An Efficacy and Safety Study of Oral Netupitant and Palonosetron for the Prevention of Nausea and Vomiting

A Phase III Multicenter, Randomized, Double-blind, Double-dummy, Active-controlled, Parallel Group Study of the Efficacy and Safety of Oral Netupitant Administered in Combination With Palonosetron and Dexamethasone Compared to Oral Palonosetron and Dexamethasone for the Prevention of Nausea and Vomiting in Cancer Patients Receiving Moderately Emetogenic Chemotherapy

NETU-08-18 is a two-arm clinical study assessing efficacy and safety of a single oral dose of netupitant and palonosetron, two antiemetic drugs, versus oral palonosetron, both given with oral dexamethasone. The objective of the study is to demonstrate that netupitant and palonosetron are more effective than palonosetron alone, to prevent nausea and vomiting induced by moderately emetogenic cancer chemotherapy after administration of repeated cycles of chemotherapy.

Study Overview

• Status: Completed
• Conditions: Chemotherapy-Induced Nausea and Vomiting
• Intervention / Treatment: Drug: Dexamethasone; Drug: Palonosetron; Drug: Netupitant and Palonosetron

Detailed Description

NETU-08-18 is a two-arm clinical study assessing efficacy and safety of a single oral dose of netupitant and palonosetron, two antiemetic drugs, versus oral palonosetron, both given with oral dexamethasone. Study is organised in two phases: cycle-1 and a multi-cycle extension. Safety assessment is performed separately in cycle 1 (arm 1 and arm 2) and in multi-cycle extension (arm 3 and arm 4).

• Study Type: Interventional
• Enrollment (Actual): 1455
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Cordoba, Argentina, X5006HBF
    • Instituto Oncológico de Córdoba - Sanatorio Aconcagua
  • Córdoba, Argentina, 5000
    • Hospital Italiano de Cordoba
  • Córdoba, Argentina, X5004FHP
    • Clínica Universitaria Reina Fabiola (Universidad Católica de Córdoba)
  • Mar del Plata, Argentina, 7600
    • Centro Oncológico Integral (COI)
  • Mendoza, Argentina, M5500AYB
    • Centro Oncologico de Integracion Regional (COIR)
  • Quilmes, Argentina, B1878DVB
    • Instituto Médico CER [Oncology]
  • Rosario, Argentina, S2000DVS
    • Sanatorio Parque
  • San Miguel de Tucuman, Argentina, T4000AIK
    • Centro Medico San Roque
  • Santa Fe, Argentina, 3000
    • ISIS Clinica Especializada
• Belarus
  • Bobruisk, Belarus, 213825
    • Bobruisk Interregional Oncological Dispensary
  • Brest, Belarus, 224027
    • Brest Regional Oncological Dispensary
  • Brest, Belarus, 246012
    • Gomel Regional Clinical Oncological Dispensary
  • Minsk, Belarus, 220013
    • Minsk city Clinical Oncological Dispensary [Oncology]
  • Minsk, Belarus, 223040
    • State institution N.N. Alexandrov Republican Scientific and Practical Center of Oncology and Medical Radiology
  • Mogilev, Belarus, 212018
    • Mogilev Regional Oncological Dispensary [Oncology]
• Brazil
  • Belo Horizonte, Brazil, 30150270
    • OXION-Medicina Oncológica
  • Cachoeiro de Itapemirim, Brazil, 29308-014
    • Centro de Pesquisas Clínicas em Oncologia
  • Caxias do Sul, Brazil, 95070-560
    • IPCEM - Centro de Ciências da Saúde - Universidade de Caxias
  • Goiânia, Brazil, 74605-070
    • Hospital Araújo Jorge
  • ItajaÃ, Brazil, 88301-220
    • Clinica de Neoplasias do Litoral
  • Porto Alegre, Brazil, 90430-090
    • Clinica De Oncologia De Porto Alegre S S Ltda
  • Porto Alegre, Brazil, RS90560-030
    • Hospital Moinhos de Vento
  • Ribeirão Preto, Brazil, 14015-130
    • Instituto Ribeiraopretano de Combate Ao Cancer
  • Rio de Janeiro, Brazil, 22451010
    • Oncotrat Oncologia Medica Ltda [Oncology]
  • Salvador Bahia, Brazil, 40170-110
    • Nucleo de Oncologia da Bahia
  • São Paulo, Brazil, 04121-000
    • Hospital Santa Cruz
  • São Paulo, Brazil, 08270-070
    • Casa de Saude Santa Marcelina
• Bulgaria
  • Blagoevgrad, Bulgaria, 2700
    • SHATO "Sveti Mina"
  • Gabrovo, Bulgaria, 5300
    • MHAT Dr. Tota Venkova [Oncology]
  • Haskovo, Bulgaria, 6300
    • Specialized Hospital for Active Treatment of Oncology
  • Pleven, Bulgaria, 5800
    • UMHAT ""Dr. Georgi Stranski"" Dept. Medical Oncology
  • Plovdiv, Bulgaria, 4002
    • UMHAT "Sveti Georgi" [Clinic of Oncology and Hematology]
  • Sofia, Bulgaria, 1233
    • District Dispensery with Stationary - Sofia District
  • Sofia, Bulgaria, 1527
    • UMHAT "Tsaritsa Yoanna - ISUL" Ltd.Medical Oncology Clinic
  • Sofia, Bulgaria, 1756
    • Specialized Hospital for Active Treatment in Oncology
  • Sofia, Bulgaria, 1784
    • Specialized Hospital for Active Treatment of Onclogy Diseases - Sofia City
  • Stara Zagora, Bulgaria, 6003
    • Complex Oncology Centre
  • Veliko Tarnovo, Bulgaria, 5000
    • COC - Veliko Tarnovo Dept. Medical Oncology
  • Vratsa, Bulgaria, 3000
    • Comprehensive Cancer Center - Vratsa Dept. of Palliative Care
• Croatia
  • Cakovec, Croatia, 40000
    • Zupanijska bolnica Cakovec
  • Osijek, Croatia, 31000
    • Klinicki bolnicki centar Osijek [Oncology]
  • Pula, Croatia, 52000
    • Opca bolnica Pula [Odjel za onklologiju]
  • Rijeka, Croatia, 51000
    • KBC Rijeka [Gastroenterology]
  • Varazdin, Croatia, 42 000
    • Opca bolnica Varazdin [Odjel za hem.onko i klin.imun.]
  • Zadar, Croatia, 23000
    • Opca Bolnica Zadal Ulica
  • Zagreb, Croatia, 10000
    • Klinicka bolnica [Sestre milosrdnice]
  • Zagreb, Croatia, 10 000
    • Klinički bolnički centar Zagreb [Oncology]
  • Zagreb, Croatia, 10000
    • Klinika za tumore [Odjel za kemoter. i internisticku onkolog
• Germany
  • Berlin, Germany, 10117
    • Klinik und Poliklinik für Onkologie und Hämatologie Universitatsmedizin Charite Mitte
  • Berlin, Germany, 10317
    • Gynäkologische Arztpraxis
  • Hamburg, Germany, 22081
    • OncoResearch Lerchenfeld UG
  • Mannheim, Germany, 68161
    • Schwerpktprxs gynäkolog Onkologie Prof. Dr. Diel, Dr. Gebert
  • München, Germany, 81737
    • Staedtisches Krankenhaus Muenchen Neuperlach
  • München, Germany, 80637
    • Rotkreuzklinikum [München]
  • München, Germany, 81545
    • Tumorzentrum Munchen Sued - Städtisches Klinikum [Hämato-, Onkologie + Palliativmed]
  • Regensburg, Germany, 93053
    • OncoPRO GbR Dr. R. Dengler, Dr. A. Kröber Gesellschaft für klinische Studien in der ambulanten Hämatologie und Onkologie
  • Tübingen, Germany, 72076
    • Universitatsklinikum Tubingen
  • Velen, Germany, 46342
    • Praxis Dr. G. Dresemann
  • Weilheim, Germany, 82362
    • Onkologische Gemeinschaftspraxis Dr. med M. Perker / PF Dr. med M. Sandherr
• Hungary
  • Budapest, Hungary, 1125
    • Semmelweis Egyetem Kútvölgyi Klinikai Tömb
  • Budapest, Hungary, 1145
    • Fövárosi Önkormányzat uzsoki utcai Kórház
  • Győr, Hungary, 9024
    • Petz Aladár Megyei Oktató Kórház [Onkoradiológiai Oszt
  • Kecskemet, Hungary, 6000
    • Bács-Kiskun Megyei Önkormányzat Kórháza, Szegedi
  • Miskolc, Hungary, 3526
    • Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz
  • Nyíregyháza, Hungary, 4400
    • Josa Andras Oktato Korhaz [Onkologiai Osztaly]
  • Pécs, Hungary, 7624
    • Pécsi Tudományegyetem Klinikai Köpont
  • Szolnok, Hungary, 5004
    • Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz
• India
  • Ahmedabad, India, 380006
    • HCG - Multy Speciality Hospital
  • Ahmedabad, India, 380009
    • Hemato-Oncology Clinic Ahmedabad Pvt Ltd
  • Amravati, India, 444606
    • Sujan Surgical Cancer Hospital and Amracvati Cancer Foundation
  • Bangalore, India, 560068
    • Sri Venkateshwara Hospital [Medical Oncology]
  • Chennai, India, 600035
    • Apollo Speciality Hospital
  • Chennai, India, 600100
    • Dr. Kamahshi Memorial Hospital [Oncology]
  • Hyderabad, India, 500 024
    • BIBI General Hospital & Cancer Centre [Oncology]
  • Hyderabad, India, 500 082
    • Yashoda B-Block Hospital
  • Kolkata, India, 700053
    • B.P.Poddar Hospital and Medical Research Ltd
  • Kolkata, India, 700054
    • Apollo Gleneagles Hospitals Kolkata
  • Nashik, India, 422005
    • Shatabdhi Superspeciality Hospital
  • Pune, India, 411001
    • Grant Medical Foundation - Ruby Hall Clinic
  • Vijayawada, India, 520002
    • City Cancer Centre [Surgical and Medical Oncology]
• Italy
  • Brescia, Italy, 25124
    • Fondazione Poliambulanza Istituto Ospedaliero
  • Lecce, Italy, 73100
    • Ospedale Vito Fazzi, ASL Lecce
  • Lecco, Italy, 23900
    • Presidio Ospedaliero "Alessandro Manzoni", AO Provincia di Lecco
  • Negrar, Italy, 37024
    • Ospedale Sacro Cuore e Don Calabria - Negrar
  • Potenza, Italy, 85100
    • Ospedale S.Carlo di Potenza [U.O. di Oncologia Medica]
• Mexico
  • Chihuahua, Mexico, 31217
    • Centro Oncológico de Chihuahua
  • Mexico, Mexico, 06090
    • Hospital de Jesús
  • Mexico, Mexico, 20234
    • Centro Medico Quirurgico
  • Monterrey, Mexico, 64000
    • OCA Hospital/Monterrey International Research Center
  • Monterrey, Mexico, 64710
    • Centro Regiomontano de Investigación Clínica
• Poland
  • Bialystok, Poland, 15-027
    • Bialostockie Centrum Onkologii im. M.Sklodowskiej-Curie
  • Elblag, Poland, 82-200
    • Wojewodzki Szpital Zespolony w Elblagu, Oddzial Onkologiczny
  • Koscierzyna, Poland, 83-400
    • Niepubliczny Specjalist. Onkol. Zaklad Opieki Zdrowotnej
  • Lodz, Poland, 93-513
    • Wojewodzki Szpital Specjalistyczny im. M.Kopernika
  • Lomza, Poland, 18-400
    • Szpital Wojewodzki w Lomzy im. Kardynala S. Wyszynskiego
  • Olsztyn, Poland, 10-513
    • Olsztynski Osrodek Onkologiczny "Kopernik"
  • Raciborz, Poland, 47-400
    • Szpital Rejonowy im. dr J. Rostka w Raciborzu
  • 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" Baia-Mare [Oncologie Medicala]
  • Bucuresti, Romania, 050098
    • Spitalul Universitar de Urgenta Bucuresti
  • Bucuresti, Romania, 011461
    • Spitalul Universitar de Urgenta Elias [Oncologie Medicala]
  • Bucuresti, Romania, 011464
    • Spitalul Clinic CF nr.2 Bucuresti [Oncologie Medicala]
  • Bucuresti, Romania, 22328
    • Institutul Oncologic "Prof. Dr. Alex. Trestioreanu" [Sectia Clinica Radioterapie II]
  • Craiova, Romania, 200385
    • Oncolab - Oncology Center Craiova
  • Iasi, Romania, 700483
    • Institutul Regional de Oncologia
  • Onesti, Romania, 601048
    • Spitalul Municipal Onesti [Sectia Oncologie Medicala]
  • Tg Mures, Romania, 0540142
    • Spitalul Clinic Judetean Mures
  • Timisoara, Romania, 300239
    • Oncomed Srl
• Russian Federation
  • Arkhangelsk, Russian Federation, 163045
    • GUZ Arkhangelsk Regional Clinical Oncological Dispensary
  • Ivanovo, Russian Federation, 153013
    • Ivanovo Regional Oncological Dispensary [Chemotherapy]
  • Kazan, Russian Federation, 420029
    • GAUZ Republic Clinical Oncology Dispensary of Ministry of Health of Republic Tatarstan
  • Krasnoyarsk, Russian Federation, 660133
    • GOU VPO Krasnoyarsk State Medical University n.a. prof. V.F.
  • Lipetsk, Russian Federation, 398005
    • GUZ Lipetsk Regional Oncology Dispensary [General Oncology]
  • Magnitogorsk, Russian Federation, 455001
    • GUZ Regional Oncology Dispensary #2
  • Moscow, Russian Federation, 115478
    • Russian Cancer Research Center
  • Moscow, Russian Federation, 143423
    • SBHI of Moscow City Oncology Clinical Hospital #62
  • Novosibirsk, Russian Federation, 630047
    • MBUZ City Clinical Hospital #1
  • Obninsk, Russian Federation, 249036
    • FGBU Medical Radiology Scientific Center
  • Perm, Russian Federation, 614066
    • GUZ Perm Regional Oncology Dispensary
  • Pyatigorsk, Russian Federation, 357502
    • GUZ Pyatigorsk Oncology Dispensary [Outpatient Department]
  • Ryazan, Russian Federation, 390026
    • GOU VPO - Ryazan State Med. Univer. n.a. I.I.Pavlov based Ryazan Regio
  • Saint Petersburg, Russian Federation, 197022
    • City Oncology Dispensary
  • Saint Petersburg, Russian Federation, 197022
    • GOU VPO Saint-Petersburg State Medical University n.a. acad.
  • Saint Petersburg, Russian Federation, 197022
    • St. Petersburg Clinical Oncology Dispesary - 3rd Gynecology D
  • Saint-Petersburg, Russian Federation, 188663
    • GUZ "Leningrad Regional Oncology Dispensary"
  • Samara, Russian Federation, 443031
    • GUZ Samara Regional Clinical Oncology Dispensary
  • St. Petersburg, Russian Federation, 197758
    • FGU Research Institute of Oncology n.a. N.N.Petrov of Rosmed
  • Stavropol, Russian Federation, 355047
    • Stavropol Regional Clinical Oncology Dispensary
  • Ufa, Russian Federation, 450054
    • GBUZ - Clinical Oncology Dispensary of MoH of Republic Bahkortostan
  • Ufa, Russian Federation, 450054
    • GUZ Republican Clinical Oncological Dispensary of public
• Ukraine
  • Cherkasy, Ukraine, 18009
    • Komunalnyi "Cherkaskyi oblasnyi onkolohichnyi dyspanser" Cherkaskoi oblasnoi rady, oblasnyi onkokhimioterapevtychnyi tsentr, m. Cherkasy
  • Chernigiv, Ukraine, 14029
    • Komunalnyi likuvalno-profilaktychnyi zaklad "Chernigivskyi
  • Chmelnytskyi, Ukraine, 29009
    • Chmelnytskyi Regional Clinical Oncology Centre [Oncology]
  • Dnipropetrovks, Ukraine, 49102
    • Komunalnyizaklad Miska bahatoprofilna klinichna likarnia #4
  • Donetsk, Ukraine, 83092
    • Donetskyi oblasnyi protypukhlynnyi tsentr
  • Kharkiv, Ukraine, 61070
    • Kharkivskyi oblasnyi onkologichnyi klinichnyi tsentr
  • Kyiv, Ukraine, 03115
    • Kyirskyi Miskyi klinichnyi onkolohichnyi tsentr
  • Kyiv, Ukraine, 04107
    • KZ KOR Kyivskyi oblasnyi onkologichnyi dyspanser
  • Lviv, Ukraine, 79031
    • Lvivskyi derzhavnyi onkologichnyi regionalnyi likuvalno diahnostychyi tsentr
  • Odessa, Ukraine, 65025
    • Odeska oblasna klinichna likarnia
  • Poltava, Ukraine, 36011
    • Poltavskyi oblasnyi klinichnyi onkolohichnyi dyspanser Pol
  • Uzhgorod, Ukraine, 88014
    • Zakarpatskyi oblasnyi klinichnyi onkodyspanser
• United States
  • Alabama
    • Anniston, Alabama, United States, 36207
      • Anniston Oncology/Regional Medical Center
    • Muscle Shoals, Alabama, United States, 35661
      • Northwest Alabama Cancer Center
  • Arkansas
    • Hot Springs, Arkansas, United States, 71913
      • Genesis Cancer Centre
  • California
    • Corona, California, United States, 92879
      • Compassionate Cancer Care Medical Group Inc
    • Fountain Valley, California, United States, 92708
      • Compassionate Cancer Centre Medical Group
    • Los Angeles, California, United States, 90017
      • American Institute of Research
    • Mission Hills, California, United States, 91345
      • Facey Medical Group
    • Riverside, California, United States, 92501
      • Compassionate Cancer Care Medical Group
    • Whittier, California, United States, 90603
      • American Institute of Research
  • Colorado
    • Denver, Colorado, United States, 80204
      • Denver Health and Hospital Authority
  • Florida
    • Boynton Beach, Florida, United States, 33435
      • Palm Beach Institute of Hematology and Oncology
    • Jacksonville, Florida, United States, 32207
      • Baptist Cancer Institute
  • Indiana
    • Evansville, Indiana, United States, 47713
      • Deaconess Clinic Downtown
    • New Albany, Indiana, United States, 47150
      • Floyd Memorial Cancer Center of Indiana
  • Kentucky
    • Hazard, Kentucky, United States, 41701
      • Kentucky Cancer Clinic
  • Maryland
    • Hagerstown, Maryland, United States, 21742
      • The John R Marsh Cancer Center
  • Massachusetts
    • Worcester, Massachusetts, United States, 01608
      • Fallon Clinic at Worcester Medical Center
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
    • Winston-Salem, North Carolina, United States, 27103
      • Piedmont Hematology Oncology Associates PA
  • Ohio
    • Massillon, Ohio, United States, 44646
      • Tri-County Hematology and Oncolgy Associates Inc.
    • Middletown, Ohio, United States, 45042
      • Signal Point Clinical Research Center LLC
  • South Carolina
    • Charleston, South Carolina, United States, 29406
      • Charleston Cancer Center
    • Charleston, South Carolina, United States, 29414
      • Charleston Hematology Oncology
  • Tennessee
    • Bristol, Tennessee, United States, 37620
      • Wellmont Medical Associates-Oncology and Hematology
  • Texas
    • Corpus Christi, Texas, United States, 78412
      • Cancer Specialists of South Texas, P.A.
    • Tyler, Texas, United States, 75708
      • The University of Texas Health Center
  • Utah
    • Ogden, Utah, United States, 84403
      • Northern Utah Associates Hematology / Oncology
  • Washington
    • Tacoma, Washington, United States, 98405
      • Northwest Medical Specialties

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Naïve to cytotoxic chemotherapy. Previous biological or hormonal therapy will be permitted.
• Scheduled to receive first course of an anthracycline and cyclophosphamide containing moderately emetogenic chemotherapy (MEC) regimen for the treatment of a solid malignant tumor: 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/m2) and I.V. epirubicin (more or equal to 60 mg/m2).
• If scheduled to receive chemotherapy agents of minimal to low emetogenic potential they could be given on any day.
• Eastern Cooperative Oncology Group (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)

The following inclusion criteria must be checked prior inclusion at each cycle of the Multiple-Cycle Extension:

• Participation in the study during the next cycle of chemotherapy is considered appropriate by the investigator Satisfactory study compliance in the preceding cycle of chemotherapy and related study procedures.
• Scheduled to receive the same chemotherapy regimen as cycle 1
• Adequate hematologic and metabolic status as defined for cycle 1

Exclusion Criteria:

• If female, pregnant or lactating.
• Current use of illicit drugs or current evidence of alcohol abuse.
• Scheduled to receive any highly emetogenic chemotherapy (HEC) from Day 1 to Day 5 or moderately emetogenic chemotherapy (MEC) from Day 2 to Day 5 following the allowed MEC regimen.
• 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 in cycle 1.
• Any vomiting, retching, or mild nausea within 24 hours prior to Day 1.
• Symptomatic primary or metastatic central nervous system (CNS) malignancy.
• Active peptic ulcer disease, gastrointestinal obstruction, increased intracranial pressure, hypercalcemia, an active infection or any uncontrolled medical condition (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.
• Known hypersensitivity or contraindication to 5-HT3 receptor antagonists or dexamethasone.
• Previously received a neurokin-1 (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.
• 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 of cycle 1
• Scheduled to receive any strong or moderate inhibitor of cytocrome P450 3A4 (CYP3A4) or its intake within 1 week prior to Day 1.
• Scheduled to receive any of the following CYP3A4 substrates: terfenadine, cisapride, astemizole, pimozide.
• 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, including myocardial infarction within 3 months prior to Day 1, unstable angina pectoris, significant valvular or pericardial disease, history of ventricular tachycardia, symptomatic Congestive Heart Failure (CHF) New York Heart Association (NYHA) class III-IV, 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.

The following exclusion criteria must be checked prior inclusion at each cycle of the Multiple-Cycle Extension:

• If female, pregnant or lactating
• Active infection or uncontrolled disease except for malignancy.
• Started any of the restricted medications.
• Any vomiting, retching, or mild nausea within 24 hours prior to Day 1.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Netupitant and Palonosetron+dexamethasone-cycle 1; Oral netupitant/palonosetron (300 mg/0.50 mg) hard capsule with oral dexamethasone (12 mg), both given on Day 1, prior to each scheduled chemotherapy cycle	Drug: Dexamethasone; Drug: Netupitant and Palonosetron
Active Comparator: Palonosetron+dexamethasone-cycle 1; Oral palonosetron 0.50 mg (Aloxi) with oral dexamethasone (20 mg) both given on Day 1, prior to each scheduled chemotherapy cycle	Drug: Dexamethasone; Drug: Palonosetron
Experimental: Netupitant and Palonosetron+dexamethasone-multicycle extension; Oral netupitant/palonosetron (300 mg/0.50 mg) hard capsule with oral dexamethasone (12 mg), both given on Day 1, prior to each scheduled chemotherapy cycle	Drug: Dexamethasone; Drug: Netupitant and Palonosetron
Active Comparator: Palonosetron+dexamethasone-multicycle extension; Oral palonosetron 0.50 mg (Aloxi) with oral dexamethasone (20 mg) both given on Day 1, prior to each scheduled chemotherapy cycle	Drug: Dexamethasone; Drug: Palonosetron

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication, at Cycle 1	25-120 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication at Cycle 1	0-24 hours
Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication, at Cycle 1	0-120 hours

Collaborators and Investigators

• Sponsor: Helsinn Healthcare SA
• Collaborators: Parexel

Publications and helpful links

General Publications

• 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 III studies. Cancer Med. 2019 May;8(5):2064-2073. doi: 10.1002/cam4.2091. Epub 2019 Apr 9.
• 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 III trials. Breast. 2017 Jun;33:76-82. doi: 10.1016/j.breast.2017.02.017. Epub 2017 Mar 10.

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Actual): November 1, 2012

Study Registration Dates

• First Submitted: April 19, 2011
• First Submitted That Met QC Criteria: April 19, 2011
• First Posted (Estimate): April 20, 2011

Study Record Updates

• Last Update Posted (Estimate): November 26, 2014
• Last Update Submitted That Met QC Criteria: November 19, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Nausea; Vomiting; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Serotonin Agents; Serotonin Antagonists; Serotonin 5-HT3 Receptor Antagonists; Dexamethasone; Palonosetron
• Other Study ID Numbers: NETU-08-18