Completed
`An Efficacy and Safety Study of Oral and Intravenous Palonosetron for the
`Prevention of Nausea and Vomiting
`ClinicalTrials.gov ID NCT01363479
`SponsorHelsinn Healthcare SA
`Information provided by Helsinn Healthcare SA (Responsible Party)
`Last Update Posted 2021-09-22
`Study Details Tab
`Study Overview
`Brief Summary
`PALO-10-01 is a clinical study assessing efficacy and safety of a single oral dose of palonosetron
`compared to a single intravenous dose of palonosetron (Aloxi, an antiemetic drug), both given with oral
`dexamethasone. The objective of the study is to demonstrate that oral palonosetron 0.50 mg is as
`effective as (non-inferior to) 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
`Single-dose, Multicenter, Randomized, Double-blind, Double-dummy, Parallel Group Study to Assess the
`Efficacy and Safety of Oral Palonosetron 0.50 mg Compared to I.V. Palonosetron 0.25 mg Administered
`With Dexamethasone for the Prevention of Chemotherapy-induced Nausea and Vomiting in Cancer
`Patients Receiving Highly Emetogenic Cisplatin-based Chemotherapy
`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 2019
`Azurity Pharmaceuticals, Inc. v. Helsinn Healthcare S.A.
`IPR2025-00948
`Page 1 of 15
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`Conditions
`Chemotherapy-Induced Nausea and Vomiting
`Intervention / Treatment
`Drug: Oral palonosetron
`Drug: I.V. palonosetron
`Drug: Dexamethasone
`Other Study ID Numbers
`Study Start
`2011-07
`Primary Completion (Actual)
`2012-11
`Study Completion (Actual)
`2012-11
`Enrollment (Actual)
`743
`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?
`labeltype=human&query=Dexamethasone+sodium+phosphate)Dexamethasone
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`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 79 locations
`United States
`Arkansas Locations
`Hot Springs, Arkansas, United States, 71913
`Genesis Cancer Centre
`California Locations
`Corona, California, United States, 92879
`Compassionate Cancer Center
`Fountain Valley, California, United States,
`92708
`Compassionate Cancer Centre Medical Group
`Mission Hills, California, United States, 91345
`Facey Medical Group
`Riverside, California, United States, 92501
`Compassionate Cancer Care Medical Group
`Ohio Locations
`Middletown, Ohio, United States, 45042
`Signal Point Clinical Research Center, LLC
`Rhode Island Locations
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`Bristol, Rhode Island, United States, 37620
`Wellmont Medical Associates-Oncology and
`Hematology
`South Carolina Locations
`Charleston, South Carolina, United States,
`29414
`Charleston Hematology Oncology
`Utah Locations
`Ogden, Utah, United States, 84403
`Northern Utah Associates [Hematology/
`Oncology]
`Argentina
`Cordoba, Argentina, X5006HBF
`Instituto Oncológico de Córdoba (IONC)
`Córdoba, Argentina, X5004FHP
`Clínica Universitaria Reina Fabiola
`Quilmes, Argentina, B1878DVB
`Instituto Médico CER [Oncology]
`Rosario, Argentina, 2000
`Sanatorio Parque
`San Miguel de Tucuman, Argentina, T4000AIK
`Centro Medico San Roque
`Santa Fe, Argentina, 3000
`ISIS Clinica Especializada
`Buenos Aires Locations
`Mar del Plata, Buenos Aires, Argentina, 7600
`Centro Oncológico Integral (COI)
`Bulgaria
`Gabrovo, Bulgaria, 5300
`MHAT Dr. Tota Venkova
`Sofia, Bulgaria, 1233
`Specialized Hospital for Active Treatement of
`Oncology Diseases - Sofia District Medical
`Oncology Department
`Sofia, Bulgaria, 1572
`UMHAT "Tsaritsa Yoanna - ISUL" Ltd.Medical
`Oncology Clinic
`Sofia, Bulgaria, 1756
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`Specialised Hospital for Active treatment on
`Oncology
`Sofia, Bulgaria, 6300
`District Dispensery for Oncology Diseases with
`in-patient
`Stara Zagora, Bulgaria, 6003
`Complex Oncology Centre
`Croatia
`Osijek, Croatia, 31000
`Klinicki bolnicki centar [Oncology]
`Rijeka, Croatia, 51000
`KBC Rijeka
`Varazdin, Croatia, 42000
`Opca bolnica Varazdin
`Zagreb, Croatia, 10000
`KBC Zagreb
`Zagreb, Croatia, 10000
`Klinicka bolnica [Sestre milosrdnice]
`Germany
`Berlin, Germany, 10117
`Klinik und Poliklinik für Onkologie und
`Hämatologie Universitätsmedizin Charité Mitte
`Hamburg, Germany, 22081
`OncoResearch Lerchenfeld UG
`München, Germany, 81545
`Städtisches Klinikum München
`München, Germany, 81737
`Staedtisches Krankenhaus Muenchen
`Neuperlach
`Hungary
`Budapest, Hungary, 1125
`Semmelweis Egyetem Kútvölgyi Klinikai Tömb
`Budapest, Hungary, 1145
`Fővárosi Önkormányzat Uzsoki utcai Kórház
`Györ, Hungary, 9024
`Petz Aladár Megyei Oktató Kórház
`Kecskemet, Hungary, 6000
`Bács-Kiskun Megyei Önkormányzat Kórháza,
`Szeged
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`Pécs, Hungary, 7624
`Pécsi Tudományegyetem [Onkoterápiás Intézet]
`Szolnok, Hungary, 5004
`Jasz-Nagykun-Szolnok Megyei Hetenyi Geza
`Korhaz
`India
`Bangalore, India, 560068
`Sri Venkateshwara Hospital [Medical Oncology]
`Bangalore, India, 632004
`Chinmaya Mission Hospital
`Vijayawada, India, 520002
`City Cancer Centre [Surgical and Medical
`Oncology]
`Andhra Pradesh Locations
`Hyderabad, Andhra Pradesh, India, 500 082
`Yashoda Super speciality Hospital
`Maharashtra Locations
`Pune, Maharashtra, India, 444605
`Sujan Surgical Cancer Hospital and Amracvati
`Cancer Foundation
`Tamil Nadu Locations
`Chennai, Tamil Nadu, India, 600035
`Apollo Speciality Hospital
`Italy
`Brescia, Italy, 25124
`Fondazione Poliambulanza Istituto Ospedaliero
`Lecce, Italy, 73100
`Ospedale Vito Fazzi - ASL Lecce
`Lecco, Italy, 23900
`Presidio Ospedaliero "Alessandro Manzoni"
`Potenza, Italy, 85100
`AO Regionale S.Carlo di Potenza
`Poland
`Elblag, Poland, 82-300
`Szpital Wojewodzki Zespolony
`Lodz, Poland, 93-509
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`Wojewodzki Szpital Specjalistyczny im.
`M.Kopernika
`Lomza, Poland, 18-400
`Szpital Wojewodzki w Lomzy im. Kardynala S.
`Wyszynskiego
`Slupsk, Poland, 76-200
`Wojewodzki Szpital Specjalistyczny im. J.
`Korczaka
`Warszawa, Poland, 02-781
`Centrum Onkologii - Instytut im. Marii
`Sklodowskiej - Curie
`Warszawa, Poland, 04-125
`NZOZ Magodent - Centrum Medczyne
`Ostrobramska
`Romania
`Baia-Mare, Romania, 430031
`Spitalul Judetean de Urgenta "Dr. Constantin
`Opris"
`Bucharest, Romania, 22328
`Institutul Oncologic "Prof. Dr. Alex. Trestioreanu"
`Cluj-Napoca, Romania, 400015
`Institutul Oncologic "Prof. Dr. Ion Chiricuta"
`Cluj-Napoca, Romania, 400349
`Spitalul Clinic Judetean de Urgenta Cluj
`(Oncologie Medicala)
`Iasi, Romania, 700106
`Centrul de Oncologie Euroclinic
`Iasi, Romania, 700483
`Institutul Regional de Oncologie Iasi
`Sibiu, Romania, 550245
`Spitalul Clinic Judetean de Urgenta Sibiu
`[Oncologie]
`Timisoara, Romania, 300239
`Oncomed SRL
`Russian Federation
`Arkhangelsk, Russian Federation, 163045
`GUZ Arkhangelsk Regional Clinical Oncological
`Dispensary
`Krasnoyarsk, Russian Federation, 660022
`GOU VPO Krasnoyarsk State Medical University
`n.a. prof. V.F.
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`Lipetsk, Russian Federation, 398005
`GUZ Lipetsk Regional Oncology Dispensary
`[General Oncology]
`Magnitogorsk, Russian Federation, 455001
`GUZ Regional Oncology Dispensary #2
`Moscow, Russian Federation, 115478
`RAMN - Russian Cancer Research Center
`Moscow, Russian Federation, 115478
`Russian Oncology Research Center n.a. N.N.
`Blokhin RAMN
`Novosibirsk, Russian Federation, 630047
`MBUZ City Clinical Hospital #1 [Oncology]
`Obninsk, Russian Federation, 249036
`FGBU "Medical Radiology Scientific Center of
`Minzdravsotsrazvitiya RF
`Ryazan, Russian Federation, 390026
`Ryazan State Med. Univer. n.a. I.I.Pavlov based
`Ryazan Regio
`Saint Petersburg, Russian Federation, 188663
`GUZ Leningrad Regional Oncological Dispensary
`Saint Petersburg, Russian Federation, 197022
`St. Petersburg Clinical Oncology Dispesary
`Ukraine
`Chernihiv, Ukraine, 14029
`Komunalnyi likuvalno-profilaktychnyi zaklad
`"Chernigivskyi
`Dnipropetrovsk, Ukraine, 49102
`Komunalnyi zaklad Miska bahatoprofilna
`klinichna likarnia #4
`Donetsk, Ukraine, 83092
`Komunalno-klinichnyi likuvalno-profilaktychnyi
`zaklad
`Kharkiv, Ukraine, 61024
`DU IMR AMNU [vd khemter]
`Kharkiv, Ukraine, 61070
`Kharkivskyi oblasnyi onkologichnyi klinichnyi
`tsentr
`Khmelnytskyi, Ukraine, 29009
`Chmelnytskyi Regional Clinical Oncology Centre
`[Oncology]
`Uzhgorod, Ukraine, 88000
`Uzhgorod National University
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`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:
`Naïve to cytotoxic chemotherapy. Previous biological or hormonal therapy is permitted.
`Diagnosed with a malignant solid tumor and scheduled to receive first course of cytotoxic
`chemotherapy with cisplatin administered as a single I.V. dose of equal or more than 70
`mg/m2 over 1-4 hours on study Day 1, either alone or in combination with other
`chemotherapeutic agents.
`If scheduled to receive combination regimens, non-cisplatin agents of moderate to high
`emetogenic potential are allowed and they must be administered following the cisplatin
`infusion and completed no more than 6 hours after the initiation of cisplatin infusion.
`If scheduled to receive chemotherapy agents of minimal to low emetogenic potential, they
`are to be given on Day 1 following cisplatin 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 highly emetogenic cisplatin-
`based regimen based on laboratory criteria (Neutrophils,Platelets, Bilirubin, Liver enzymes,
`Serum Creatinine or Creatinine Clearance)
`If a patient has a known hepatic or renal impairment, he/she may be enrolled in this study at
`the discretion of the Investigator.
`If a patient has a known history or predisposition to cardiac conduction interval
`abnormalities he/she may be enrolled in this study at the discretion of the Investigator.
`Exclusion Criteria:
`If female, pregnant or lactating.
`Current use of illicit drugs or current evidence of alcohol abuse.
`Scheduled to receive moderately emetogenic chemotherapy (MEC) or HEC from Day 2 to
`Day 5 following cisplatin administration.
`Received or is scheduled to receive radiation therapy to the abdomen, or the pelvis within 1
`week prior to Day 1 or between Days 1 to 5.
`Any vomiting, retching, or mild nausea within 24 hours prior to Day 1.
`Symptomatic primary or metastatic CNS malignancy.
`Active peptic ulcer disease, gastrointestinal obstruction, increased intracranial pressure,
`hypercalcemia, an active infection or any uncontrolled 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.
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`Known hypersensitivity or contraindication to 5-HT3 receptor antagonists (e.g.,
`palonosetron, ondansetron, granisetron, dolasetron, tropisetron, ramosetron) or
`dexamethasone.
`Participation in a 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 study.
`Systemic corticosteroid therapy at any dose within 72 hours prior to Day 1. However topical
`and inhaled corticosteroids with a steroid dose of £ 10 mg of prednisone daily or its
`equivalent 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 Day 1
`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?
`Primary Outcome Measures
`Arms and Interventions
`Participant Group/ArmIntervention/Treatment
`Experimental: Oral
`palonosteron plus
`dexamethasone
`Oral palonosetron (Aloxi
`0.50 mg softgel
`capsule) with oral
`dexamethasone, both
`given on Day 1, prior to
`the scheduled start of
`cisplatin; then
`dexamethasone from
`Days 2 through 4.
`Drug: Oral palonosetron
`Drug: Dexamethasone
`Active Comparator: I.V.
`palonosetron plus
`dexamethasone
`Intravenous
`palonosetron (Aloxi
`0.25 mg solution for
`injection) with oral
`dexamethasone, both
`given on Day 1, prior to
`the scheduled start of
`cisplatin; then
`dexamethasone from
`Days 2 through 4.
`Drug: I.V. palonosetron
`Drug: Dexamethasone
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`Secondary Outcome Measures
`Collaborators and Investigators
`This is where you will find people and organizations involved with this study.
`Helsinn Healthcare SA
`Outcome
`Measure Measure Description Time
`Frame
`Percentage of
`Patients With
`Complete
`Response (CR)
`Defined as no
`Emesis, no
`Rescue
`Medication
`0-24
`hours
`Outcome
`Measure Measure Description Time
`Frame
`Percentage of
`Patients With
`no Emesis
`0-24
`hours
`Percentage of
`Patients With
`no Rescue
`Medication
`0-24
`hours
`Sponsor
`Collaborators
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`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
`2011-05-30
`First Submitted that Met QC Criteria
`2011-05-31
`First Posted (Estimated)
`2011-06-01
`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)
`2013-01-28
`Study Record Updates
`Last Update Submitted that met QC Criteria
`Parexel
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`2021-08-30
`Last Update Posted
`2021-09-22
`Last Verified
`2021-08
`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
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