Completed
`A Study to Assess the Safety and the Efficacy of IV Fosnetupitant/
`Palonosetron (260 mg/ 0.25 mg) Combination Compared to Oral Netupitant/
`Palonosetron (300 mg/ 0.5 mg) Combination for the Prevention of CINV in AC
`Chemotherapy in Women With Breast Cancer
`ClinicalTrials.gov ID NCT03403712
`Sponsor Helsinn Healthcare SA
`Information provided by Helsinn Healthcare SA (Responsible Party)
`Last Update Posted 2020-06-01
`Study Details Tab
`Study Overview
`Brief Summary
`Multicenter, randomized, double-blind, double-dummy, parallel group, stratified study assessing the
`safety and describing the efficacy of a single dose of intravenous (IV) fosnetupitant/palonosetron (260
`mg/0.25 mg) infusion [test] versus oral netupitant/palonosetron (300 mg/0.5 mg) combination
`[control]; each administered with oral dexamethasone prior to initial and repeated cycles of AC
`chemotherapy in female breast cancer patients.
`Official Title
`A Multicenter, Randomized, Double-blind, Double-dummy, Active-controlled, Parallel Group Phase 3b
`Study to Assess the Safety and to Describe the Efficacy of IV Fosnetupitant/Palonosetron (260 mg/0.25
`mg) Combination (IV NEPA FDC) Compared to Oral Netupitant/Palonosetron (300 mg/0.5 mg)
`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.
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`HELSINN EXHIBIT 2024
`Azurity Pharmaceuticals, Inc. v. Helsinn Healthcare S.A.
`IPR2025-00945
`Page 1 of 18
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`Combination (Akynzeo®) for the Prevention of Chemotherapy-induced Nausea and Vomiting in Initial
`and Repeated Cycles of Anthracycline-cyclophosphamide (AC) Chemotherapy in Women With Breast
`Cancer
`Conditions
`Chemotherapy-induced Nausea and Vomiting
`Intervention / Treatment
`Drug: fosnetupitant/ palonosetron
`Drug: netupitant/palonosetron
`Drug: dexamethasone
`Other Study ID Numbers
`Study Start (Actual)
`2018-03-16
`Primary Completion (Actual)
`2018-09-19
`Study Completion (Actual)
`2018-09-19
`Enrollment (Actual)
`404
`Study Type
`Interventional
`Phase
`Phase 3
`Resource links provided by the National Library of Medicine
`MedlinePlus Genetics(https://medlineplus.gov/genetics/) related topics:  Breast
`cancer(https://medlineplus.gov/genetics/condition/breast-cancer)
`MedlinePlus(https://medlineplus.gov/) related topics:  Nausea and
`Vomiting(https://medlineplus.gov/nauseaandvomiting.html)
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`Drug Information(https://dailymed.nlm.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&query=Palonosetron)
`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 40 locations
`United States
`Arizona Locations
`Tucson, Arizona, United States, 85745
`The Oncology Inst. Of Hope and Innovation
`Arkansas Locations
`Little Rock, Arkansas, United States, 72205
`Carti Cancer Center
`California Locations
`Anaheim, California, United States, 92801
`Pacific Cancer Medical Center, Inc.
`Bakersfield, California, United States, 93309
`CBCC Global Research, INC at Comprehensive
`Blood and Cancer Center
`Corona, California, United States, 92882
`The Oncology Tnstitute of Hope and Innovation
`Inglewood, California, United States, 90305
`Uptimum Medical Group Inc.
`Long Beach, California, United States, 90805
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`The Oncology Institute of Hope and Innnovation
`Los Angeles, California, United States, 90033
`Hao Wei Zhang M.D.
`Redlands, California, United States, 92373
`Emad Ibrahim, MD, INC.
`Florida Locations
`Lakeland, Florida, United States, 33805
`Watson Clinic LLP
`Orange City, Florida, United States, 32763
`Mid Florida Hematology and Oncology Center
`Georgia Locations
`Athens, Georgia, United States, 30607
`University Cancer & Blood Center, LLC
`Dublin, Georgia, United States, 31021
`Cancer Center of !\!Iiddle Georgia
`Rome, Georgia, United States, 30165
`Harbin Clinic
`Savannah, Georgia, United States, 31404
`Summit Cancer Care
`Illinois Locations
`Skokie, Illinois, United States, 60076
`Edward H. Kaplan MD & Associates
`Skokie, Illinois, United States, 60077
`Presence Infusion Care - Skokie
`Indiana Locations
`Fort Wayne, Indiana, United States, 46845
`Fort Wayne Medical Oncology and Hematology,
`Inc.
`Lafayette, Indiana, United States, 47904
`TU Health Arnett Cancer Center
`New Albany, Indiana, United States, 47150
`Baptist Health Cancer Center
`Kansas Locations
`Topeka, Kansas, United States, 66606
`Cotton O'Neil Clinical Res. Ctr., Hematology &
`Oncology
`Wichita, Kansas, United States, 67214
`Cancer Center of Kansas
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`Kentucky Locations
`Ashland, Kentucky, United States, 41101
`Ashland-Bellefonte Cancer Center
`Louisiana Locations
`Shreveport, Louisiana, United States, 71105
`CHRISTUS Cancer Treatment Center
`Maryland Locations
`Baltimore, Maryland, United States, 21202
`Mercy Medical Center, Medical Oncology and
`Hematology
`Mississippi Locations
`Hattiesburg, Mississippi, United States, 39401
`Hattiesburg Clinic Hematology Oncology
`Missouri Locations
`Joplin, Missouri, United States, 64804
`Cornell-Beshore Cancer Institute
`Springfield, Missouri, United States, 65807
`Cox Mcdical ·Centers
`New Jersey Locations
`Elizabeth, New Jersey, United States, 07207
`Trinitas Cancer Center
`New Mexico Locations
`Farmington, New Mexico, United States,
`87401
`San Juan Oncology Associates
`Ohio Locations
`Columbus, Ohio, United States, 43219
`Mid Ohio Oncology/Hematology Inc. DBA The
`Mark H. Zangmeister Center
`Toledo, Ohio, United States, 43623
`Toledo Clinic Cancer Center - Toledo
`Pennsylvania Locations
`Monongahela, Pennsylvania, United States,
`15063
`Monongahela Valley Hospital
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`South Carolina Locations
`Rock Hill, South Carolina, United States,
`29732
`Carolina Blood and Cancer Care Associates, P.A.
`Tennessee Locations
`Germantown, Tennessee, United States,
`38138
`The West Clinic, PC dba West Cancer Center
`Wyoming Locations
`Cheyenne, Wyoming, United States, 82001
`Cheyenne Regional Medical Center
`Georgia
`Kutaisi, Georgia, 4600
`JSC Saint Nikolozi Surgery and Oncological
`Centre
`Tbilisi, Georgia, 0159
`LTD Institute of Clinical Oncology
`Tbilisi, Georgia, 0159
`LTD Tbilisi Oncology Dispensary
`Tbilisi, Georgia, 0179
`LTD S.Khechinashvili University 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:
`Cycle 1:
`The following inclusion criteria must be checked prior to inclusion at Cycle 1:
`1. Patient read, understood and signed the written informed consent before any study related
`activity, agreeing to participate in the study and to comply with study requirements.
`2. Female patient of at least 8 years of age.
`3. Histologically or cytologically confirmed breast cancer, including recurrent or metastatic.
`4. Naïve to moderately or highly emetogenic antineoplastic agents.
`5. Scheduled to receive at least 4 consecutive cycles of an AC combination regimen.
`Notes:
`1. additional not emetogenic, minimally or low emetogenic antineoplastic agents are
`permitted at any time after start of AC combination on Day 1.
`2. additional highly or moderately emetogenic antineoplastic agents are only allowed on
`Day 1 after the start of AC combination, provided their administration is completed
`within 6 hours from the start of the AC combination administration.
`6. ECOG Performance Status of 0 or 1.
`7. Patient shall be: a) of non-childbearing potential or b) of childbearing potential using
`reliable contraceptive measures and having a negative urine pregnancy test within 24 hours
`prior to dose of investigational product.
`Notes:
`1. Female patients of non-childberaring potential are defined as being in post-
`menopausal state since at least 1 year; or having documented surgical sterilization or
`hysterectomy at least 3 months before study participation.
`2. Reliable contraceptive measures include implants, injectables, combined oral
`contraceptives, intrauterine devices, vasectomized partner or complete (long term)
`sexual abstinence;
`8. Hematologic and metabolic status adequate for receiving a cycle of AC chemotherapy
`based on investigator's assessment.
`9. If the patient has a known hepatic or renal impairment, she may be enrolled in the study at
`the discretion of the Investigator.
`10. Able to read, understand, follow the study procedure and complete the patient diary.
`All inclusion criteria will be checked at screening visit (Visit 1 of Cycle 1); inclusion criteria 7 will
`be re-checked at Day 1 (Visit 2).
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`Cycles 2 to 4:
`The following inclusion criteria must be checked prior to inclusion at each repeated cycle:
`1. 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.
`2. Scheduled to receive an AC chemotherapy regimen or AC chemotherapy together with other
`chemotherapies as defined in Inclusion criterion #5 for Cycle 1.
`3. Patient shall be: a) of non-childbearing potential or b) of childbearing potential using
`reliable contraceptive measures and having a negative urine pregnancy test within 24 hours
`prior to dosing of investigational product.
`4. Adequate hematologic and metabolic status for receiving a cycle of AC chemotherapy
`according to the Investigator's opinion.
`All inclusion criteria will be checked at screening visit (Visit 1); inclusion criterion #3 will be re-
`checked at Day 1 (Visit 2).
`Exclusion Criteria:
`Cycle 1:
`The following exclusion criteria must be checked prior to inclusion at Cycle 1:
`1. Lactating patient.
`2. Current use of illicit drugs or current evidence of alcohol abuse.
`3. Scheduled to receive moderately or highly emetogenic antineoplastic agent in addition to
`the AC regimen, from 6 hours after the start of the AC chemotherapy on Day 1 and up to
`Day 1 of Cycle 2.
`4. Received or is scheduled to receive radiation therapy to the abdomen or the pelvis within 1
`week prior to the start of AC chemotherapy administration on Day 1 or between Days 1 to 5,
`inclusive.
`5. Any vomiting, retching, or nausea (grade 1 as defined by National Cancer Institute) within 24
`hours prior to the start of AC chemotherapy administration on Day 1.
`6. Symptomatic primary or metastatic central nervous system (CNS) malignancy.
`7. Active peptic ulcer disease, gastrointestinal obstruction, increased intracranial pressure,
`hypercalcemia, an active infection or any illness or medical conditions (other than
`malignancy) that, in the opinion of the Investigator, may confound the results of the study,
`represent another potential etiology for emesis and nausea (other than chemotherapy-
`induced nausea and vomiting [CINV]) or pose unwarranted risks in administering the study
`drugs to the patient.
`8. Known hypersensitivity or contraindication to 5 hydroxytryptamine type 3 (5-HT3) receptor
`antagonists (e.g., palonosetron, ondansetron, granisetron, dolasetron, tropisetron,
`ramosetron), to dexamethasone, or to neurokinin-1 (NK1) receptor antagonists (e.g.,
`aprepitant, rolapitant).
`9. Known contraindication to the IV administration of 50 mL 5% glucose solution.
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`10. Participation in a previous clinical trial involving IV fosnetupitant or oral netupitant
`administered alone or in combination with palonosetron.
`11. Any investigational drugs taken within 4 weeks prior to Day 1, and/or is scheduled to
`receive any investigational drug (other than those planned by the study protocol) during the
`present study.
`12. Systemic corticosteroid therapy within 72 hours prior to the start of AC chemotherapy
`administration on Day 1, except the dexamethasone provided as additional study drug.
`However, topical and inhaled corticosteroids are permitted.
`13. Scheduled to receive bone marrow transplantation and/or stem cell rescue therapy during
`the study participation.
`14. Other than as administered as part of the study protocol, any medication with known or
`potential antiemetic activity within 24 hours prior to the start of AC chemotherapy
`administration on Day 1, including:
`5-HT3 receptor antagonists (e.g., ondansetron, granisetron, dolasetron, tropisetron,
`ramosetron, palonosetron)
`NK1 receptor antagonists (e.g., aprepitant, fosaprepitant, rolapitant or any other new
`drug of this class)
`benzamides (e.g., metoclopramide, alizapride)
`phenothiazines (e.g., prochlorperazine, promethazine, fluphenazine, perphenazine,
`thiethylperazine, chlorpromazine)
`benzodiazepines (except if the subject is receiving such medication for sleep or
`anxiety and has been on a stable dose for at least seven days prior to Day 1).
`butyrophenones (e.g., haloperidol, droperidol)
`anticholinergics (e.g., scopolamine, with the exception of inhaled anticholinergics for
`respiratory disorders, e.g., ipratropium bromide)
`antihistamines (e.g., cyclizine, hydroxyzine, diphenhydramine, chlorpheniramine)
`domperidone
`mirtazapine
`olanzapine
`prescribed cannabinoids (e.g., tetrahydrocannabinol or nabilone)
`Over The Counter (OTC) antiemetics, OTC cold or OTC allergy medications.
`15. Scheduled to receive any strong or moderate inhibitor of CYP3A4 during the efficacy
`assessment period (Day 1 to Day 5, inclusive) or its intake within 1 week prior to Day 1.
`16. Scheduled to receive any CYP3A4 inducer during the efficacy assessment period (Day 1 to
`Day 5, inclusive) or its intake within 4 weeks prior to Day 1, with the exception of
`corticosteroids (for which exclusion criterion #12 applies).
`17. History or predisposition to cardiac conduction abnormalities, except for incomplete right
`bundle branch block.
`18. History of risk factors for Torsades de Pointes (heart failure, hypokalemia, family history of
`Long QT Syndrome).
`19. Severe or uncontrolled cardiovascular diseases, including myocardial infarction within 3
`months prior to Day 1, unstable angina pectoris, significant valvular or pericardial disease,
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`history of ventricular tachycardia, symptomatic Congestive Heart Failure (CHF) New York
`Heart Association (NYHA) class III-IV, and severe uncontrolled arterial hypertension.
`All exclusion criteria with the exception of criteria #5, #12, and #14 will be checked at screening
`visit (Visit 1). Exclusion criteria #5, #12, and #14 will be checked at Day 1 (Visit 2) only.
`Exclusion criteria #3, #4, #7, #11, #13, #15, and #16 need to be re-checked at Day 1 (Visit 2).
`Cycles 2 to 4:
`The following exclusion criteria must be checked prior to inclusion at each repeated cycle:
`1. Scheduled to receive moderately or highly emetogenic antineoplastic agent in addition to
`the AC regimen, from 6 hours after the start of the AC chemotherapy on Day 1 of current
`cycle and up to Day 1 of the next cycle.
`2. Active infection or uncontrolled disease that may pose unwarranted risks in administering
`the study drugs to the patient.
`3. Started any of the prohibited medications.
`4. Any vomiting, retching, or nausea (grade ≥ 1 as defined by National Cancer Institute) within
`24 hours prior to the start of AC chemotherapy administration on Day 1.
`5. Received or is scheduled to receive radiation therapy to the abdomen or the pelvis within 1
`week prior to the start of AC chemotherapy administration on Day 1 or between Days 1 to 5.
`6. Symptomatic primary or metastatic CNS malignancy.
`7. Any illness or medical condition that, in the opinion of the investigator, may confound the
`results of the study or pose unwarranted risks in administering the investigational product
`or dexamethasone to the patient.
`All exclusion criteria, with exception of criterion #4, will be checked at screening visit (Visit 1).
`Exclusion criterion #4 will be checked at Day 1 (Visit 2) only. Exclusion criteria #2, #3 and #5 need
`to be re-checked at Day 1 (Visit 2).
`Ages Eligible for Study
`18 Years and older (Adult,  Older Adult)
`Sexes Eligible for Study
`Female
`Accepts Healthy Volunteers
`No
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`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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`Arms and Interventions
`Participant Group/ArmIntervention/Treatment
`Experimental: Test
`group
`intravenous
`fosnetupitant/
`palonosetron (260
`mg/0.25 mg) fixed-dose
`combination,
`administered as a 30-
`minute infusion of a 50
`mL solution, on Day 1 of
`each cycle.
`Oral dexamethasone
`will be administered on
`Day 1 of each cycle (12
`mg)
`Drug: fosnetupitant/ palonosetron
`intravenous fosnetupitant/ palonosetron (260
`mg/0.25 mg) fixed-dose combination
`Other Names:
`IV NEPA FDC
`Drug: dexamethasone
`Oral dexamethasone (12 mg)
`Active Comparator:
`Control group
`oral
`netupitant/palonosetron
`(300 mg/0.50 mg) fixed-
`dose combination on
`Day 1 of each cycle.
`Oral dexamethasone
`will be administered on
`Day 1 of each cycle (12
`mg)
`Drug: netupitant/palonosetron
`oral netupitant/palonosetron (300 mg/0.50
`mg) fixed-dose combination
`Other Names:
`Akynzeo capsules
`Drug: dexamethasone
`Oral dexamethasone (12 mg)
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`What is the study measuring?
`Primary Outcome Measures
`Outcome
`Measure Measure Description Time
`Frame
`Number of
`Participants
`With
`Treatment-
`emergent AEs
`at Cycle 1
`At the
`end of
`Cycle 1
`(each
`cycle is
`21
`days)
`Number of
`Participants
`With
`Treatment-
`emergent AEs
`All Cycles
`At the
`end of
`Cycle 4
`(each
`cycle is
`21
`days)
`Number of
`Participants
`With Severe
`(i.e., CTCAE
`Grade ≥3)
`TEAEs
`Reported for
`≥2% of Patients
`in Either
`Treatment
`Group and
`Overall
`Throughout the
`Study
`At the
`end of
`Cycle 4
`(each
`cycle is
`21
`days)
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`Secondary Outcome Measures
`Number of
`Participants
`With Study-
`Drug-Related
`TEAEs
`Reported for
`≥2% of Patients
`in Either
`Treatment
`Group
`Throughout the
`Study
`At the
`end of
`Cycle 4
`(each
`cycle is
`21
`days)
`Outcome
`Measure Measure Description Time
`Frame
`Complete
`Response in
`Cycle 1 During
`the Acute
`Phase
`defined as no emetic episodes [vomit or retch]
`and no rescue medication
`24
`hours
`after
`the
`start of
`AC
`chemot
`herapy
`adminis
`tration
`Complete
`Response in
`Cycle 1 During
`the Delayed
`Phase
`defined as no emetic episodes [vomit or retch]
`and no rescue medication
`120
`hour
`after
`the
`start of
`AC
`chemot
`herapy
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`adminis
`tration
`Complete
`Response in
`Cycle 1 During
`the Overall
`Phase
`defined as no emetic episodes [vomit or retch]
`and no rescue medication
`0-120
`hours
`after
`the
`start of
`AC
`chemot
`herapy
`Overall
`Percentage of
`Patients With
`NIDL Based on
`FLIE Scores for
`Cycles 1
`Percentage (including two-sided 95% CI using
`Wilson score method) of patients with NIDL
`based on FLIE scores (overall, by domain, and
`by individual item) are summarized by
`treatment group. NIDL was defined as a score
`greater than 108 points, 54 points, and 6 points
`for total FLIE score, domain score, and single
`item score, respectively. Differences between
`treatment groups for total FLIE score and
`domain scores (nausea and vomiting) were
`presented with two-sided 95% CIs using the
`CMH method adjusted for region and age class
`strata and also using Newcombe-Wilson's
`method without strata adjustment.
`No Impact on Daily Life (NIDL) Based on
`Functional Living Index-Emesis (FLIE) Scores.
`The FLIE is a nausea and vomiting specific self
`report instrument comprised of two domains
`(nausea and vomiting) with nine identical items
`in each domain
`cycle 1
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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
`2018-01-04
`First Submitted that Met QC Criteria
`2018-01-10
`First Posted
`2018-01-19
`Results Reporting Dates
`Results First Submitted
`2020-03-17
`Results First Posted with QC Comments
`2020-03-31
`Results First Submitted that Met QC Criteria
`2020-04-02
`Results First Posted
`2020-04-15
`Sponsor
`Collaborators
`George Clinical Pty Ltd
`The Physicians' Services Incorporated Foundation
`8/3/25, 4:04 PM Study Details | A Study to Assess the Safety and the Efficacy of IV Fosnetupitant/Palonosetron (260 mg/0.25 mg) Combination Comp…
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`Study Record Updates
`Last Update Submitted that met QC Criteria
`2020-05-15
`Last Update Posted
`2020-06-01
`Last Verified
`2020-05
`More Information
`Terms related to this study
`HHS Vulnerability Disclosure
`Additional Relevant MeSH Terms
`Signs and Symptoms, Digestive
`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
`8/3/25, 4:04 PM Study Details | A Study to Assess the Safety and the Efficacy of IV Fosnetupitant/Palonosetron (260 mg/0.25 mg) Combination Comp…
`https://clinicaltrials.gov/study/NCT03403712 17/18
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`Plan for Individual Participant Data (IPD)
`Drug and device information, study documents, and helpful links
`Plan to Share Individual Participant Data (IPD)?
`Undecided
`Studies a U.S. FDA-Regulated Drug Product
`Yes
`Studies a U.S. FDA-Regulated Device Product
`No
`Study Protocol(https://cdn.clinicaltrials.gov/large-docs/12/NCT03403712/Prot_000.pdf)
`[PDF, 2.01MB, 2017-11-30]
`Statistical Analysis Plan(https://cdn.clinicaltrials.gov/large-
`docs/12/NCT03403712/SAP_001.pdf) [PDF, 1.24MB, 2018-12-12]
`Study Documents Provided by Helsinn Healthcare SA
`8/3/25, 4:04 PM Study Details | A Study to Assess the Safety and the Efficacy of IV Fosnetupitant/Palonosetron (260 mg/0.25 mg) Combination Comp…
`https://clinicaltrials.gov/study/NCT03403712 18/18
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