AzTrials
AzTrials

Chemotherapy-Induced Nausea and VomitingPhase 3NCT01339260

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

A Phase 3 study testing Netupitant and Palonosetron, Palonosetron and Dexamethasone in people with Chemotherapy-Induced Nausea and Vomiting, run by Helsinn Healthcare SA at 172 sites in 15 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chemotherapy-Induced Nausea and Vomiting
What is being tested?
Netupitant and Palonosetron, Palonosetron and Dexamethasone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,455 participants
Where
172 sitesin 15 countries
Study dates
Apr 2011to Nov 2012
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
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  • 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

Who cannot join

  • 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.
Show all 27Show fewer
  • 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.

Trial locations and contacts

172 sites in 15 countries.

172 sites in 15 countries

United States28 sites

  • Anniston Oncology/Regional Medical Center

    Anniston, Alabama, 36207

  • Palm Beach Institute of Hematology and Oncology

    Boynton Beach, Florida, 33435

  • Wellmont Medical Associates-Oncology and Hematology

    Bristol, Tennessee, 37620

  • Charleston Cancer Center

    Charleston, South Carolina, 29406

  • Charleston Hematology Oncology

    Charleston, South Carolina, 29414

  • Compassionate Cancer Care Medical Group Inc

    Corona, California, 92879

  • Cancer Specialists of South Texas, P.A.

    Corpus Christi, Texas, 78412

  • Denver Health and Hospital Authority

    Denver, Colorado, 80204

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Deaconess Clinic Downtown

    Evansville, Indiana, 47713

  • Compassionate Cancer Centre Medical Group

    Fountain Valley, California, 92708

  • The John R Marsh Cancer Center

    Hagerstown, Maryland, 21742

  • Kentucky Cancer Clinic

    Hazard, Kentucky, 41701

  • Genesis Cancer Centre

    Hot Springs, Arkansas, 71913

  • Baptist Cancer Institute

    Jacksonville, Florida, 32207

  • American Institute of Research

    Los Angeles, California, 90017

  • Tri-County Hematology and Oncolgy Associates Inc.

    Massillon, Ohio, 44646

  • Signal Point Clinical Research Center LLC

    Middletown, Ohio, 45042

  • Facey Medical Group

    Mission Hills, California, 91345

  • Northwest Alabama Cancer Center

    Muscle Shoals, Alabama, 35661

  • Floyd Memorial Cancer Center of Indiana

    New Albany, Indiana, 47150

  • Northern Utah Associates Hematology / Oncology

    Ogden, Utah, 84403

  • Compassionate Cancer Care Medical Group

    Riverside, California, 92501

  • Northwest Medical Specialties

    Tacoma, Washington, 98405

  • The University of Texas Health Center

    Tyler, Texas, 75708

  • American Institute of Research

    Whittier, California, 90603

  • Piedmont Hematology Oncology Associates PA

    Winston-Salem, North Carolina, 27103

  • Fallon Clinic at Worcester Medical Center

    Worcester, Massachusetts, 01608

Other trials in United States

Russia22 sites

  • GUZ Arkhangelsk Regional Clinical Oncological Dispensary

    Arkhangelsk, 163045

  • Ivanovo Regional Oncological Dispensary [Chemotherapy]

    Ivanovo, 153013

  • GAUZ Republic Clinical Oncology Dispensary of Ministry of Health of Republic Tatarstan

    Kazan', 420029

  • GOU VPO Krasnoyarsk State Medical University n.a. prof. V.F.

    Krasnoyarsk, 660133

  • GUZ Lipetsk Regional Oncology Dispensary [General Oncology]

    Lipetsk, 398005

  • GUZ Regional Oncology Dispensary #2

    Magnitogorsk, 455001

  • Russian Cancer Research Center

    Moscow, 115478

  • SBHI of Moscow City Oncology Clinical Hospital #62

    Moscow, 143423

  • MBUZ City Clinical Hospital #1

    Novosibirsk, 630047

  • FGBU Medical Radiology Scientific Center

    Obninsk, 249036

  • GUZ Perm Regional Oncology Dispensary

    Perm, 614066

  • GUZ Pyatigorsk Oncology Dispensary [Outpatient Department]

    Pyatigorsk, 357502

  • GOU VPO - Ryazan State Med. Univer. n.a. I.I.Pavlov based Ryazan Regio

    Ryazan, 390026

  • GUZ "Leningrad Regional Oncology Dispensary"

    Saint Petersburg, 188663

  • City Oncology Dispensary

    Saint Petersburg, 197022

  • GOU VPO Saint-Petersburg State Medical University n.a. acad.

    Saint Petersburg, 197022

  • St. Petersburg Clinical Oncology Dispesary - 3rd Gynecology D

    Saint Petersburg, 197022

  • FGU Research Institute of Oncology n.a. N.N.Petrov of Rosmed

    Saint Petersburg, 197758

  • GUZ Samara Regional Clinical Oncology Dispensary

    Samara, 443031

  • Stavropol Regional Clinical Oncology Dispensary

    Stavropol, 355047

  • GBUZ - Clinical Oncology Dispensary of MoH of Republic Bahkortostan

    Ufa, 450054

  • GUZ Republican Clinical Oncological Dispensary of public

    Ufa, 450054

Other trials in Russia

India13 sites

  • HCG - Multy Speciality Hospital

    Ahmedabad, 380006

  • Hemato-Oncology Clinic Ahmedabad Pvt Ltd

    Ahmedabad, 380009

  • Sujan Surgical Cancer Hospital and Amracvati Cancer Foundation

    Amravati, 444606

  • Sri Venkateshwara Hospital [Medical Oncology]

    Bangalore, 560068

  • Apollo Speciality Hospital

    Chennai, 600035

  • Dr. Kamahshi Memorial Hospital [Oncology]

    Chennai, 600100

  • BIBI General Hospital & Cancer Centre [Oncology]

    Hyderabad, 500 024

  • Yashoda B-Block Hospital

    Hyderabad, 500 082

  • B.P.Poddar Hospital and Medical Research Ltd

    Kolkata, 700053

  • Apollo Gleneagles Hospitals Kolkata

    Kolkata, 700054

  • Shatabdhi Superspeciality Hospital

    Nashik, 422005

  • Grant Medical Foundation - Ruby Hall Clinic

    Pune, 411001

  • City Cancer Centre [Surgical and Medical Oncology]

    Vijayawada, 520002

Other trials in India

Brazil12 sites

  • OXION-Medicina Oncológica

    Belo Horizonte, 30150270

  • Centro de Pesquisas Clínicas em Oncologia

    Cachoeiro de Itapemirim, 29308-014

  • IPCEM - Centro de Ciências da Saúde - Universidade de Caxias

    Caxias do Sul, 95070-560

  • Hospital Araújo Jorge

    Goiânia, 74605-070

  • Clinica de Neoplasias do Litoral

    ItajaÃ, 88301-220

  • Clinica De Oncologia De Porto Alegre S S Ltda

    Porto Alegre, 90430-090

  • Hospital Moinhos de Vento

    Porto Alegre, RS90560-030

  • Instituto Ribeirãopretano de Combate ao Cancer

    Ribeirão Preto, 14015-130

  • Oncotrat Oncologia Medica Ltda [Oncology]

    Rio de Janeiro, 22451010

  • Nucleo de Oncologia da Bahia

    Salvador Bahia, 40170-110

  • Hospital Santa Cruz

    São Paulo, 04121-000

  • Casa de Saude Santa Marcelina

    São Paulo, 08270-070

Other trials in Brazil

Bulgaria12 sites

  • SHATO "Sveti Mina"

    Blagoevgrad, 2700

  • MHAT Dr. Tota Venkova [Oncology]

    Gabrovo, 5300

  • Specialized Hospital for Active Treatment of Oncology

    Haskovo, 6300

  • UMHAT ""Dr. Georgi Stranski"" Dept. Medical Oncology

    Pleven, 5800

  • UMHAT "Sveti Georgi" [Clinic of Oncology and Hematology]

    Plovdiv, 4002

  • District Dispensery with Stationary - Sofia District

    Sofia, 1233

  • UMHAT "Tsaritsa Yoanna - ISUL" Ltd.Medical Oncology Clinic

    Sofia, 1527

  • Specialized Hospital for Active Treatment in Oncology

    Sofia, 1756

  • Specialized Hospital for Active Treatment of Onclogy Diseases - Sofia City

    Sofia, 1784

  • Complex Oncology Centre

    Stara Zagora, 6003

  • COC - Veliko Tarnovo Dept. Medical Oncology

    Veliko Tarnovo, 5000

  • Comprehensive Cancer Center - Vratsa Dept. of Palliative Care

    Vratsa, 3000

Other trials in Bulgaria

Ukraine12 sites

  • Komunalnyi "Cherkaskyi oblasnyi onkolohichnyi dyspanser" Cherkaskoi oblasnoi rady, oblasnyi onkokhimioterapevtychnyi tsentr, m. Cherkasy

    Cherkasy, 18009

  • Komunalnyi likuvalno-profilaktychnyi zaklad "Chernigivskyi

    Chernihiv, 14029

  • Chmelnytskyi Regional Clinical Oncology Centre [Oncology]

    Chmelnytskyi, 29009

  • Komunalnyizaklad Miska bahatoprofilna klinichna likarnia #4

    Dnipropetrovks, 49102

  • Donetskyi oblasnyi protypukhlynnyi tsentr

    Donetsk, 83092

  • Kharkivskyi oblasnyi onkologichnyi klinichnyi tsentr

    Kharkiv, 61070

  • Kyirskyi Miskyi klinichnyi onkolohichnyi tsentr

    Kyiv, 03115

  • KZ KOR Kyivskyi oblasnyi onkologichnyi dyspanser

    Kyiv, 04107

  • Lvivskyi derzhavnyi onkologichnyi regionalnyi likuvalno diahnostychyi tsentr

    Lviv, 79031

  • Odeska oblasna klinichna likarnia

    Odesa, 65025

  • Poltavskyi oblasnyi klinichnyi onkolohichnyi dyspanser Pol

    Poltava, 36011

  • Zakarpatskyi oblasnyi klinichnyi onkodyspanser

    Uzhhorod, 88014

Other trials in Ukraine

Germany11 sites

  • Klinik und Poliklinik für Onkologie und Hämatologie Universitatsmedizin Charite Mitte

    Berlin, 10117

  • Gynäkologische Arztpraxis

    Berlin, 10317

  • OncoResearch Lerchenfeld UG

    Hamburg, 22081

  • Schwerpktprxs gynäkolog Onkologie Prof. Dr. Diel, Dr. Gebert

    Mannheim, 68161

  • Rotkreuzklinikum [München]

    München, 80637

  • Tumorzentrum Munchen Sued - Städtisches Klinikum [Hämato-, Onkologie + Palliativmed]

    München, 81545

  • Staedtisches Krankenhaus Muenchen Neuperlach

    München, 81737

  • OncoPRO GbR Dr. R. Dengler, Dr. A. Kröber Gesellschaft für klinische Studien in der ambulanten Hämatologie und Onkologie

    Regensburg, 93053

  • Universitätsklinikum Tübingen

    Tübingen, 72076

  • Praxis Dr. G. Dresemann

    Velen, 46342

  • Onkologische Gemeinschaftspraxis Dr. med M. Perker / PF Dr. med M. Sandherr

    Weilheim, 82362

Other trials in Germany

Poland10 sites

  • Bialostockie Centrum Onkologii im. M.Sklodowskiej-Curie

    Bialystok, 15-027

  • Wojewodzki Szpital Zespolony w Elblagu, Oddzial Onkologiczny

    Elblag, 82-200

  • Niepubliczny Specjalist. Onkol. Zaklad Opieki Zdrowotnej

    Kościerzyna, 83-400

  • Wojewodzki Szpital Specjalistyczny im. M.Kopernika

    Lodz, 93-513

  • Szpital Wojewodzki w Lomzy im. Kardynala S. Wyszynskiego

    Łomża, 18-400

  • Olsztynski Osrodek Onkologiczny "KOPERNIK"

    Olsztyn, 10-513

  • Szpital Rejonowy im. dr J. Rostka w Raciborzu

    Racibórz, 47-400

  • Wojewodzki Szpital Specjalistyczny im. J. Korczaka

    Słupsk, 76-200

  • Centrum Onkologii - Instytut im. Marii Sklodowskiej - Curie

    Warsaw, 02-781

  • NZOZ Magodent - Centrum Medczyne Ostrobramska

    Warsaw, 04-125

Other trials in Poland

Romania10 sites

  • Spitalul Judetean de Urgenta "Dr. Constantin Opris" Baia-Mare [Oncologie Medicala]

    Baia Mare, 430031

  • Spitalul Universitar de Urgenta Elias [Oncologie Medicala]

    Bucharest, 011461

  • Spitalul Clinic CF nr.2 Bucuresti [Oncologie Medicala]

    Bucharest, 011464

  • Spitalul Universitar de Urgenta Bucuresti

    Bucharest, 050098

  • Institutul Oncologic "Prof. Dr. Alex. Trestioreanu" [Sectia Clinica Radioterapie II]

    Bucharest, 22328

  • Oncolab - Oncology Center Craiova

    Craiova, 200385

  • Institutul Regional de Oncologia

    Iași, 700483

  • Spitalul Municipal Onesti [Sectia Oncologie Medicala]

    Onești, 601048

  • Spitalul Clinic Judetean Mures

    Tg Mures, 0540142

  • Oncomed SRL

    Timișoara, 300239

Other trials in Romania

Argentina9 sites

  • Hospital Italiano de Cordoba

    Córdoba, 5000

  • Clínica Universitaria Reina Fabiola (Universidad Católica de Córdoba)

    Córdoba, X5004FHP

  • Instituto Oncológico de Córdoba - Sanatorio Aconcagua

    Córdoba, X5006HBF

  • Centro Oncológico Integral (COI)

    Mar del Plata, 7600

  • Centro Oncologico de Integracion Regional (COIR)

    Mendoza, M5500AYB

  • Instituto Médico CER [Oncology]

    Quilmes, B1878DVB

  • Sanatorio Parque

    Rosario, S2000DVS

  • Centro Medico San Roque

    San Miguel de Tucumán, T4000AIK

  • ISIS Clinica Especializada

    Santa Fe, 3000

Other trials in Argentina

Croatia9 sites

  • Županijska bolnica Cakovec

    Čakovec, 40000

  • Klinicki bolnicki centar Osijek [Oncology]

    Osijek, 31000

  • Opca bolnica Pula [Odjel za onklologiju]

    Pula, 52000

  • KBC Rijeka [Gastroenterology]

    Rijeka, 51000

  • Opca bolnica Varazdin [Odjel za hem.onko i klin.imun.]

    Varaždin, 42 000

  • Opca Bolnica Zadal Ulica

    Zadar, 23000

  • Klinički bolnički centar Zagreb [Oncology]

    Zagreb, 10 000

  • Klinicka bolnica [Sestre milosrdnice]

    Zagreb, 10000

  • Klinika za tumore [Odjel za kemoter. i internisticku onkolog

    Zagreb, 10000

Other trials in Croatia

Hungary8 sites

  • Semmelweis Egyetem Kútvölgyi Klinikai Tömb

    Budapest, 1125

  • Fővárosi Önkormányzat Uzsoki utcai Kórház

    Budapest, 1145

  • Petz Aladár Megyei Oktató Kórház [Onkoradiológiai Oszt

    Győr, 9024

  • Bács-Kiskun Megyei Önkormányzat Kórháza, Szegedi

    Kecskemét, 6000

  • Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház

    Miskolc, 3526

  • Josa Andras Oktato Korhaz [Onkologiai Osztaly]

    Nyíregyháza, 4400

  • Pécsi Tudományegyetem Klinikai Köpont

    Pécs, 7624

  • Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz

    Szolnok, 5004

Other trials in Hungary

Belarus6 sites

  • Bobruisk Interregional Oncological Dispensary

    Babruysk, 213825

  • Brest Regional Oncological Dispensary

    Brest, 224027

  • Gomel Regional Clinical Oncological Dispensary

    Brest, 246012

  • Minsk city Clinical Oncological Dispensary [Oncology]

    Minsk, 220013

  • State institution N.N. Alexandrov Republican Scientific and Practical Center of Oncology and Medical Radiology

    Minsk, 223040

  • Mogilev Regional Oncological Dispensary [Oncology]

    Mogilev, 212018

Other trials in Belarus

Italy5 sites

  • Fondazione Poliambulanza Istituto Ospedaliero

    Brescia, 25124

  • Ospedale Vito Fazzi, ASL Lecce

    Lecce, 73100

  • Presidio Ospedaliero "Alessandro Manzoni", AO Provincia di Lecco

    Lecco, 23900

  • Ospedale Sacro Cuore e Don Calabria - Negrar

    Negrar, 37024

  • Ospedale S.Carlo di Potenza [U.O. di Oncologia Medica]

    Potenza, 85100

Other trials in Italy

Mexico5 sites

  • Centro Oncologico De Chihuahua

    Chihuahua City, 31217

  • Hospital de Jesus

    México, 06090

  • Centro Medico Quirurgico

    México, 20234

  • OCA Hospital/Monterrey International Research Center

    Monterrey, 64000

  • Centro Regiomontano de Investigación Clínica

    Monterrey, 64710

Other trials in Mexico

About this study

Official title: 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.

Read the 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).

Being tested
Netupitant and Palonosetron, Palonosetron, Dexamethasone
Medical subject headings
Vomiting

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01339260
Study groupRoleWhat they receive
Netupitant and Palonosetron+dexamethasone-cycle 1ExperimentalOral 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
Receives: Drug: Netupitant and Palonosetron; Drug: Dexamethasone
Palonosetron+dexamethasone-cycle 1Active comparatorOral palonosetron 0.50 mg (Aloxi) with oral dexamethasone (20 mg) both given on Day 1, prior to each scheduled chemotherapy cycle
Receives: Drug: Palonosetron; Drug: Dexamethasone
Netupitant and Palonosetron+dexamethasone-multicycle extensionExperimentalOral 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
Receives: Drug: Netupitant and Palonosetron; Drug: Dexamethasone
Palonosetron+dexamethasone-multicycle extensionActive comparatorOral palonosetron 0.50 mg (Aloxi) with oral dexamethasone (20 mg) both given on Day 1, prior to each scheduled chemotherapy cycle
Receives: Drug: Palonosetron; Drug: Dexamethasone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication, at Cycle 1

    Measured: 25-120 hours

Secondary outcomes (2)

  1. Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication at Cycle 1

    Measured: 0-24 hours

  2. Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication, at Cycle 1

    Measured: 0-120 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2011 (estimated)
  2. Study startApr 2011
  3. Primary completionNov 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,455 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01339260
Sponsor's protocol ID
NETU-08-18
Status last verified
Nov 2014
First submitted
19 Apr 2011
Last updated
26 Nov 2014
Data monitoring committee
Yes

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.

    PubMed 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 III trials. Breast. 2017 Jun;33:76-82. doi: 10.1016/j.breast.2017.02.017. Epub 2017 Mar 10.

    PubMed 28285236

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Netupitant and Palonosetron, Palonosetron and Dexamethasone in people with Chemotherapy-Induced Nausea and Vomiting, run by Helsinn Healthcare SA at 172 sites in 15 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 172 sites in United States, Russia, India, Brazil, Bulgaria and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Nov 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication, at Cycle 1 (time frame: 25-120 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01339260, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2014.

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