Spots Global Cancer Trial Database for An Efficacy and Safety Study of Oral Netupitant and Palonosetron for the Prevention of Nausea and Vomiting
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Trial Identification
Brief Title: 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 ID: NCT01339260
Conditions
Study Description
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).
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Anniston Oncology/Regional Medical Center, Anniston, Alabama, United States
Northwest Alabama Cancer Center, Muscle Shoals, Alabama, United States
Genesis Cancer Centre, Hot Springs, Arkansas, United States
Compassionate Cancer Care Medical Group Inc, Corona, California, United States
Compassionate Cancer Centre Medical Group, Fountain Valley, California, United States
American Institute of Research, Los Angeles, California, United States
Facey Medical Group, Mission Hills, California, United States
Compassionate Cancer Care Medical Group, Riverside, California, United States
American Institute of Research, Whittier, California, United States
Denver Health and Hospital Authority, Denver, Colorado, United States
Palm Beach Institute of Hematology and Oncology, Boynton Beach, Florida, United States
Baptist Cancer Institute, Jacksonville, Florida, United States
Deaconess Clinic Downtown, Evansville, Indiana, United States
Floyd Memorial Cancer Center of Indiana, New Albany, Indiana, United States
Kentucky Cancer Clinic, Hazard, Kentucky, United States
The John R Marsh Cancer Center, Hagerstown, Maryland, United States
Fallon Clinic at Worcester Medical Center, Worcester, Massachusetts, United States
Duke University Medical Center, Durham, North Carolina, United States
Piedmont Hematology Oncology Associates PA, Winston-Salem, North Carolina, United States
Tri-County Hematology and Oncolgy Associates Inc., Massillon, Ohio, United States
Signal Point Clinical Research Center LLC, Middletown, Ohio, United States
Charleston Cancer Center, Charleston, South Carolina, United States
Charleston Hematology Oncology, Charleston, South Carolina, United States
Wellmont Medical Associates-Oncology and Hematology, Bristol, Tennessee, United States
Cancer Specialists of South Texas, P.A., Corpus Christi, Texas, United States
The University of Texas Health Center, Tyler, Texas, United States
Northern Utah Associates Hematology / Oncology, Ogden, Utah, United States
Northwest Medical Specialties, Tacoma, Washington, United States
Instituto Oncológico de Córdoba - Sanatorio Aconcagua, Cordoba, , Argentina
Hospital Italiano de Cordoba, Córdoba, , Argentina
Clínica Universitaria Reina Fabiola (Universidad Católica de Córdoba), Córdoba, , Argentina
Centro Oncológico Integral (COI), Mar del Plata, , Argentina
Centro Oncologico de Integracion Regional (COIR), Mendoza, , Argentina
Instituto Médico CER [Oncology], Quilmes, , Argentina
Sanatorio Parque, Rosario, , Argentina
Centro Medico San Roque, San Miguel de Tucuman, , Argentina
ISIS Clinica Especializada, Santa Fe, , Argentina
Bobruisk Interregional Oncological Dispensary, Bobruisk, , Belarus
Brest Regional Oncological Dispensary, Brest, , Belarus
Gomel Regional Clinical Oncological Dispensary, Brest, , Belarus
Minsk city Clinical Oncological Dispensary [Oncology], Minsk, , Belarus
State institution N.N. Alexandrov Republican Scientific and Practical Center of Oncology and Medical Radiology, Minsk, , Belarus
Mogilev Regional Oncological Dispensary [Oncology], Mogilev, , Belarus
OXION-Medicina Oncológica, Belo Horizonte, , Brazil
Centro de Pesquisas Clínicas em Oncologia, Cachoeiro de Itapemirim, , Brazil
IPCEM - Centro de Ciências da Saúde - Universidade de Caxias, Caxias do Sul, , Brazil
Hospital Araújo Jorge, Goiânia, , Brazil
Clinica de Neoplasias do Litoral, ItajaÃ, , Brazil
Clinica De Oncologia De Porto Alegre S S Ltda, Porto Alegre, , Brazil
Hospital Moinhos de Vento, Porto Alegre, , Brazil
Instituto Ribeirãopretano de Combate ao Cancer, Ribeirão Preto, , Brazil
Oncotrat Oncologia Medica Ltda [Oncology], Rio de Janeiro, , Brazil
Nucleo de Oncologia da Bahia, Salvador Bahia, , Brazil
Hospital Santa Cruz, São Paulo, , Brazil
Casa de Saude Santa Marcelina, São Paulo, , Brazil
SHATO "Sveti Mina", Blagoevgrad, , Bulgaria
MHAT Dr. Tota Venkova [Oncology], Gabrovo, , Bulgaria
Specialized Hospital for Active Treatment of Oncology, Haskovo, , Bulgaria
UMHAT ""Dr. Georgi Stranski"" Dept. Medical Oncology, Pleven, , Bulgaria
UMHAT "Sveti Georgi" [Clinic of Oncology and Hematology], Plovdiv, , Bulgaria
District Dispensery with Stationary - Sofia District, Sofia, , Bulgaria
UMHAT "Tsaritsa Yoanna - ISUL" Ltd.Medical Oncology Clinic, Sofia, , Bulgaria
Specialized Hospital for Active Treatment in Oncology, Sofia, , Bulgaria
Specialized Hospital for Active Treatment of Onclogy Diseases - Sofia City, Sofia, , Bulgaria
Complex Oncology Centre, Stara Zagora, , Bulgaria
COC - Veliko Tarnovo Dept. Medical Oncology, Veliko Tarnovo, , Bulgaria
Comprehensive Cancer Center - Vratsa Dept. of Palliative Care, Vratsa, , Bulgaria
Županijska bolnica Cakovec, Cakovec, , Croatia
Klinicki bolnicki centar Osijek [Oncology], Osijek, , Croatia
Opca bolnica Pula [Odjel za onklologiju], Pula, , Croatia
KBC Rijeka [Gastroenterology], Rijeka, , Croatia
Opca bolnica Varazdin [Odjel za hem.onko i klin.imun.], Varazdin, , Croatia
Opca Bolnica Zadal Ulica, Zadar, , Croatia
Klinički bolnički centar Zagreb [Oncology], Zagreb, , Croatia
Klinicka bolnica [Sestre milosrdnice], Zagreb, , Croatia
Klinika za tumore [Odjel za kemoter. i internisticku onkolog, Zagreb, , Croatia
Klinik und Poliklinik für Onkologie und Hämatologie Universitatsmedizin Charite Mitte, Berlin, , Germany
Gynäkologische Arztpraxis, Berlin, , Germany
OncoResearch Lerchenfeld UG, Hamburg, , Germany
Schwerpktprxs gynäkolog Onkologie Prof. Dr. Diel, Dr. Gebert, Mannheim, , Germany
Rotkreuzklinikum [München], München, , Germany
Tumorzentrum Munchen Sued - Städtisches Klinikum [Hämato-, Onkologie + Palliativmed], München, , Germany
Staedtisches Krankenhaus Muenchen Neuperlach, München, , Germany
OncoPRO GbR Dr. R. Dengler, Dr. A. Kröber Gesellschaft für klinische Studien in der ambulanten Hämatologie und Onkologie, Regensburg, , Germany
Universitätsklinikum Tübingen, Tübingen, , Germany
Praxis Dr. G. Dresemann, Velen, , Germany
Onkologische Gemeinschaftspraxis Dr. med M. Perker / PF Dr. med M. Sandherr, Weilheim, , Germany
Semmelweis Egyetem Kútvölgyi Klinikai Tömb, Budapest, , Hungary
Fővárosi Önkormányzat Uzsoki utcai Kórház, Budapest, , Hungary
Petz Aladár Megyei Oktató Kórház [Onkoradiológiai Oszt, Győr, , Hungary
Bács-Kiskun Megyei Önkormányzat Kórháza, Szegedi, Kecskemet, , Hungary
Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház, Miskolc, , Hungary
Josa Andras Oktato Korhaz [Onkologiai Osztaly], Nyíregyháza, , Hungary
Pécsi Tudományegyetem Klinikai Köpont, Pécs, , Hungary
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz, Szolnok, , Hungary
HCG - Multy Speciality Hospital, Ahmedabad, , India
Hemato-Oncology Clinic Ahmedabad Pvt Ltd, Ahmedabad, , India
Sujan Surgical Cancer Hospital and Amracvati Cancer Foundation, Amravati, , India
Sri Venkateshwara Hospital [Medical Oncology], Bangalore, , India
Apollo Speciality Hospital, Chennai, , India
Dr. Kamahshi Memorial Hospital [Oncology], Chennai, , India
BIBI General Hospital & Cancer Centre [Oncology], Hyderabad, , India
Yashoda B-Block Hospital, Hyderabad, , India
B.P.Poddar Hospital and Medical Research Ltd, Kolkata, , India
Apollo Gleneagles Hospitals Kolkata, Kolkata, , India
Shatabdhi Superspeciality Hospital, Nashik, , India
Grant Medical Foundation - Ruby Hall Clinic, Pune, , India
City Cancer Centre [Surgical and Medical Oncology], Vijayawada, , India
Fondazione Poliambulanza Istituto Ospedaliero, Brescia, , Italy
Ospedale Vito Fazzi, ASL Lecce, Lecce, , Italy
Presidio Ospedaliero "Alessandro Manzoni", AO Provincia di Lecco, Lecco, , Italy
Ospedale Sacro Cuore e Don Calabria - Negrar, Negrar, , Italy
Ospedale S.Carlo di Potenza [U.O. di Oncologia Medica], Potenza, , Italy
Centro Oncologico De Chihuahua, Chihuahua, , Mexico
Hospital de Jesus, Mexico, , Mexico
Centro Medico Quirurgico, Mexico, , Mexico
OCA Hospital/Monterrey International Research Center, Monterrey, , Mexico
Centro Regiomontano de Investigación Clínica, Monterrey, , Mexico
Bialostockie Centrum Onkologii im. M.Sklodowskiej-Curie, Bialystok, , Poland
Wojewodzki Szpital Zespolony w Elblagu, Oddzial Onkologiczny, Elblag, , Poland
Niepubliczny Specjalist. Onkol. Zaklad Opieki Zdrowotnej, Koscierzyna, , Poland
Wojewodzki Szpital Specjalistyczny im. M.Kopernika, Lodz, , Poland
Szpital Wojewodzki w Lomzy im. Kardynala S. Wyszynskiego, Lomza, , Poland
Olsztynski Osrodek Onkologiczny "KOPERNIK", Olsztyn, , Poland
Szpital Rejonowy im. dr J. Rostka w Raciborzu, Raciborz, , Poland
Wojewodzki Szpital Specjalistyczny im. J. Korczaka, Slupsk, , Poland
Centrum Onkologii - Instytut im. Marii Sklodowskiej - Curie, Warszawa, , Poland
NZOZ Magodent - Centrum Medczyne Ostrobramska, Warszawa, , Poland
Spitalul Judetean de Urgenta "Dr. Constantin Opris" Baia-Mare [Oncologie Medicala], Baia-Mare, , Romania
Spitalul Universitar de Urgenta Elias [Oncologie Medicala], Bucuresti, , Romania
Spitalul Clinic CF nr.2 Bucuresti [Oncologie Medicala], Bucuresti, , Romania
Spitalul Universitar de Urgenta Bucuresti, Bucuresti, , Romania
Institutul Oncologic "Prof. Dr. Alex. Trestioreanu" [Sectia Clinica Radioterapie II], Bucuresti, , Romania
Oncolab - Oncology Center Craiova, Craiova, , Romania
Institutul Regional de Oncologia, Iasi, , Romania
Spitalul Municipal Onesti [Sectia Oncologie Medicala], Onesti, , Romania
Spitalul Clinic Judetean Mures, Tg Mures, , Romania
Oncomed SRL, Timisoara, , Romania
GUZ Arkhangelsk Regional Clinical Oncological Dispensary, Arkhangelsk, , Russian Federation
Ivanovo Regional Oncological Dispensary [Chemotherapy], Ivanovo, , Russian Federation
GAUZ Republic Clinical Oncology Dispensary of Ministry of Health of Republic Tatarstan, Kazan, , Russian Federation
GOU VPO Krasnoyarsk State Medical University n.a. prof. V.F., Krasnoyarsk, , Russian Federation
GUZ Lipetsk Regional Oncology Dispensary [General Oncology], Lipetsk, , Russian Federation
GUZ Regional Oncology Dispensary #2, Magnitogorsk, , Russian Federation
Russian Cancer Research Center, Moscow, , Russian Federation
SBHI of Moscow City Oncology Clinical Hospital #62, Moscow, , Russian Federation
MBUZ City Clinical Hospital #1, Novosibirsk, , Russian Federation
FGBU Medical Radiology Scientific Center, Obninsk, , Russian Federation
GUZ Perm Regional Oncology Dispensary, Perm, , Russian Federation
GUZ Pyatigorsk Oncology Dispensary [Outpatient Department], Pyatigorsk, , Russian Federation
GOU VPO - Ryazan State Med. Univer. n.a. I.I.Pavlov based Ryazan Regio, Ryazan, , Russian Federation
City Oncology Dispensary, Saint Petersburg, , Russian Federation
GOU VPO Saint-Petersburg State Medical University n.a. acad., Saint Petersburg, , Russian Federation
St. Petersburg Clinical Oncology Dispesary - 3rd Gynecology D, Saint Petersburg, , Russian Federation
GUZ "Leningrad Regional Oncology Dispensary", Saint-Petersburg, , Russian Federation
GUZ Samara Regional Clinical Oncology Dispensary, Samara, , Russian Federation
FGU Research Institute of Oncology n.a. N.N.Petrov of Rosmed, St. Petersburg, , Russian Federation
Stavropol Regional Clinical Oncology Dispensary, Stavropol, , Russian Federation
GBUZ - Clinical Oncology Dispensary of MoH of Republic Bahkortostan, Ufa, , Russian Federation
GUZ Republican Clinical Oncological Dispensary of public, Ufa, , Russian Federation
Komunalnyi "Cherkaskyi oblasnyi onkolohichnyi dyspanser" Cherkaskoi oblasnoi rady, oblasnyi onkokhimioterapevtychnyi tsentr, m. Cherkasy, Cherkasy, , Ukraine
Komunalnyi likuvalno-profilaktychnyi zaklad "Chernigivskyi, Chernigiv, , Ukraine
Chmelnytskyi Regional Clinical Oncology Centre [Oncology], Chmelnytskyi, , Ukraine
Komunalnyizaklad Miska bahatoprofilna klinichna likarnia #4, Dnipropetrovks, , Ukraine
Donetskyi oblasnyi protypukhlynnyi tsentr, Donetsk, , Ukraine
Kharkivskyi oblasnyi onkologichnyi klinichnyi tsentr, Kharkiv, , Ukraine
Kyirskyi Miskyi klinichnyi onkolohichnyi tsentr, Kyiv, , Ukraine
KZ KOR Kyivskyi oblasnyi onkologichnyi dyspanser, Kyiv, , Ukraine
Lvivskyi derzhavnyi onkologichnyi regionalnyi likuvalno diahnostychyi tsentr, Lviv, , Ukraine
Odeska oblasna klinichna likarnia, Odessa, , Ukraine
Poltavskyi oblasnyi klinichnyi onkolohichnyi dyspanser Pol, Poltava, , Ukraine
Zakarpatskyi oblasnyi klinichnyi onkodyspanser, Uzhgorod, , Ukraine
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