Clinical trial NCT01339260: An Efficacy and Safety Study of Oral Netupitant and Palonosetron for the Prevention of Nausea and Vomiting
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chemotherapy-Induced Nausea and Vomiting
Lead sponsor: Helsinn Healthcare SA
Sponsor class: INDUSTRY
Collaborators: name: Parexel
First posted: 2011-04-20
Enrollment: 1455
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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. 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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication, at Cycle 1
timeFrame: 25-120 hours
Secondary outcomes:
measure: Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication at Cycle 1
timeFrame: 0-24 hours
measure: Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication, at Cycle 1
timeFrame: 0-120 hours
Other outcomes:
Locations:
city: Anniston
country: United States
facility: Anniston Oncology/Regional Medical Center
state: Alabama
city: Muscle Shoals
country: United States
facility: Northwest Alabama Cancer Center
state: Alabama
city: Hot Springs
country: United States
facility: Genesis Cancer Centre
state: Arkansas
city: Corona
country: United States
facility: Compassionate Cancer Care Medical Group Inc
state: California
city: Fountain Valley
country: United States
facility: Compassionate Cancer Centre Medical Group
state: California
city: Los Angeles
country: United States
facility: American Institute of Research
state: California
city: Mission Hills
country: United States
facility: Facey Medical Group
state: California
city: Riverside
country: United States
facility: Compassionate Cancer Care Medical Group
state: California
city: Whittier
country: United States
facility: American Institute of Research
state: California
city: Denver
country: United States
facility: Denver Health and Hospital Authority
state: Colorado
city: Boynton Beach
country: United States
facility: Palm Beach Institute of Hematology and Oncology
state: Florida
city: Jacksonville
country: United States
facility: Baptist Cancer Institute
state: Florida
city: Evansville
country: United States
facility: Deaconess Clinic Downtown
state: Indiana
city: New Albany
country: United States
facility: Floyd Memorial Cancer Center of Indiana
state: Indiana
city: Hazard
country: United States
facility: Kentucky Cancer Clinic
state: Kentucky
city: Hagerstown
country: United States
facility: The John R Marsh Cancer Center
state: Maryland
city: Worcester
country: United States
facility: Fallon Clinic at Worcester Medical Center
state: Massachusetts
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Piedmont Hematology Oncology Associates PA
state: North Carolina
city: Massillon
country: United States
facility: Tri-County Hematology and Oncolgy Associates Inc.
state: Ohio
city: Middletown
country: United States
facility: Signal Point Clinical Research Center LLC
state: Ohio
city: Charleston
country: United States
facility: Charleston Cancer Center
state: South Carolina
city: Charleston
country: United States
facility: Charleston Hematology Oncology
state: South Carolina
city: Bristol
country: United States
facility: Wellmont Medical Associates-Oncology and Hematology
state: Tennessee
city: Corpus Christi
country: United States
facility: Cancer Specialists of South Texas, P.A.
state: Texas
city: Tyler
country: United States
facility: The University of Texas Health Center
state: Texas
city: Ogden
country: United States
facility: Northern Utah Associates Hematology / Oncology
state: Utah
city: Tacoma
country: United States
facility: Northwest Medical Specialties
state: Washington
city: Cordoba
country: Argentina
facility: Instituto Oncológico de Córdoba - Sanatorio Aconcagua
city: Córdoba
country: Argentina
facility: Hospital Italiano de Cordoba
city: Córdoba
country: Argentina
facility: Clínica Universitaria Reina Fabiola (Universidad Católica de Córdoba)
city: Mar del Plata
country: Argentina
facility: Centro Oncológico Integral (COI)
city: Mendoza
country: Argentina
facility: Centro Oncologico de Integracion Regional (COIR)
city: Quilmes
country: Argentina
facility: Instituto Médico CER [Oncology]
city: Rosario
country: Argentina
facility: Sanatorio Parque
city: San Miguel de Tucuman
country: Argentina
facility: Centro Medico San Roque
city: Santa Fe
country: Argentina
facility: ISIS Clinica Especializada
city: Bobruisk
country: Belarus
facility: Bobruisk Interregional Oncological Dispensary
city: Brest
country: Belarus
facility: Brest Regional Oncological Dispensary
city: Brest
country: Belarus
facility: Gomel Regional Clinical Oncological Dispensary
city: Minsk
country: Belarus
facility: Minsk city Clinical Oncological Dispensary [Oncology]
city: Minsk
country: Belarus
facility: State institution N.N. Alexandrov Republican Scientific and Practical Center of Oncology and Medical Radiology
city: Mogilev
country: Belarus
facility: Mogilev Regional Oncological Dispensary [Oncology]
city: Belo Horizonte
country: Brazil
facility: OXION-Medicina Oncológica
city: Cachoeiro de Itapemirim
country: Brazil
facility: Centro de Pesquisas Clínicas em Oncologia
city: Caxias do Sul
country: Brazil
facility: IPCEM - Centro de Ciências da Saúde - Universidade de Caxias
city: Goiânia
country: Brazil
facility: Hospital Araújo Jorge
city: ItajaÃ
country: Brazil
facility: Clinica de Neoplasias do Litoral
city: Porto Alegre
country: Brazil
facility: Clinica De Oncologia De Porto Alegre S S Ltda
city: Porto Alegre
country: Brazil
facility: Hospital Moinhos de Vento
city: Ribeirão Preto
country: Brazil
facility: Instituto Ribeirãopretano de Combate ao Cancer
city: Rio de Janeiro
country: Brazil
facility: Oncotrat Oncologia Medica Ltda [Oncology]
city: Salvador Bahia
country: Brazil
facility: Nucleo de Oncologia da Bahia
city: São Paulo
country: Brazil
facility: Hospital Santa Cruz
city: São Paulo
country: Brazil
facility: Casa de Saude Santa Marcelina
city: Blagoevgrad
country: Bulgaria
facility: SHATO "Sveti Mina"
city: Gabrovo
country: Bulgaria
facility: MHAT Dr. Tota Venkova [Oncology]
city: Haskovo
country: Bulgaria
facility: Specialized Hospital for Active Treatment of Oncology
city: Pleven
country: Bulgaria
facility: UMHAT ""Dr. Georgi Stranski"" Dept. Medical Oncology
city: Plovdiv
country: Bulgaria
facility: UMHAT "Sveti Georgi" [Clinic of Oncology and Hematology]
city: Sofia
country: Bulgaria
facility: District Dispensery with Stationary - Sofia District
city: Sofia
country: Bulgaria
facility: UMHAT "Tsaritsa Yoanna - ISUL" Ltd.Medical Oncology Clinic
city: Sofia
country: Bulgaria
facility: Specialized Hospital for Active Treatment in Oncology
city: Sofia
country: Bulgaria
facility: Specialized Hospital for Active Treatment of Onclogy Diseases - Sofia City
city: Stara Zagora
country: Bulgaria
facility: Complex Oncology Centre
city: Veliko Tarnovo
country: Bulgaria
facility: COC - Veliko Tarnovo Dept. Medical Oncology
city: Vratsa
country: Bulgaria
facility: Comprehensive Cancer Center - Vratsa Dept. of Palliative Care
city: Cakovec
country: Croatia
facility: Županijska bolnica Cakovec
city: Osijek
country: Croatia
facility: Klinicki bolnicki centar Osijek [Oncology]
city: Pula
country: Croatia
facility: Opca bolnica Pula [Odjel za onklologiju]
city: Rijeka
country: Croatia
facility: KBC Rijeka [Gastroenterology]
city: Varazdin
country: Croatia
facility: Opca bolnica Varazdin [Odjel za hem.onko i klin.imun.]
city: Zadar
country: Croatia
facility: Opca Bolnica Zadal Ulica
city: Zagreb
country: Croatia
facility: Klinički bolnički centar Zagreb [Oncology]
city: Zagreb
country: Croatia
facility: Klinicka bolnica [Sestre milosrdnice]
city: Zagreb
country: Croatia
facility: Klinika za tumore [Odjel za kemoter. i internisticku onkolog
city: Berlin
country: Germany
facility: Klinik und Poliklinik für Onkologie und Hämatologie Universitatsmedizin Charite Mitte
city: Berlin
country: Germany
facility: Gynäkologische Arztpraxis
city: Hamburg
country: Germany
facility: OncoResearch Lerchenfeld UG
city: Mannheim
country: Germany
facility: Schwerpktprxs gynäkolog Onkologie Prof. Dr. Diel, Dr. Gebert
city: München
country: Germany
facility: Rotkreuzklinikum [München]
city: München
country: Germany
facility: Tumorzentrum Munchen Sued - Städtisches Klinikum [Hämato-, Onkologie + Palliativmed]
city: München
country: Germany
facility: Staedtisches Krankenhaus Muenchen Neuperlach
city: Regensburg
country: Germany
facility: OncoPRO GbR Dr. R. Dengler, Dr. A. Kröber Gesellschaft für klinische Studien in der ambulanten Hämatologie und Onkologie
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen
city: Velen
country: Germany
facility: Praxis Dr. G. Dresemann
city: Weilheim
country: Germany
facility: Onkologische Gemeinschaftspraxis Dr. med M. Perker / PF Dr. med M. Sandherr
city: Budapest
country: Hungary
facility: Semmelweis Egyetem Kútvölgyi Klinikai Tömb
city: Budapest
country: Hungary
facility: Fővárosi Önkormányzat Uzsoki utcai Kórház
city: Győr
country: Hungary
facility: Petz Aladár Megyei Oktató Kórház [Onkoradiológiai Oszt
city: Kecskemet
country: Hungary
facility: Bács-Kiskun Megyei Önkormányzat Kórháza, Szegedi
city: Miskolc
country: Hungary
facility: Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház
city: Nyíregyháza
country: Hungary
facility: Josa Andras Oktato Korhaz [Onkologiai Osztaly]
city: Pécs
country: Hungary
facility: Pécsi Tudományegyetem Klinikai Köpont
city: Szolnok
country: Hungary
facility: Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz
city: Ahmedabad
country: India
facility: HCG - Multy Speciality Hospital
city: Ahmedabad
country: India
facility: Hemato-Oncology Clinic Ahmedabad Pvt Ltd
city: Amravati
country: India
facility: Sujan Surgical Cancer Hospital and Amracvati Cancer Foundation
city: Bangalore
country: India
facility: Sri Venkateshwara Hospital [Medical Oncology]
city: Chennai
country: India
facility: Apollo Speciality Hospital
city: Chennai
country: India
facility: Dr. Kamahshi Memorial Hospital [Oncology]
city: Hyderabad
country: India
facility: BIBI General Hospital & Cancer Centre [Oncology]
city: Hyderabad
country: India
facility: Yashoda B-Block Hospital
city: Kolkata
country: India
facility: B.P.Poddar Hospital and Medical Research Ltd
city: Kolkata
country: India
facility: Apollo Gleneagles Hospitals Kolkata
city: Nashik
country: India
facility: Shatabdhi Superspeciality Hospital
city: Pune
country: India
facility: Grant Medical Foundation - Ruby Hall Clinic
city: Vijayawada
country: India
facility: City Cancer Centre [Surgical and Medical Oncology]
city: Brescia
country: Italy
facility: Fondazione Poliambulanza Istituto Ospedaliero
city: Lecce
country: Italy
facility: Ospedale Vito Fazzi, ASL Lecce
city: Lecco
country: Italy
facility: Presidio Ospedaliero "Alessandro Manzoni", AO Provincia di Lecco
city: Negrar
country: Italy
facility: Ospedale Sacro Cuore e Don Calabria - Negrar
city: Potenza
country: Italy
facility: Ospedale S.Carlo di Potenza [U.O. di Oncologia Medica]
city: Chihuahua
country: Mexico
facility: Centro Oncologico De Chihuahua
city: Mexico
country: Mexico
facility: Hospital de Jesus
city: Mexico
country: Mexico
facility: Centro Medico Quirurgico
city: Monterrey
country: Mexico
facility: OCA Hospital/Monterrey International Research Center
city: Monterrey
country: Mexico
facility: Centro Regiomontano de Investigación Clínica
city: Bialystok
country: Poland
facility: Bialostockie Centrum Onkologii im. M.Sklodowskiej-Curie
city: Elblag
country: Poland
facility: Wojewodzki Szpital Zespolony w Elblagu, Oddzial Onkologiczny
city: Koscierzyna
country: Poland
facility: Niepubliczny Specjalist. Onkol. Zaklad Opieki Zdrowotnej
city: Lodz
country: Poland
facility: Wojewodzki Szpital Specjalistyczny im. M.Kopernika
city: Lomza
country: Poland
facility: Szpital Wojewodzki w Lomzy im. Kardynala S. Wyszynskiego
city: Olsztyn
country: Poland
facility: Olsztynski Osrodek Onkologiczny "KOPERNIK"
city: Raciborz
country: Poland
facility: Szpital Rejonowy im. dr J. Rostka w Raciborzu
city: Slupsk
country: Poland
facility: Wojewodzki Szpital Specjalistyczny im. J. Korczaka
city: Warszawa
country: Poland
facility: Centrum Onkologii - Instytut im. Marii Sklodowskiej - Curie
city: Warszawa
country: Poland
facility: NZOZ Magodent - Centrum Medczyne Ostrobramska
city: Baia-Mare
country: Romania
facility: Spitalul Judetean de Urgenta "Dr. Constantin Opris" Baia-Mare [Oncologie Medicala]
city: Bucuresti
country: Romania
facility: Spitalul Universitar de Urgenta Elias [Oncologie Medicala]
city: Bucuresti
country: Romania
facility: Spitalul Clinic CF nr.2 Bucuresti [Oncologie Medicala]
city: Bucuresti
country: Romania
facility: Spitalul Universitar de Urgenta Bucuresti
city: Bucuresti
country: Romania
facility: Institutul Oncologic "Prof. Dr. Alex. Trestioreanu" [Sectia Clinica Radioterapie II]
city: Craiova
country: Romania
facility: Oncolab - Oncology Center Craiova
city: Iasi
country: Romania
facility: Institutul Regional de Oncologia
city: Onesti
country: Romania
facility: Spitalul Municipal Onesti [Sectia Oncologie Medicala]
city: Tg Mures
country: Romania
facility: Spitalul Clinic Judetean Mures
city: Timisoara
country: Romania
facility: Oncomed SRL
city: Arkhangelsk
country: Russian Federation
facility: GUZ Arkhangelsk Regional Clinical Oncological Dispensary
city: Ivanovo
country: Russian Federation
facility: Ivanovo Regional Oncological Dispensary [Chemotherapy]
city: Kazan
country: Russian Federation
facility: GAUZ Republic Clinical Oncology Dispensary of Ministry of Health of Republic Tatarstan
city: Krasnoyarsk
country: Russian Federation
facility: GOU VPO Krasnoyarsk State Medical University n.a. prof. V.F.
city: Lipetsk
country: Russian Federation
facility: GUZ Lipetsk Regional Oncology Dispensary [General Oncology]
city: Magnitogorsk
country: Russian Federation
facility: GUZ Regional Oncology Dispensary #2
city: Moscow
country: Russian Federation
facility: Russian Cancer Research Center
city: Moscow
country: Russian Federation
facility: SBHI of Moscow City Oncology Clinical Hospital #62
city: Novosibirsk
country: Russian Federation
facility: MBUZ City Clinical Hospital #1
city: Obninsk
country: Russian Federation
facility: FGBU Medical Radiology Scientific Center
city: Perm
country: Russian Federation
facility: GUZ Perm Regional Oncology Dispensary
city: Pyatigorsk
country: Russian Federation
facility: GUZ Pyatigorsk Oncology Dispensary [Outpatient Department]
city: Ryazan
country: Russian Federation
facility: GOU VPO - Ryazan State Med. Univer. n.a. I.I.Pavlov based Ryazan Regio
city: Saint Petersburg
country: Russian Federation
facility: City Oncology Dispensary
city: Saint Petersburg
country: Russian Federation
facility: GOU VPO Saint-Petersburg State Medical University n.a. acad.
city: Saint Petersburg
country: Russian Federation
facility: St. Petersburg Clinical Oncology Dispesary - 3rd Gynecology D
city: Saint-Petersburg
country: Russian Federation
facility: GUZ "Leningrad Regional Oncology Dispensary"
city: Samara
country: Russian Federation
facility: GUZ Samara Regional Clinical Oncology Dispensary
city: St. Petersburg
country: Russian Federation
facility: FGU Research Institute of Oncology n.a. N.N.Petrov of Rosmed
city: Stavropol
country: Russian Federation
facility: Stavropol Regional Clinical Oncology Dispensary
city: Ufa
country: Russian Federation
facility: GBUZ - Clinical Oncology Dispensary of MoH of Republic Bahkortostan
city: Ufa
country: Russian Federation
facility: GUZ Republican Clinical Oncological Dispensary of public
city: Cherkasy
country: Ukraine
facility: Komunalnyi "Cherkaskyi oblasnyi onkolohichnyi dyspanser" Cherkaskoi oblasnoi rady, oblasnyi onkokhimioterapevtychnyi tsentr, m. Cherkasy
city: Chernigiv
country: Ukraine
facility: Komunalnyi likuvalno-profilaktychnyi zaklad "Chernigivskyi
city: Chmelnytskyi
country: Ukraine
facility: Chmelnytskyi Regional Clinical Oncology Centre [Oncology]
city: Dnipropetrovks
country: Ukraine
facility: Komunalnyizaklad Miska bahatoprofilna klinichna likarnia #4
city: Donetsk
country: Ukraine
facility: Donetskyi oblasnyi protypukhlynnyi tsentr
city: Kharkiv
country: Ukraine
facility: Kharkivskyi oblasnyi onkologichnyi klinichnyi tsentr
city: Kyiv
country: Ukraine
facility: Kyirskyi Miskyi klinichnyi onkolohichnyi tsentr
city: Kyiv
country: Ukraine
facility: KZ KOR Kyivskyi oblasnyi onkologichnyi dyspanser
city: Lviv
country: Ukraine
facility: Lvivskyi derzhavnyi onkologichnyi regionalnyi likuvalno diahnostychyi tsentr
city: Odessa
country: Ukraine
facility: Odeska oblasna klinichna likarnia
city: Poltava
country: Ukraine
facility: Poltavskyi oblasnyi klinichnyi onkolohichnyi dyspanser Pol
city: Uzhgorod
country: Ukraine
facility: Zakarpatskyi oblasnyi klinichnyi onkodyspanser
Study officials:
References:
citation: 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.
citation: 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.