Completed
`An Efficacy and Safety Study of Intravenous Palonosetron Administered as an
`Infusion and as a Bolus for the Prevention of Nausea and Vomiting
`ClinicalTrials.gov ID NCT02557035
`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
`PALO-15-17 is a clinical study assessing efficacy and safety of a single dose of palonosetron 0.25 mg
`administered as a 30-minute IV infusion compared to palonosetron 0.25 mg administered as a 30-
`second IV bolus (Aloxi, an antiemetic drug), both given with oral dexamethasone. The objective of the
`study is to demonstrate that infused IV palonosetron 0.25 mg is as effective as (non-inferior to) injected
`palonosetron IV 0.25 mg to prevent nausea and vomiting induced by highly emetogenic cancer
`chemotherapy in the 0-24 hours after administration of a single cycle of highly emetogenic
`chemotherapy
`Official Title
`A Phase 3, Single-dose, Multicenter, Randomized, Double-blind, Parallel Group Study to Assess the
`Efficacy and Safety of Palonosetron 0.25 mg Administered as a 30-minute IV Infusion Compared to
`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, 4:10 PM Study Details | An Efficacy and Safety Study of Intravenous Palonosetron Administered as an Infusion and as a Bolus for the Prevent…
`https://clinicaltrials.gov/study/NCT02557035 1/16
`HELSINN EXHIBIT 2030
`Azurity Pharmaceuticals, Inc. v. Helsinn Healthcare S.A.
`IPR2025-00945
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`Palonosetron 0.25 mg Administered as a 30-second IV Bolus for the Prevention of Chemotherapy-
`induced Nausea and Vomiting in Cancer Patients Receiving Highly Emetogenic Chemotherapy.
`Conditions
`Chemotherapy-Induced Nausea and Vomiting
`Intervention / Treatment
`Drug: Palonosetron
`Drug: Dexamethasone
`Other Study ID Numbers
`Study Start
`2015-10
`Primary Completion (Actual)
`2016-03
`Study Completion (Actual)
`2016-03
`Enrollment (Actual)
`441
`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&query=Dexamethasone)Dexamethasone sodium
`phosphate(https://dailymed.nlm.nih.gov/dailymed/search.cfm?
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`labeltype=human&query=Dexamethasone+sodium+phosphate)Dexamethasone
`acetate(https://dailymed.nlm.nih.gov/dailymed/search.cfm?
`labeltype=human&query=Dexamethasone+acetate)
`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 76 locations
`Belarus
`Lesnoy, Belarus, 223052
`N.N. Aleksandrov Republican Research
`Oncology and Medical Radiology Center,
`Department of Chemotherapy
`Minsk, Belarus, 220013
`Minsk City Clinical Oncology Center
`Bosnia and Herzegovina
`Banja Luka, Bosnia and Herzegovina
`University Clinical Centre of the Republic of
`Srpska
`Bulgaria
`Dobrich, Bulgaria, 9300
`Multiprofile Hospital for Active Treatment,
`Dobrich, Department of Medical Oncology
`Haskovo, Bulgaria, 6300
`Specialized Hospital for Active Treatment in
`Oncology, Haskovo, Department of Medical
`Oncology
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`Plovdiv, Bulgaria, 4002
`Multiprofile Hospital for Active Treatment
`"Central Onco Hospital", Plovdiv, Department of
`Medical Oncology
`Rousse, Bulgaria, 7002
`Complex Oncology Center, Ruse, Department of
`Medical Oncology
`Sofia, Bulgaria, 1303
`Multiprofile Hospital for Active Treatment
`"Serdika", Sofia, Department of Medical
`Oncology
`Sofia, Bulgaria, 1431
`University Multiprofile Hospital for Active
`Treatment "Sveti Ivan Rilski", Sofia, Department
`of Medical Oncology
`Sofia, Bulgaria
`Multiprofile Hospital for Active Treatment for
`Wonen's Health "Nadezhda"
`Varna, Bulgaria, 9010
`Hospital for Active Treatment of Oncological
`Diseases "Dr. Marko Antonov Markov", Varna,
`Department of Medicinal Oncology and
`Palliative Care
`Varna, Bulgaria, 9010
`Multiprofile Hospital for Active Treatment "Sveta
`Marina", Varna, Clinic of Medical Oncology
`Georgia
`Tbilisi, Georgia, 0131
`JSC NeoMedi
`Tbilisi, Georgia, 0159
`LTD Institute of Clinical Oncology
`Tbilisi, Georgia, 0160
`LTD Aversi Clinic
`Tbilisi, Georgia
`LDT High Technology Medical Center University
`Clinic
`Greece
`Athens, Greece
`"Sotiria" Chest Diseases Hospital of Athens
`Thessaloniki, Greece, 570 01
`Thermi Clinic S.A.
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`Thessaloniki, Greece, 570 10
`General Hospital of Thessaloniki "G.
`Papanikolaou", University Department of
`Pulmonology
`Thessaloniki, Greece
`Bioclinic Thessalonikis S.A.
`Hungary
`Budapest, Hungary, 1121
`Koranyi National Institute of TBC and
`Pulmonology
`Budapest, Hungary, 1145
`Uzsoki Hospital, Department of Radiation
`Oncology
`Debrecen, Hungary
`University of Debrecen, Medical and Health
`Science Center
`Gyor, Hungary, 9024
`Petz Aladar County Teaching Hospital, Center
`for Oncoradiology
`Kaposvár, Hungary, 7400
`Kaposi Mor Teaching Hospital, Centre for
`Clinical Oncology
`Miskolc, Hungary, 3526
`Borsod-Abauj-Zemplen County Hospital and
`University Educational Hospital
`Nyíregyháza, Hungary
`Szabolcs-Szatmar-Bereg County Hospitals and
`University Teaching Hospital
`Pecs, Hungary
`Medical Center of the University of Pecs
`Lithuania
`Kaunas, Lithuania, 45434
`Hospital of Lithuanian University of Health
`Sciences Kaunas Clinics, Oncology Hospital,
`Department of Conservative Oncology
`Kaunas, Lithuania, 50009
`Hospital of Lithuanian University of Health
`Sciences Kaunas Clinics, Clinic of Oncology and
`Hematology
`Romania
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`Baia Mare, Romania
`Oncopremium Team SRL, Department of
`Oncology
`Bucharest, Romania, 022328
`Prof. Dr. Alexandru Trestioreanu Institute of
`Oncology, Medical Oncology Department II
`Bucharest, Romania, 030171
`Coltea Clinical Hospital, Department of Medical
`Oncology
`Bucharest, Romania, 031864
`Hifu Terramed Conformal SRL, Department of
`Medical Oncology
`Bucharest, Romania
`Ianuli Med Consult SRL, Oncology Department
`Cluj-Napoca, Romania, 400015
`"Prof. Dr. Ion Chiricuta" Institute of Oncology,
`Radiotherapy Department I
`Cluj-Napoca, Romania
`Radiotherapy Center Cluj SRL, Department of
`Oncology
`Constanta, Romania, 900591
`Constanta Emergency Clinical County Hospital,
`Department of Medical Oncology
`Craiova, Romania
`Oncology Center "Sf. Nectarie", Department of
`Medical Oncology
`Suceava, Romania, 720237
`Suceava Sf. Ioan cel Nou Emergency County
`Hospital, Department of Medical Oncology
`Timisoara, Romania, 300239
`Oncomed SRL, Department of Medical Oncology
`Timisoara, Romania
`Oncocenter Clinical Oncology SRL, Department
`of Medical Oncology
`Russian Federation
`Arkhangelsk, Russian Federation
`Arkhangelsk Clinical Oncology Center
`Barnaul, Russian Federation
`Altay Territorial Oncology Center
`Bryansk, Russian Federation
`Bryansk Regional Oncology Center
`Chelyabinsk, Russian Federation
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`Chelyabinsk Regional Clinical Oncology Center
`Chelyabinsk, Russian Federation
`Evimed, LLC
`Ekaterinburg, Russian Federation
`Sverdlovsk Regional Oncology Center
`Ivanovo, Russian Federation
`Ivanovo Regional Oncology Center
`Kaluga, Russian Federation
`Kaluga Regional Oncology Center
`Kazan, Russian Federation
`Republican Clinical Oncology Center
`Krasnoyarsk, Russian Federation
`Krasnoyarsk A.I. Kryzhanovsky Regional
`Oncology Center
`Moscow, Russian Federation
`Moscow City Oncology Hospital #62
`Moscow, Russian Federation
`Moscow Clinical Scientific and Practical Center
`Moscow, Russian Federation
`N.N. Blokhin Russian Oncology Research Center,
`Surgery Dept. 2
`Moscow, Russian Federation
`N.N. Blokhin Russian Oncology Research Center,
`Surgery Dept. of Female Reproductive System
`Tumors
`Moscow, Russian Federation
`N.N. Blokhin Russian Oncology Research Center
`Nizhny Novgorod, Russian Federation
`Branch #1 of Nizhny Novgorod Regional
`Oncology Center
`Novosibirsk, Russian Federation
`City Clinical Hospital #1
`Novosibirsk, Russian Federation
`Novosibirsk Regional Oncology Center
`Omsk, Russian Federation
`Clinical Oncology Center, Dept. of
`Chemotherapy
`Omsk, Russian Federation
`Clinical Oncology Center
`Orenburg, Russian Federation
`Orenburg Regional Clinical Oncology Center
`Pyatigorsk, Russian Federation
`Pyatigorsk Oncology Center
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`Ryazan, Russian Federation
`Regional Clinical Oncology Center
`Samara, Russian Federation
`Samara Regional Clinical Oncology Center
`St. Petersburg, Russian Federation
`City Clinical Oncology Center, Thoracic
`Oncology Dept.
`St. Petersburg, Russian Federation
`City Clinical Oncology Center, Urology Oncology
`Dept.
`St. Petersburg, Russian Federation
`City Clinical Oncology Center
`St. Petersburg, Russian Federation
`First I.P. Pavlov State Medical University of St.
`Petersburg
`St. Petersburg, Russian Federation
`St.Petersburg Municipal Clinical Oncology
`Center
`Tambov, Russian Federation
`Tambov Regional Oncology Center
`Tomsk, Russian Federation
`Tomsk Research Institute of Oncology, General
`Oncology Dept.
`Tomsk, Russian Federation
`Tomsk Research Institute of Oncology
`Ufa, Russian Federation
`Republican Clinical Oncology Center
`Veliky Novgorod, Russian Federation
`Regional Clinical Oncology Center
`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:
`Signed written informed consent
`Histologically or cytologically confirmed solid tumor malignancy.
`Naïve to cytotoxic chemotherapy. Previous biological or hormonal therapy will be permitted.
`Scheduled to receive first course of one of the following reference 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) >250 mg/m2
`dacarbazine (DTIC)
`mechloretamine (nitrogen mustard)
`Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 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.
`Exclusion Criteria:
`Lactating woman.
`Current use of illicit drugs or current evidence of alcohol abuse.
`Scheduled to receive moderately emetogenic chemotherapy or highly emetogenic
`chemotherapy from Day 2 to Day 5.
`Received or is scheduled to receive radiation therapy to the abdomen or the pelvis within 1
`week prior to the start of the reference HEC administration on Day 1 or between Days 1 to 5.
`Any vomiting, retching, or nausea (grade ≥ 1 as defined by National Cancer Institute) within
`24 hours prior to the start of the reference HEC administration on Day 1.
`Symptomatic primary or metastatic CNS malignancy.
`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) or pose unwarranted risks in administering the study drugs
`to the patient.
`Known hypersensitivity or contraindication to 5-HT3 receptor antagonists
`Known contraindication to the IV administration of 50 mL 5% glucose solution.
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`Participation in a previous clinical trial involving 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 the
`reference HEC administration on Day 1. However, topical and inhaled corticosteroids are
`permitted.
`Scheduled to receive bone marrow transplantation and/or stem cell rescue therapy.
`Any medication with known or potential antiemetic activity within 24 hours prior to the start
`of the reference HEC administration on Day 1, including but not limited to 5-HT3 receptor
`antagonists and NK-1 receptor antagonists
`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
`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: I.V.
`palonosetron infusion
`plus dexamethasone
`Intravenous
`palonosetron (Aloxi
`0.25 mg solution for
`injection) as an infusion
`with oral
`dexamethasone, both
`given on Day 1, prior to
`the scheduled start of
`cisplatin; then
`dexamethasone from
`Days 2 through 4.
`Drug: Palonosetron
`Drug: Dexamethasone
`Active Comparator: I.V.
`palonosetron bolus plus
`dexamethasone
`Intravenous
`palonosetron (Aloxi
`0.25 mg solution for
`injection) as a bolus
`with oral
`dexamethasone, both
`given on Day 1, prior to
`the scheduled start of
`cisplatin; then
`dexamethasone from
`Days 2 through 4.
`Drug: Palonosetron
`Drug: Dexamethasone
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`What is the study measuring?
`Primary Outcome Measures
`Secondary Outcome Measures
`Outcome
`Measure Measure Description Time
`Frame
`Percentage of
`Patients With
`Complete
`Response (CR)
`Defined as no
`Emesis, no
`Rescue
`Medication, in
`the Acute
`Phase
`0-24
`hours
`Outcome
`Measure Measure Description Time
`Frame
`Percentage of
`Patients With
`Complete
`Response (CR)
`Defined as no
`Emesis, no
`Rescue
`Medication, in
`the Delayed
`Phase
`>24-120
`hours
`Percentage of
`Patients With
`Complete
`0-120
`hours
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`Response (CR)
`Defined as no
`Emesis, no
`Rescue
`Medication, in
`the Overall
`Phase
`Percentage of
`Patients With
`no Emetic
`Episodes in the
`Acute Phase
`0-24
`hours
`Percentage of
`Patients With
`no Emetic
`Episodes in the
`Delayed Phase
`>24-120
`hours
`Percentage of
`Patients With
`no Emetic
`Episodes in the
`Overall Phase
`0-120
`hours
`Percentage of
`Patients With
`no Rescue
`Medication in
`the Acute
`Phase
`0-24
`hours
`Percentage of
`Patients With
`no Rescue
`Medication in
`>24-120
`hours
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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
`2015-09-21
`First Submitted that Met QC Criteria
`2015-09-21
`First Posted (Estimated)
`2015-09-22
`the Delayed
`Phase
`Percentage of
`Patients With
`no Rescue
`Medication in
`the Overall
`Phase
`0-120
`hours
`Sponsor
`Collaborators
`PSI CRO
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`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
`Certification/Extension Dates
`Certification/Extension First Submitted
`2016-03-23
`Certification/Extension First Submitted that Met QC Criteria
`2016-03-23
`Certification/Extension First Posted (Estimated)
`2016-04-26
`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
`Nausea
`Vomiting
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`HHS Vulnerability Disclosure
`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
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