signed written informed consent
`
`Histologically or cytologically confirmed solid tumor malignancy.
`
`Naive to cytotoxic chemotherapy. Previous biological or hormonal therapy will be permitted.
`Scheduled to receive at least 4 repeated consecutive cycles of the following highly
`emetogenic reference chemotherapies (HEC), alone or in combination with other
`chemotherapeutic agents on Day 1: cisplatin administered as a single IV dose of =70
`mg/m2; cyclophosphamide >1500 mg/m2; carmustine (BCNU) >250mg/m2; dacarbazine
`(DTIC); mechloretamine (nitrogen mustard)
`
`Eastern Cooperative Oncology Group (ECOG) Performance Status of 0,1, 0r 2 .
`
`If a patient is female, she shall be of non-childbearing potential or of childbearing potential
`using reliable contraceptive measures and having a negative urine pregnancy test.
`Hematologic and metabolic status adequate for receiving an highly emetogenic regimen
`based on laboratory criteria (Total Neutrophils,Platelets, Bilirubin, Liver enzymes, Serum
`Creatinine or Creatinine Clearance)
`
`Able to read, understand, follow the study procedure and complete patient diary.
`
`Cycles 2 to 4:
`
`The following inclusion criteria must be checked prior to inclusion at each repeated cycle:
`
`Participation in the study during the next cycle of chemotherapy is considered appropriate
`by the Investigator and does not pose unwarranted risk to the patient.
`
`Scheduled to receive the same chemotherapy regimen as Cycle 1 or one of the reference
`chemotherapies as defined in Inclusion criterion 5 for Cycle 1.
`
`If a patient is female, she shall be of non--childbearing potential or of childbearing potential
`using reliable contraceptive measures and having a negative urine pregnancy test.
`Adequate hematologic and metabolic status according to the Investigator's opinion.
`
`Exclusion Criteria:
`
`Cycle 1
`
`Lactating woman.
`
`Active infection or uncontrolled disease except for malignancy that may pose unwarranted
`risks in administering the study drugs to the patient.
`
`Current use of illicit drugs or current evidence of alcohol abuse.
`
`Scheduled to receive moderately or highly emetogenic chemotherapies from Day 2 to Day 5.
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`Study Details | A Safety Study of Intravenous Pro-Netupitant and Palonosetron Combination for the Prevention of Nausea and Vomiti...
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`Received or is scheduled to receive radiation therapy to the abdomen or the pelvis within 1
`week prior to the start of the reference chemotherapy administration on Day 1 or between
`Days 110 5.
`
`Any vomiting, retching, or nausea (grade = 1 as defined by National Cancer Institute) within
`24 hours prior to the start of the reference chemotherapy administration on Day 1.
`Symptomatic primary or metastatic CNS malignancy.
`
`Known hypersensitivity or contraindication to 5-HT3 receptor antagonists, to
`dexamethasone or to NK-1 receptor antagonists.
`
`Known contraindication to the IV administration of 50 mL 5% glucose solution.
`
`Previously received an NK-1 receptor antagonist.
`
`Participation in a previous clinical trial involving IV pro-netupitant or oral netupitant
`administered alone or in combination with palonosetron.
`
`Any investigational drugs (other than those given in this study) taken within 4 weeks prior to
`Day 1, and/or is scheduled to receive any investigational drug during the present study.
`Systemic corticosteroid therapy at any dose within 72 hours prior to the start of reference
`chemotherapy administration on Day 1. Topical and inhaled corticosteroids are permitted.
`Scheduled to receive bone marrow transplantation and/or stem cell rescue therapy.
`Scheduled to receive any strong or moderate inhibitor of CYP3A4 or its intake within 1T week
`prior to Day 1.
`
`Scheduled to receive any of the following CYP3A4 substrates within 1 week prior to Day 1:
`terfenadine, cisapride, astemizole, pimozide.
`
`Received within 4 weeks prior to Day 1 or scheduled to receive any CYP3A4 inducer.
`
`Any medication with known or potential antiemetic activity within 24 hours prior to the start
`of reference chemotherapy administration on Day 1 of Cycle 1, including but not limited to
`5-HT3 receptor antagonists and NK-1 receptor antagonists
`
`History or predisposition to cardiac conduction abnormalities, except for incomplete right
`bundle branch block
`
`History of Torsade de Point or known history of risk factors for Torsade de Point (heart
`failure, hypokalemia, family history of Long QT Syndrome).
`
`Severe cardiovascular diseases diagnosed within 3 months prior to Day 1 of first cycle,
`including myocardial infarction, unstable angina pectoris, significant valvular or pericardial
`disease, history of ventricular tachycardia, symptomatic Congestive Heart Failure (CHF)
`New York Heart Association (NYHA) class IlI-1V, and severe uncontrolled arterial
`hypertension.
`
`Any illness or condition that, in the opinion of the Investigator, may confound the results of
`the study or pose unwarranted risks in administering the investigational product to the
`patient.
`
`Concurrent medical condition that would preclude administration of dexamethasone such
`as systemic fungal infection or uncontrolled diabetes.
`
`Cycles 2to 4:
`
`The following exclusion criteria must be checked prior to inclusion in each repeated cycle:
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`e Lactating woman.
`
`« Active infection or uncontrolled disease except for malignancy that may pose unwarranted
`risks in administering the study drugs to the patient.
`
`« Started any of the restricted medications.
`
`» Any vomiting, retching, or nausea (grade = 1 as defined by National Cancer Institute) within
`24 hours prior to the start of reference chemotherapy administration on Day 1.
`
`« Received or is scheduled to receive radiation therapy to the abdomen or the pelvis within 1
`week prior to the start of the reference chemotherapy administration on Day 1 or between
`Days 110 5.
`
`o Symptomatic primary or metastatic CNS malignancy.
`
`Ages Eligible for Study @
`
`18 Years and older (Adult, Older 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
`
`Masking @ : Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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`What is the study measuring?
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`Study Details | A Safety Study of Intravenous Pro-Netupitant and Palonosetron Combination for the Prevention of Nausea and Vomiti...
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`Arms and Interventions
`
`Participant Group/Arm
`o
`
`Experimental: Pro-
`netupitant/Palonosetron
`plus Dexamethasone
`
`Intravenous Pro-
`netupitant/Palonosetron
`(260 mg/0.25 mg)
`powder for solution for
`infusion (on Day 1) with
`oral dexamethasone
`prior to each scheduled
`chemotherapy cycle
`
`Active Comparator:
`Netupitant/Palonosetron
`plus Dexamethasone
`
`Oral
`netupitant/palonosetron
`(300 mg/0.50 mg) hard
`capsule (on Day 1) with
`oral dexamethasone
`prior to each scheduled
`chemotherapy cycle
`
`Intervention/Treatment @
`
`Drug: Pro-netupitant/Palonosetron
`e Other Names:
`o |V NEPA FDC
`Drug: Dexamethasone
`
`Drug: Netupitant/Palonosetron
`e Other Names:
`o QOral NEPA FDC
`Drug: Dexamethasone
`
`Primary Outcome Measures o
`
`Outcome
`
`Measure Description
`
`Measure
`
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`Time
`Frame
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`Percentage of
`Patients With
`Adverse Events
`
`This is a safety study where Adverse Events is
`the primary outcome (defined by the current
`ICH Guideline for Good Clinical Practice).
`Patients are randomized according to a 1:1
`ratio (IV NEPA FDC : oral NEPA FDC). No formal
`comparison is planned, the presence of a
`control in the same patient population helps
`interpret any unexpected safety finding in the
`experimental arm. It is expected that the
`number of patients randomized to the test
`group, i.e., 200, will allow approximately 100
`patients to be treated with the test drug for 4
`cycles. Based on 100 patients treated at Cycle
`4 with the IV NEPA FDC, if a given Adverse
`Event (AE) is not observed, an AE incidence of
`3% or greater can be excluded with 95%
`confidence.
`
`Secondary Outcome Measures o
`
`Outcome
`Measure
`
`Percentage of
`Patients With
`Complete
`Response (CR)
`
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`Measure Description
`
`Particip
`ants
`will be
`followe
`d for
`the
`duratio
`n of the
`chemot
`herapy,
`an
`expecte
`d
`average
`duratio
`n of up
`to 14
`weeks
`assumi
`nga
`maximu
`m of 4
`chemot
`herapy
`cycles
`given
`every 3
`weeks.
`
`Time
`Frame
`
`0-24
`hours
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`Defined as no
`Emesis, no
`Rescue
`Medication, in
`the Acute
`Phase
`
`Percentage of
`Patients With
`Complete
`Response (CR)
`Defined as no
`Emesis, no
`Rescue
`Medication, in
`the Delayed
`Phase
`
`Percentage of
`Patients With
`Complete
`Response (CR)
`Defined as no
`Emesis, no
`Rescue
`Medication, in
`the Overall
`Phase
`
`Percentage of
`Patients With
`no Emetic
`Episodes in the
`Acute Phase
`
`Percentage of
`Patients With
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`>24-120
`hours
`
`0-120
`hours
`
`0-24
`hours
`
`>24-120
`hours
`
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`no Emetic
`Episodes in the
`Delayed Phase
`
`Percentage of
`Patients With
`no Emetic
`Episodes in the
`Overall Phase
`
`Percentage of
`Patients With
`no Significant
`Nausea (VAS
`<25 mm)
`During the
`Acute Phase
`
`Percentage of
`Patients With
`no Significant
`Nausea (VAS
`<25 mm)
`During the
`Delayed Phase
`
`Percentage of
`Patients With
`no Significant
`Nausea (VAS
`<25 mm)
`During the
`Overall Phase
`
`https://clinicaltrials.gov/study/NCT02517021
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`Page 16 of 19
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`0-120
`hours
`
`0-24
`hours
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`>24-120
`hours
`
`0-120
`hours
`
`16/19
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`
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`8/3/25, 4:10 PM Study Details | A Safety Study of Intravenous Pro-Netupitant and Palonosetron Combination for the Prevention of Nausea and Vomiti...
`
`Collaborators and Investigators
`This is where you will find people and organizations involved with this study.
`
`Sponsor @
`
`Helsinn Healthcare SA
`
`Collaborators @
`
`e PSICRO
`
`Publications
`From PubMed
`These publications come from PubMed, a public database of scientific and medical articles. This list is
`
`automatically created by ClinicalTrials.gov Identifier (NCT Number), and these articles may or may not
`be about the study.
`
`» Schwartzberg L, Roeland E, Andric Z, Kowalski D, Radic J, Voisin D, Rizzi G, Navari R, Gralla RJ,
`Karthaus M. Phase Il safety study of intravenous NEPA: a novel fixed antiemetic combination of
`
`fosnetupitant and palonosetron in patients receiving highly emetogenic chemotherapy. Ann
`Oncol. 2018 Jul 1;29(7):1535-1540. doi: 10.1093/annonc/mdy169.
`(https://pubmed.ncbi.nlm.nih.gov/29722791),
`
`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 @
`2015-08-03
`
`First Submitted that Met QC Criteria @
`2015-08-05
`
`First Posted (Estimated) @
`
`https://clinicaltrials.gov/study/NCT02517021 1719
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`Page 17 of 19
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`8/3/25, 4:10 PM Study Details | A Safety Study of Intravenous Pro-Netupitant and Palonosetron Combination for the Prevention of Nausea and Vomiti...
`2015-08-06
`
`Results Reporting Dates
`
`Results First Submitted @
`2018-05-09
`
`Results First Submitted that Met QC Criteria @
`2018-06-18
`
`Results First Posted @
`2018-06-20
`
`HHS Vulnerability Disclosure
`
`Certification/Extension Dates
`
`Certification/Extension First Submitted @
`
`2016-09-07
`
`Certification/Extension First Submitted that Met QC Criteria @
`2016-09-07
`
`Certification/Extension First Posted (Estimated) @
`
`2016-09-08
`
`Study Record Updates
`
`Last Update Submitted that met QC Criteria @
`2018-06-18
`
`Last Update Posted @
`2018-06-20
`
`Last Verified @
`2018-06
`
`More Information
`
`Terms related to this study
`
`Additional Relevant MeSH Terms
`
`Signs and Symptoms, Digestive
`
`https://clinicaltrials.gov/study/NCT02517021 18/19
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`Page 18 of 19
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`8/3/25, 4:10 PM Study Details | A Safety Study of Intravenous Pro-Netupitant and Palonosetron Combination for the Prevention of Nausea and Vomiti...
`Nausea
`Vomiting
`Anti-Inflammatory Agents
`Antiemetics
`Autonomic Agents
`Peripheral Nervous System Agents
`Physiological Effects of Drugs
`Gastrointestinal Agents
`Glucocorticoids
`Hormones
`Hormones, Hormone Substitutes, and Hormone Antagonists
`Antineoplastic Agents, Hormonal
`Antineoplastic Agents
`Serotonin 5-HT3 Receptor Antagonists
`Serotonin Antagonists
`Serotonin Agents
`Neurotransmitter Agents
`Molecular Mechanisms of Pharmacological Action
`Dexamethasone
`Palonosetron
`
`https://clinicaltrials.gov/study/NCT02517021 19/19
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`Page 19 of 19
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