8/3/25, 3:12 PM Study Details | A Safety Study of Oral Netupitant and Palonosetron for the Prevention of Nausea and Vomiting | ClinicalTrials.gov
`
`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 Oral Netupitant and Palonosetron for the Prevention of
`
`Nausea and Vomiting
`
`ClinicalTrials.gov ID © NCT01376297
`
`Sponsor © Helsinn Healthcare SA
`
`Information provided by @ Helsinn Healthcare SA (Responsible Party)
`
`Last Update Posted Q 20141117
`
`Study Details Tab
`Study Overview
`Brief Summary
`NETU-10-29 is a clinical study assessing safety of netupitant and palonosetron, two antiemetic drugs,
`both given with oral dexamethasone. The objective of the study is to evaluate if 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 lll, Multicenter, Randomized, Double-blind, Unbalanced (3:1) Active Control Study to Assess the %
`Safety and Describe the Efficacy of Netupitant and Palonosetron for the Prevention of Chemotherapy- 4
`induced Nausea and Vomiting in Repeated Chemotherapy Cycles. m
`
`Conditions @
`
`https://clinicaltrials.gov/study/NCT01376297 117
`
`HELSINN EXHIBIT 2018
`Azurity Pharmaceuticals, Inc. v. Helsinn Healthcare S.A.
`
`Page 1 of 17 IPR2025-00945
`
`
`
`
`
`
`
`
`8/3/25, 3:12 PM Study Details | A Safety Study of Oral Netupitant and Palonosetron for the Prevention of Nausea and Vomiting | ClinicalTrials.gov
`
`Chemotherapy-Induced Nausea and Vomiting
`
`Intervention / Treatment @
`
`Drug: Netupitant and Palonosetron
`e Drug: Aprepitant
`
`« Drug: Palonosetron
`
`o Drug: Dexamethasone
`
`Other Study ID Numbers @
`
`Study Start @
`
`2011-07
`
`Primary Completion (Actual) @
`
`2012-09
`
`Enrollment (Actual) @
`
`413
`
`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.nlm.nih.gov/dailymed/) available for:
`
`Dexamethasone (https:/dailymed.nlm.nih.gov/dailymed/search.cfm?
`
`labeltype=human&gquery=Dexamethasone),
`
`Palonosetron (https://dailymed.nlm.nih.gov/dailymed/search.cfm?
`
`labeltype=human&query=Palonosetron)
`
`Aprepitant (https://dailymed.nlm.nih.gov/dailymed/search.cfm?
`
`labeltype=human&query=Aprepitant)
`
`https://clinicaltrials.gov/study/NCT01376297
`
`Page 2 of 17
`
`2117
`
`
`
`
`
`
`
`
`8/3/25, 3:12 PM Study Details | A Safety Study of Oral Netupitant and Palonosetron for the Prevention of Nausea and Vomiting | ClinicalTrials.gov
`
`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 75 locations
`
`United States
`
`Alabama Locations
`
`Muscle Shoals,, Alabama, United States,
`35661
`
`Northwest Alabama Cancer Center PC
`
`California Locations
`
`Burbank, California, United States, 91505
`East Valley Hematology and Oncology Medical
`Group
`
`Los Angeles, California, United States, 90017
`American Institute of Research
`
`New Jersey Locations
`
`East Orange, New Jersey, United States,
`07018
`Veterans Administration New Jersey Health
`Care System
`
`New York Locations
`Nyack, New York, United States, 10960
`Hematology Oncology Associates of Rockland
`
`Ohio Locations
`
`Canton, Ohio, United States, 44708
`Hematology and Oncology Associates, Inc.
`
`https://clinicaltrials.gov/study/NCT01376297
`
`Page 3 of 17
`
`3/17
`
`
`
`
`
`
`
`
`8/3/25, 3:12 PM
`
`Massillon, Ohio, United States, 44646
`Tri-County Hematology & Oncology Associates,
`
`Inc
`
`Rhode Island Locations
`
`Pawtucket, Rhode Island, United States,
`02860
`Cancer Center at Memorial Hospital of RI
`
`South Carolina Locations
`
`Spartanburg, South Carolina, United States,
`29303
`Spartanburg Regional Health Services
`
`Texas Locations
`
`Corpus Christi, Texas, United States, 78405
`South Texas Comrehensive Cancer Centers
`
`Houston, Texas, United States, 77030-4009
`MD Anderson Cancer Center
`
`Bulgaria
`
`Pleven, Bulgaria, 5800
`UMHAT "Dr. Georgi Stranski"
`
`Shumen, Bulgaria, 9700
`Complex Oncology Center - Shumen Ltd.
`[Oncology]
`
`Tarnovo, Bulgaria, 5000
`COC - Veliko Tarnovo Dept. Medical Oncology
`
`Varna, Bulgaria, 9010
`Specialized Hospital for Active Treatment in
`
`Oncology "Dr. Marko Markov" Varna
`
`Vratsa, Bulgaria, 3000
`COC - Vratsa Dept. of Palliative Care
`
`Czech Republic
`
`Mlada Boleslav, Czech Republic, 293 50
`Oblastni nemocnice Mlada Boleslav a.s.,
`
`Onkologie
`
`Nymburk, Czech Republic, 288 01
`AVICENNUS s.r.0. Onkologie Nymburk
`
`Praha 5, Czech Republic, 150 06
`Fakultni nemocnice v Motole
`
`Praha 5, Czech Republic, 150 30
`
`https://clinicaltrials.gov/study/NCT01376297
`
`Page 4 of 17
`
`Study Details | A Safety Study of Oral Netupitant and Palonosetron for the Prevention of Nausea and Vomiting | ClinicalTrials.gov
`
`4117
`
`
`
`
`
`
`
`
`8/3/25, 3:12 PM
`
`Study Details | A Safety Study of Oral Netupitant and Palonosetron for the Prevention of Nausea and Vomiting | ClinicalTrials.gov
`
`Nemocnice Na Homolce, Oddeleni klinicke
`onkologie
`
`Znojmo, Czech Republic, 669 02
`Nemocnice Znojmo, p.o.
`
`Germany
`
`Augsburg, Germany, 86150
`Gemeinschaftspraxis, Dr. Med O.Brundler und
`B.Heinreich, PD Dr. med M.Bangerter Fachéarzte
`flir Innere Medizin, Hdmatologie und
`internistische Onkologie
`
`Berlin, Germany, 12200
`Charite - Campus Benjamin Franklin (CBF)
`
`Berlin, Germany, 13347
`Medizinisches Versorgungszentrum fiir
`Hamatologie und Tumorerkrankungen, HIV/AIDS
`und Hepatitiden
`
`Dresden, Germany, 01307
`
`Universitaetsklinikum Carl Gustav Carus
`
`Duisburg, Germany, 47166
`St. Johannes Hospital Medizinische Klinik II,
`Hamatologie, Onkologie und klinische
`
`Immunologie
`
`Freiburg, Germany, 79106
`Praxis Fuer Interdisziplinaere Onkologie und
`Haematologie
`
`Hannover, Germany, 30625
`Medizinische Hochschule, Zentrum fiir Innere
`Medizin, Klinik fir Hdmatologie,
`Hamostaseologie, Onkologie und
`Stammzelltransplantation
`
`Hennigsdorf, Germany, 16761
`Arzteforum Hennigsdorf
`
`Marburg, Germany, 35037
`Praxis fiir Innere Medizin, Hdmatologie und
`Internistische Onkologie
`
`Monchengladbach, Germany, 41062
`Krankenhaus, Maria Hilf, St. Franziskus Innere
`Medizin
`
`Regensburg, Germany, 93053
`OncoPRO GbR Dr. R. Dengler, Dr. A. Krober
`
`Hungary
`
`Budapest, Hungary, 1122
`
`https://clinicaltrials.gov/study/NCT01376297
`
`Page 5 of 17
`
`5/17
`
`
`
`
`
`
`
`
`8/3/25, 3:12 PM
`
`India
`
`Study Details | A Safety Study of Oral Netupitant and Palonosetron for the Prevention of Nausea and Vomiting | ClinicalTrials.gov
`
`Orszagos Onkoldgiai Intézet, B. Belgydgyaszati
`Osztély
`
`Gyula, Hungary, 5700
`Bekes Megyei Kepviselo-testulet Pandy Kalman
`Korhaz
`
`Kaposvar, Hungary, 7400
`Kaposi Mor Oktato Korhaz [Klinikai Onkologiai
`Centrum]
`
`Miskolc, Hungary, 3501
`Borsod-Abauj-Zemplén Megyei Kérhaz és
`Egyetemi Oktatdk
`
`Szentes, Hungary, 6600
`Dr. Bugyi Istvan Korhaz [Oncology]
`
`Székesfehérvar, Hungary, 8000
`Fejér Megyei Szent Gyorgy Korhaz [Onkoldgiai
`Osztaly]
`
`Poland
`
`Chennai, India, 600010
`Kumaran Hospital PVT Ltd
`
`Chennai, India, 600018
`Dr.Rai Memorial Medical centre
`
`Cuttack, India, 753007
`Acharya Harihara Regional Cancer Centre
`[Oncology]
`
`Gujarat, India, 388325
`M.S Patel Cancer Hospital [Oncology]
`
`Hubli, India, 580025
`Research Unit, The Karnatak cancer therapy &
`
`Research Instit
`
`Jaipur, India, 302016
`S.M.S College And Hospital
`
`Madurai, India, 625020
`Apollo Speciality Hospital [Oncology]
`
`Uttar Pradesh, India, 226001
`Lucknow Cancer Institute [Oncology]
`
`Visakhapatnam, India, 530002
`King George Hospital [Medical Oncology]
`
`Bialystok, Poland, 15-027
`Bialostockie Centrum Onkologii im.
`
`https://clinicaltrials.gov/study/NCT01376297
`
`Page 6 of 17
`
`6/17
`
`
`
`
`
`
`
`
`8/3/25, 3:12 PM
`
`Study Details | A Safety Study of Oral Netupitant and Palonosetron for the Prevention of Nausea and Vomiting | ClinicalTrials.gov
`
`M.Sklodowskiej-Curie im dr. E.Pileckiej z
`Pododdzialem Chemioterapii Dziennej
`
`Lublin, Poland, 20-090
`Centrum Onkologii Ziemi Lubelskiej im.Sw.Jana
`z Dukli Il Oddzial Onkologii Ginekologiczne;j,
`Radioterapii | Chemioterapii
`
`Poznan, Poland, 60-535
`Ginekologiczno-Potozniczy Szpital Kliniczny UM
`
`w Poznaniu
`
`Poznan, Poland, 60-569
`Szpital Kliniczny Przemienienia Panskiego UM w
`
`Poznaniu
`
`Poznan, Poland, 61-866
`Wielkopolskie Centrum Onkologii im. M.
`Sklodowskiej-Curie i Onkologii Ginekologicznej
`
`Prabuty, Poland, 82-550
`Szpital Specjalistyczny
`
`Raciborz, Poland, 47-400
`
`Szpital Rejonowy im. dr J. Rostka w Raciborzu
`
`Russian Federation
`
`Chelyabinsk, Russian Federation, 454087
`GBUZ "Cheliabinsky Regional Oncology
`Dispensary”
`
`Kazan, Russian Federation, 420029
`GAUZ Republican Clinical Oncology Dispensary
`of Minzdrav of Republic of Tatarstan
`
`Moscow, Russian Federation, 129128
`Non-State healthcare Indtitution Central Clinical
`Hospital # 2 named after N.A. Semashko OAO
`"RZhD"
`
`Novgorod, Russian Federation, 603001
`FBUZ Privolzhsky District Medical Center of
`FMBA
`
`Orel, Russian Federation, 302020
`Regional GUZ Orlovskiy Oncological Dispensary
`
`Saint-Petersburg, Russian Federation, 197022
`GBOU VPO "Saint-Petersburg State Medical
`University
`
`St. Petersburg, Russian Federation, 191104
`GUZ Leningradskiy Regional Oncology
`Dispensary
`
`Tula, Russian Federation, 300040
`
`https://clinicaltrials.gov/study/NCT01376297
`
`Page 7 of 17
`
`7117
`
`
`
`
`
`
`
`
`8/3/25, 3:12 PM Study Details | A Safety Study of Oral Netupitant and Palonosetron for the Prevention of Nausea and Vomiting | ClinicalTrials.gov
`
`GUZ Tula Regional Oncological Dispensary
`[Oncology]
`
`Tyumen, Russian Federation, 625041
`GBUZ Tyumen Regional Oncology Dispensary
`
`Ufa, Russian Federation, 450054
`GBUZ Republican Clinical Oncology Dispensary
`
`of Minzdrav of Republic of Bashkortostan
`
`Serbia
`
`Belgrade, Serbia, 11000
`Clinical Hospital Center Bezanijska Kosa
`
`Beograd, Serbia, 11000
`Institute of oncology and radiology of Serbia
`
`Kragujevac, Serbia, 34000
`Clinical Center Kragujevac
`
`Ukraine
`
`Chernivtsi, Ukraine, 58013
`Chernivtsi Regional Cancer Hospital [Outpatient
`Department]
`
`Dnipropetrovks, Ukraine, 49102
`Komunalnyi zaklad Miska bahatoprofilna
`
`klinichna likarnia #4
`
`Dnipropetrovsk, Ukraine, 49100
`KZ MKL19, MOTsr, vd khimter [viddilennia
`khimioterapii]
`
`Donetsk, Ukraine, 83092
`KKLPZ DnOPTsr [radio vd#3]
`
`Kharkiv, Ukraine, 61024
`DU IMR AMNU [vd khemter]
`
`Poltava, Ukraine, 36011
`Poltavskyi oblasnyi klinichnyi onkolohichnyi
`dyspanser Pol
`
`Uzhgorod, Ukraine, 88014
`Zakarpatskyi oblasnyi klinichnyi onkodyspanser
`[viddilennia
`
`Zaporizhia, Ukraine, 69040
`ZaOKOD [abdom vd]
`
`Participation Criteria
`https://clinicaltrials.gov/study/NCT01376297
`
`Page 8 of 17
`
`8/17
`
`
`
`
`
`
`
`
`8/3/25, 3:12 PM Study Details | A Safety Study of Oral Netupitant and Palonosetron for the Prevention of Nausea and Vomiting | ClinicalTrials.gov
`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).
`
`https://clinicaltrials.gov/study/NCT01376297 9/17
`
`Page 9 of 17
`
`
`
`
`
`
`
`
`8/3/25, 3:12 PM
`
`Study Details | A Safety Study of Oral Netupitant and Palonosetron for the Prevention of Nausea and Vomiting | ClinicalTrials.gov
`
`Eligibility Criteria
`
`Description
`
`Inclusion Criteria:
`
`Signed written informed consent.
`Naive to cytotoxic chemotherapy. Previous biological or hormonal therapy is permitted.
`Diagnosed with a malignant tumor.
`
`If scheduled to receive repeated consecutive courses of chemotherapy, a single dose of one
`or more of the following agents administered on Day 1 is allowed:
`
`o Highly emetogenic chemotherapy: any L.V. dose of cisplatin, mechlorethamine,
`streptozocin, cyclophosphamide more or equal to 1500 mg/m2, carmustine,
`dacarbazine;
`
`o Moderately emetogenic chemotherapy: any I.V. dose of oxaliplatin, carboplatin,
`epirubicin, idarubicin, ifosfamide, irinotecan, daunorubicin, doxorubicin,
`cyclophosphamide I.V. (less than 1500 mg/m2), cytarabine I.V. (more than 1 g/m?2),
`azacidine, alemtuzumab, bendamustine, or clofarabine.
`
`If scheduled to receive combination regimens, the most emetogenic agent is to be given as
`first on Day 1 and the infusion must be completed within 6 hours.
`
`If scheduled to receive chemotherapy agents of minimal to low emetogenic potential, they
`are to be given on Day 1 following the most emetogenic agent or on any subsequent study
`day.
`
`ECOG Performance Status of 0, 1, or 2
`
`Female patients of either non-childbearing potential or child-bearing potential with a
`commitment to use contraceptive methods throughout the clinical trial
`
`Hematologic and metabolic status adequate for receiving a moderately emetogenic
`regimen based on laboratory criteria (Total Neutrophils,Platelets, Bilirubin, Liver enzymes,
`Serum Creatinine or Creatinine Clearance)
`
`Exclusion Criteria:
`
`If female, lactating or pregnant
`
`Current use of illicit drugs or current evidence of alcohol abuse.
`
`Scheduled to receive either cyclophosphamide I.V. (500 to 1500 mg/m2) and I.V.
`doxorubicin (more or equal to 40 mg/m2) or cyclophosphamide I.V. (500 to 1500 mg/m?2)
`and 1.V. epirubicin (more or equal to 60 mg/m2).
`
`Scheduled to receive moderately or highly emetogenic chemotherapy from Day 2 to Day 5
`following Day 1 chemotherapy administration.
`
`Active infection or uncontrolled disease except for malignancy that may pose unwarranted
`risks in administering the study drugs to the patient.
`
`Known hypersensitivity or contraindication to 5-HT3 receptor antagonists or
`dexamethasone.
`
`https://clinicaltrials.gov/study/NCT01376297
`
`Page 10 of 17
`
`10/17
`
`
`
`
`
`
`
`
`8/3/25, 3:12 PM Study Details | A Safety Study of Oral Netupitant and Palonosetron for the Prevention of Nausea and Vomiting | ClinicalTrials.gov
`
`» Previously received an NK1 receptor antagonist
`
`» Participation in a clinical trial involving oral netupitant administered in combination with
`palonosetron.
`
`» Any investigational drugs taken within 4 weeks prior to Day 1 of cycle 1, and/or is scheduled
`to receive any investigational drug during the study.
`
`» Systemic corticosteroid therapy at any dose within 72 hours prior to Day 1 of cycle 1.
`Topical and inhaled corticosteroids with a steroid dose of less or equal to 10 mg of
`prednisone daily or its equivalent are permitted. Non-study drug dexamethasone as pre-
`medication in patients scheduled to receive taxanes is allowed.
`
`» 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 1 week
`prior to Day 1
`
`« Scheduled to receive any of the following CYP3A4 substrates: terfenadine, cisapride,
`astemizole, pimozide.
`
`e Scheduled to receive any CYP3A4 inducer or its intake within 4 weeks prior to Day 1
`
`« History or predisposition to cardiac conduction abnormalities, except for incomplete right
`bundle branch block.
`
`« History of risk factors for Torsade de Point (heart failure, hypokalemia, family history of
`Long QT Syndrome).
`
`» Severe cardiovascular diseases within 3 months prior to Day 1, including myocardial
`infarction, unstable angina pectoris, significant valvular or pericardial disease, history of
`ventricular tachycardia, symptomatic Congestive Heart Failure 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 for 4
`days such as systemic fungal infection or uncontrolled diabetes.
`
`Ages Eligible for Study @
`
`18 Years and older (Adult, Older Adult)
`
`Sexes Eligible for Study @
`
`All
`
`Accepts Healthy Volunteers @
`
`No
`
`https://clinicaltrials.gov/study/NCT01376297 1M/M17
`
`Page 11 of 17
`
`
`
`
`
`
`
`
`8/3/25, 3:12 PM Study Details | A Safety Study of Oral Netupitant and Palonosetron for the Prevention of Nausea and Vomiting | ClinicalTrials.gov
`
`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)
`
`https://clinicaltrials.gov/study/NCT01376297
`
`Page 12 of 17
`
`12/17
`
`
`
`
`
`
`
`
`8/3/25, 3:12 PM
`
`Study Details | A Safety Study of Oral Netupitant and Palonosetron for the Prevention of Nausea and Vomiting | ClinicalTrials.gov
`
`Arms and Interventions
`
`Participant Group/Arm
`o
`
`Experimental:
`Netupitant and
`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
`
`Active Comparator:
`Aprepitant and
`Palonosetron plus
`dexamethasone
`
`Oral aprepitant hard
`capsule 125 mg (on Day
`1) + 80 mg daily (for the
`following two days) and
`oral palonosetron soft
`capsule 0.50 mg (on
`Day 1) given with oral
`dexamethasone at each
`scheduled
`chemotherapy cycle.
`
`Intervention/Treatment ©@
`
`Drug: Netupitant and Palonosetron
`Drug: Dexamethasone
`
`Drug: Aprepitant
`Drug: Palonosetron
`Drug: Dexamethasone
`
`What is the study measuring?
`
`Primary Outcome Measures o
`
`https://clinicaltrials.gov/study/NCT01376297
`
`Page 13 of 17
`
`13/17
`
`
`
`
`
`
`
`
`8/3/25, 3:12 PM
`
`Study Details | A Safety Study of Oral Netupitant and Palonosetron for the Prevention of Nausea and Vomiting | ClinicalTrials.gov
`
`Outcome
`Measure
`
`Percentage of
`Patients With
`Adverse Events
`
`Measure Description
`
`This was a safety study where Adverse Events
`is the primary outcome (defined by the current
`ICH Guideline for Good Clinical Practice).
`Patients were randomized according to a 3:1
`ratio
`
`(netupitant/palonosetron:aprepitant/palonoset
`
`ron). No formal comparison was planned, the
`presence of a control in the same patient
`population helped interpret any unexpected
`safety finding in the experimental arm.The
`number of patients was estimated in order to
`have more than 100 patients treated with the
`netupitant/palonosetron comination for up to
`at least six cycles. Based on 100 patients, if a
`given AE is not observed, an AE incidence of
`3% or greater can be excluded with 95%
`confidence.
`
`Collaborators and Investigators
`This is where you will find people and organizations involved with this study.
`
`Sponsor @
`
`https://clinicaltrials.gov/study/NCT01376297
`
`Page 14 of 17
`
`Time
`Frame
`
`Particip
`ants
`will be
`followe
`d for
`the
`duratio
`n of the
`chemot
`herapy,
`an
`expecte
`d
`average
`duratio
`n of up
`to 24
`weeks
`assumi
`ng 6
`chemot
`herapy
`cycles
`given
`every 4
`
`weeks
`
`14/17
`
`
`
`
`
`
`
`
`8/3/25, 3:12 PM Study Details | A Safety Study of Oral Netupitant and Palonosetron for the Prevention of Nausea and Vomiting | ClinicalTrials.gov
`
`Helsinn Healthcare SA
`
`Collaborators @
`
`e Parexel
`
`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.
`
`o Schwartzberg L, Karthaus M, Rossi G, Rizzi G, Borroni ME, Rugo HS, Jordan K, Hansen V. Fixed
`combination of oral NEPA (netupitant-palonosetron) for the prevention of acute and delayed
`
`chemotherapy-induced nausea and vomiting_in patients receiving multiple cycles of
`
`chemotherapy: Efficacy data from 2 randomized, double-blind phase Il studies. Cancer Med.
`2019 May;8(5):2064-2073. doi: 10.1002/cam4.2091. Epub 2019 Apr 9.
`(https://pubmed.ncbi.nlm.nih.gov/30968588),
`
`» Rugo HS, Rossi G, Rizzi G, Aapro M. Efficacy of NEPA (netupitant/palonosetron) across multiple
`
`cycles of chemotherapy in breast cancer patients: A subanalysis from two phase Il trials. Breast.
`2017 Jun;33:76-82. doi: 10.1016/j.breast.2017.02.017. Epub 2017 Mar 10.
`(https://pubmed.ncbi.nim.nih.gov/28285236)
`
`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 @
`
`2011-06-16 HHS Vulnerability Disclosure
`
`First Submitted that Met QC Criteria @
`2011-06-17
`First Posted (Estimated) @
`
`https://clinicaltrials.gov/study/NCT01376297 15/17
`
`Page 15 of 17
`
`
`
`
`
`
`
`
`8/3/25, 3:12 PM Study Details | A Safety Study of Oral Netupitant and Palonosetron for the Prevention of Nausea and Vomiting | ClinicalTrials.gov
`2011-06-20
`
`Results Reporting Dates
`
`Results First Submitted @
`2014-11-06
`
`Results First Submitted that Met QC Criteria @
`2014-11-06
`
`Results First Posted (Estimated) @
`2014-11-17
`
`Certification/Extension Dates
`
`Certification/Extension First Submitted @
`
`2013-01-16
`
`Certification/Extension First Submitted that Met QC Criteria @
`2013-01-16
`
`Certification/Extension First Posted (Estimated) @
`
`2013-01-25
`
`Study Record Updates
`
`Last Update Submitted that met QC Criteria @
`2014-11-06
`
`Last Update Posted (Estimated) @
`2014-11-17
`
`Last Verified @
`2014-11
`
`More Information
`
`Terms related to this study
`
`Additional Relevant MeSH Terms
`
`Signs and Symptoms, Digestive
`
`https://clinicaltrials.gov/study/NCT01376297 16/17
`
`Page 16 of 17
`
`
`
`
`
`
`
`
`8/3/25, 3:12 PM Study Details | A Safety Study of Oral Netupitant and Palonosetron for the Prevention of Nausea and Vomiting | ClinicalTrials.gov
`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
`Neurokinin-1 Receptor Antagonists
`Neurotransmitter Agents
`Molecular Mechanisms of Pharmacological Action
`Serotonin 5-HT3 Receptor Antagonists
`Serotonin Antagonists
`Serotonin Agents
`Dexamethasone
`Aprepitant
`Palonosetron
`
`https://clinicaltrials.gov/study/NCT01376297 17/17
`
`Page 17 of 17
`
`
`
`
`
`
`
`
`