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

This study has been completed.
Sponsor:
Collaborator:
Parexel
Information provided by (Responsible Party):
Helsinn Healthcare SA
ClinicalTrials.gov Identifier:
NCT01339260
First received: April 19, 2011
Last updated: September 23, 2013
Last verified: September 2013
  Purpose

NETU-08-18 is a 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.


Condition Intervention Phase
Chemotherapy-Induced Nausea and Vomiting
Drug: Netupitant and Palonosetron
Drug: Palonosetron
Drug: Dexamethasone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Helsinn Healthcare SA:

Primary Outcome Measures:
  • Proportion of patients with complete response (CR) defined as no emesis, no rescue medication, at cycle 1 [ Time Frame: 25-120 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of patients with complete response (CR) defined as no emesis, no rescue medication at cycle 1 [ Time Frame: 0-24 hours ] [ Designated as safety issue: No ]
  • Proportion of patients with complete response (CR) defined as no emesis, no rescue medication, at cycle 1 [ Time Frame: 0-120 hours ] [ Designated as safety issue: No ]

Enrollment: 1455
Study Start Date: April 2011
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Netupitant and Palonosetron plus dexamethasone
Oral netupitant/palonosetron (300 mg/0.50 mg) hard capsule with oral dexamethasone, both given on Day 1, prior to each scheduled chemotherapy cycle
Drug: Netupitant and Palonosetron Drug: Dexamethasone
Active Comparator: Palonosetron plus dexamethasone
Oral palonosetron 0.50 mg (Aloxi) with oral dexamethasone both given on Day 1, prior to each scheduled chemotherapy cycle
Drug: Palonosetron Drug: Dexamethasone

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  • 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 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 an 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 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) 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01339260

  Hide Study Locations
Locations
United States, Alabama
Anniston Oncology/Regional Medical Center
Anniston, Alabama, United States, 36207
Northwest Alabama Cancer Center
Muscle Shoals, Alabama, United States, 35661
United States, Arkansas
Genesis Cancer Centre
Hot Springs, Arkansas, United States, 71913
United States, California
Compassionate Cancer Care Medical Group Inc
Corona, California, United States, 92879
Compassionate Cancer Centre Medical Group
Fountain Valley, California, United States, 92708
American Institute of Research
Los Angeles, California, United States, 90017
Facey Medical Group
Mission Hills, California, United States, 91345
Compassionate Cancer Care Medical Group
Riverside, California, United States, 92501
American Institute of Research
Whittier, California, United States, 90603
United States, Colorado
Denver Health and Hospital Authority
Denver, Colorado, United States, 80204
United States, Florida
Palm Beach Institute of Hematology and Oncology
Boynton Beach, Florida, United States, 33435
Baptist Cancer Institute
Jacksonville, Florida, United States, 32207
United States, Indiana
Deaconess Clinic Downtown
Evansville, Indiana, United States, 47713
Floyd Memorial Cancer Center of Indiana
New Albany, Indiana, United States, 47150
United States, Kentucky
Kentucky Cancer Clinic
Hazard, Kentucky, United States, 41701
United States, Maryland
The John R Marsh Cancer Center
Hagerstown, Maryland, United States, 21742
United States, Massachusetts
Fallon Clinic at Worcester Medical Center
Worcester, Massachusetts, United States, 01608
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Piedmont Hematology Oncology Associates PA
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Tri-County Hematology and Oncolgy Associates Inc.
Massillon, Ohio, United States, 44646
Signal Point Clinical Research Center LLC
Middletown, Ohio, United States, 45042
United States, South Carolina
Charleston Hematology Oncology
Charleston, South Carolina, United States, 29414
Charleston Cancer Center
Charleston, South Carolina, United States, 29406
United States, Tennessee
Wellmont Medical Associates-Oncology and Hematology
Bristol, Tennessee, United States, 37620
United States, Texas
Cancer Specialists of South Texas, P.A.
Corpus Christi, Texas, United States, 78412
The University of Texas Health Center
Tyler, Texas, United States, 75708
United States, Utah
Northern Utah Associates Hematology / Oncology
Ogden, Utah, United States, 84403
United States, Washington
Northwest Medical Specialties
Tacoma, Washington, United States, 98405
Argentina
Instituto Oncológico de Córdoba - Sanatorio Aconcagua
Cordoba, Argentina, X5006HBF
Clínica Universitaria Reina Fabiola (Universidad Católica de Córdoba)
Córdoba, Argentina, X5004FHP
Hospital Italiano de Cordoba
Córdoba, Argentina, 5000
Centro Oncológico Integral (COI)
Mar del Plata, Argentina, 7600
Centro Oncologico de Integracion Regional (COIR)
Mendoza, Argentina, M5500AYB
Instituto Médico CER [Oncology]
Quilmes, Argentina, B1878DVB
Sanatorio Parque
Rosario, Argentina, S2000DVS
Centro Medico San Roque
San Miguel de Tucuman, Argentina, T4000AIK
ISIS Clinica Especializada
Santa Fe, Argentina, 3000
Belarus
Bobruisk Interregional Oncological Dispensary
Bobruisk, Belarus, 213825
Brest Regional Oncological Dispensary
Brest, Belarus, 224027
Gomel Regional Clinical Oncological Dispensary
Brest, Belarus, 246012
State institution N.N. Alexandrov Republican Scientific and Practical Center of Oncology and Medical Radiology
Minsk, Belarus, 223040
Minsk city Clinical Oncological Dispensary [Oncology]
Minsk, Belarus, 220013
Mogilev Regional Oncological Dispensary [Oncology]
Mogilev, Belarus, 212018
Brazil
OXION-Medicina Oncológica
Belo Horizonte, Brazil, 30150270
Centro de Pesquisas Clínicas em Oncologia
Cachoeiro de Itapemirim, Brazil, 29308-014
IPCEM - Centro de Ciências da Saúde - Universidade de Caxias
Caxias do Sul, Brazil, 95070-560
Hospital Araújo Jorge
Goiânia, Brazil, 74605-070
Clinica de Neoplasias do Litoral
ItajaÃ, Brazil, 88301-220
Clinica De Oncologia De Porto Alegre S S Ltda
Porto Alegre, Brazil, 90430-090
Hospital Moinhos de Vento
Porto Alegre, Brazil, RS90560-030
Instituto Ribeirãopretano de Combate ao Cancer
Ribeirão Preto, Brazil, 14015-130
Oncotrat Oncologia Medica Ltda [Oncology]
Rio de Janeiro, Brazil, 22451010
Nucleo de Oncologia da Bahia
Salvador Bahia, Brazil, 40170-110
Casa de Saude Santa Marcelina
São Paulo, Brazil, 08270-070
Hospital Santa Cruz
São Paulo, Brazil, 04121-000
Bulgaria
SHATO "Sveti Mina"
Blagoevgrad, Bulgaria, 2700
MHAT Dr. Tota Venkova [Oncology]
Gabrovo, Bulgaria, 5300
Specialized Hospital for Active Treatment of Oncology
Haskovo, Bulgaria, 6300
UMHAT ""Dr. Georgi Stranski"" Dept. Medical Oncology
Pleven, Bulgaria, 5800
UMHAT "Sveti Georgi" [Clinic of Oncology and Hematology]
Plovdiv, Bulgaria, 4002
District Dispensery with Stationary - Sofia District
Sofia, Bulgaria, 1233
Specialized Hospital for Active Treatment of Onclogy Diseases - Sofia City
Sofia, Bulgaria, 1784
UMHAT "Tsaritsa Yoanna - ISUL" Ltd.Medical Oncology Clinic
Sofia, Bulgaria, 1527
Specialized Hospital for Active Treatment in Oncology
Sofia, Bulgaria, 1756
Complex Oncology Centre
Stara Zagora, Bulgaria, 6003
COC - Veliko Tarnovo Dept. Medical Oncology
Veliko Tarnovo, Bulgaria, 5000
Comprehensive Cancer Center - Vratsa Dept. of Palliative Care
Vratsa, Bulgaria, 3000
Croatia
Županijska bolnica Cakovec
Cakovec, Croatia, 40000
Klinicki bolnicki centar Osijek [Oncology]
Osijek, Croatia, 31000
Opca bolnica Pula [Odjel za onklologiju]
Pula, Croatia, 52000
KBC Rijeka [Gastroenterology]
Rijeka, Croatia, 51000
Opca bolnica Varazdin [Odjel za hem.onko i klin.imun.]
Varazdin, Croatia, 42 000
Opca Bolnica Zadal Ulica
Zadar, Croatia, 23000
Klinika za tumore [Odjel za kemoter. i internisticku onkolog
Zagreb, Croatia, 10000
Klinički bolnički centar Zagreb [Oncology]
Zagreb, Croatia, 10 000
Klinicka bolnica [Sestre milosrdnice]
Zagreb, Croatia, 10000
Germany
Klinik und Poliklinik für Onkologie und Hämatologie Universitatsmedizin Charite Mitte
Berlin, Germany, 10117
Gynäkologische Arztpraxis
Berlin, Germany, 10317
OncoResearch Lerchenfeld UG
Hamburg, Germany, 22081
Schwerpktprxs gynäkolog Onkologie Prof. Dr. Diel, Dr. Gebert
Mannheim, Germany, 68161
Staedtisches Krankenhaus Muenchen Neuperlach
München, Germany, 81737
Tumorzentrum Munchen Sued - Städtisches Klinikum [Hämato-, Onkologie + Palliativmed]
München, Germany, 81545
Rotkreuzklinikum [München]
München, Germany, 80637
OncoPRO GbR Dr. R. Dengler, Dr. A. Kröber Gesellschaft für klinische Studien in der ambulanten Hämatologie und Onkologie
Regensburg, Germany, 93053
Universitätsklinikum Tübingen
Tübingen, Germany, 72076
Praxis Dr. G. Dresemann
Velen, Germany, 46342
Onkologische Gemeinschaftspraxis Dr. med M. Perker / PF Dr. med M. Sandherr
Weilheim, Germany, 82362
Hungary
Semmelweis Egyetem Kútvölgyi Klinikai Tömb
Budapest, Hungary, 1125
Fővárosi Önkormányzat Uzsoki utcai Kórház
Budapest, Hungary, 1145
Petz Aladár Megyei Oktató Kórház [Onkoradiológiai Oszt
Győr, Hungary, 9024
Bács-Kiskun Megyei Önkormányzat Kórháza, Szegedi
Kecskemet, Hungary, 6000
Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház
Miskolc, Hungary, 3526
Josa Andras Oktato Korhaz [Onkologiai Osztaly]
Nyíregyháza, Hungary, 4400
Pécsi Tudományegyetem Klinikai Köpont
Pécs, Hungary, 7624
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz
Szolnok, Hungary, 5004
India
Hemato-Oncology Clinic Ahmedabad Pvt Ltd
Ahmedabad, India, 380009
HCG - Multy Speciality Hospital
Ahmedabad, India, 380006
Sujan Surgical Cancer Hospital and Amracvati Cancer Foundation
Amravati, India, 444606
Sri Venkateshwara Hospital [Medical Oncology]
Bangalore, India, 560068
Apollo Speciality Hospital
Chennai, India, 600035
Dr. Kamahshi Memorial Hospital [Oncology]
Chennai, India, 600100
Yashoda B-Block Hospital
Hyderabad, India, 500 082
BIBI General Hospital & Cancer Centre [Oncology]
Hyderabad, India, 500 024
B.P.Poddar Hospital and Medical Research Ltd
Kolkata, India, 700053
Apollo Gleneagles Hospitals Kolkata
Kolkata, India, 700054
Shatabdhi Superspeciality Hospital
Nashik, India, 422005
Grant Medical Foundation - Ruby Hall Clinic
Pune, India, 411001
City Cancer Centre [Surgical and Medical Oncology]
Vijayawada, India, 520002
Italy
Fondazione Poliambulanza Istituto Ospedaliero
Brescia, Italy, 25124
Ospedale Vito Fazzi, ASL Lecce
Lecce, Italy, 73100
Presidio Ospedaliero "Alessandro Manzoni", AO Provincia di Lecco
Lecco, Italy, 23900
Ospedale Sacro Cuore e Don Calabria - Negrar
Negrar, Italy, 37024
Ospedale S.Carlo di Potenza [U.O. di Oncologia Medica]
Potenza, Italy, 85100
Mexico
Centro Oncologico De Chihuahua
Chihuahua, Mexico, 31217
Centro Medico Quirurgico
Mexico, Mexico, 20234
Hospital de Jesus
Mexico, Mexico, 06090
Centro Regiomontano de Investigación Clínica
Monterrey, Mexico, 64710
OCA Hospital/Monterrey International Research Center
Monterrey, Mexico, 64000
Poland
Bialostockie Centrum Onkologii im. M.Sklodowskiej-Curie
Bialystok, Poland, 15-027
Wojewodzki Szpital Zespolony w Elblagu, Oddzial Onkologiczny
Elblag, Poland, 82-200
Niepubliczny Specjalist. Onkol. Zaklad Opieki Zdrowotnej
Koscierzyna, Poland, 83-400
Wojewodzki Szpital Specjalistyczny im. M.Kopernika
Lodz, Poland, 93-513
Szpital Wojewodzki w Lomzy im. Kardynala S. Wyszynskiego
Lomza, Poland, 18-400
Olsztynski Osrodek Onkologiczny "KOPERNIK"
Olsztyn, Poland, 10-513
Szpital Rejonowy im. dr J. Rostka w Raciborzu
Raciborz, Poland, 47-400
Wojewodzki Szpital Specjalistyczny im. J. Korczaka
Slupsk, Poland, 76-200
Centrum Onkologii - Instytut im. Marii Sklodowskiej - Curie
Warszawa, Poland, 02-781
NZOZ Magodent - Centrum Medczyne Ostrobramska
Warszawa, Poland, 04-125
Romania
Spitalul Judetean de Urgenta "Dr. Constantin Opris" Baia-Mare [Oncologie Medicala]
Baia-Mare, Romania, 430031
Institutul Oncologic "Prof. Dr. Alex. Trestioreanu" [Sectia Clinica Radioterapie II]
Bucuresti, Romania, 22328
Spitalul Clinic CF nr.2 Bucuresti [Oncologie Medicala]
Bucuresti, Romania, 011464
Spitalul Universitar de Urgenta Bucuresti
Bucuresti, Romania, 050098
Spitalul Universitar de Urgenta Elias [Oncologie Medicala]
Bucuresti, Romania, 011461
Oncolab - Oncology Center Craiova
Craiova, Romania, 200385
Institutul Regional de Oncologia
Iasi, Romania, 700483
Spitalul Municipal Onesti [Sectia Oncologie Medicala]
Onesti, Romania, 601048
Spitalul Clinic Judetean Mures
Tg Mures, Romania, 0540142
Oncomed SRL
Timisoara, Romania, 300239
Russian Federation
GUZ Arkhangelsk Regional Clinical Oncological Dispensary
Arkhangelsk, Russian Federation, 163045
Ivanovo Regional Oncological Dispensary [Chemotherapy]
Ivanovo, Russian Federation, 153013
GAUZ Republic Clinical Oncology Dispensary of Ministry of Health of Republic Tatarstan
Kazan, Russian Federation, 420029
GOU VPO Krasnoyarsk State Medical University n.a. prof. V.F.
Krasnoyarsk, Russian Federation, 660133
GUZ Lipetsk Regional Oncology Dispensary [General Oncology]
Lipetsk, Russian Federation, 398005
GUZ Regional Oncology Dispensary #2
Magnitogorsk, Russian Federation, 455001
SBHI of Moscow City Oncology Clinical Hospital #62
Moscow, Russian Federation, 143423
Russian Cancer Research Center
Moscow, Russian Federation, 115478
MBUZ City Clinical Hospital #1
Novosibirsk, Russian Federation, 630047
FGBU Medical Radiology Scientific Center
Obninsk, Russian Federation, 249036
GUZ Perm Regional Oncology Dispensary
Perm, Russian Federation, 614066
GUZ Pyatigorsk Oncology Dispensary [Outpatient Department]
Pyatigorsk, Russian Federation, 357502
GOU VPO - Ryazan State Med. Univer. n.a. I.I.Pavlov based Ryazan Regio
Ryazan, Russian Federation, 390026
City Oncology Dispensary
Saint Petersburg, Russian Federation, 197022
St. Petersburg Clinical Oncology Dispesary - 3rd Gynecology D
Saint Petersburg, Russian Federation, 197022
GOU VPO Saint-Petersburg State Medical University n.a. acad.
Saint Petersburg, Russian Federation, 197022
GUZ "Leningrad Regional Oncology Dispensary"
Saint-Petersburg, Russian Federation, 188663
GUZ Samara Regional Clinical Oncology Dispensary
Samara, Russian Federation, 443031
FGU Research Institute of Oncology n.a. N.N.Petrov of Rosmed
St. Petersburg, Russian Federation, 197758
Stavropol Regional Clinical Oncology Dispensary
Stavropol, Russian Federation, 355047
GBUZ - Clinical Oncology Dispensary of MoH of Republic Bahkortostan
Ufa, Russian Federation, 450054
GUZ Republican Clinical Oncological Dispensary of public
Ufa, Russian Federation, 450054
Ukraine
Komunalnyi "Cherkaskyi oblasnyi onkolohichnyi dyspanser" Cherkaskoi oblasnoi rady, oblasnyi onkokhimioterapevtychnyi tsentr, m. Cherkasy
Cherkasy, Ukraine, 18009
Komunalnyi likuvalno-profilaktychnyi zaklad "Chernigivskyi
Chernigiv, Ukraine, 14029
Chmelnytskyi Regional Clinical Oncology Centre [Oncology]
Chmelnytskyi, Ukraine, 29009
Komunalnyizaklad Miska bahatoprofilna klinichna likarnia #4
Dnipropetrovks, Ukraine, 49102
Donetskyi oblasnyi protypukhlynnyi tsentr
Donetsk, Ukraine, 83092
Kharkivskyi oblasnyi onkologichnyi klinichnyi tsentr
Kharkiv, Ukraine, 61070
Kyirskyi Miskyi klinichnyi onkolohichnyi tsentr
Kyiv, Ukraine, 03115
KZ KOR Kyivskyi oblasnyi onkologichnyi dyspanser
Kyiv, Ukraine, 04107
Lvivskyi derzhavnyi onkologichnyi regionalnyi likuvalno diahnostychyi tsentr
Lviv, Ukraine, 79031
Odeska oblasna klinichna likarnia
Odessa, Ukraine, 65025
Poltavskyi oblasnyi klinichnyi onkolohichnyi dyspanser Pol
Poltava, Ukraine, 36011
Zakarpatskyi oblasnyi klinichnyi onkodyspanser
Uzhgorod, Ukraine, 88014
Sponsors and Collaborators
Helsinn Healthcare SA
Parexel
  More Information

No publications provided

Responsible Party: Helsinn Healthcare SA
ClinicalTrials.gov Identifier: NCT01339260     History of Changes
Other Study ID Numbers: NETU-08-18
Study First Received: April 19, 2011
Last Updated: September 23, 2013
Health Authority: United States: Food and Drug Administration
Argentina: Ministry of Health
Belarus: Ministry of Health
Brazil: Ministry of Health
Brazil: National Committee of Ethics in Research
Hungary: National Institute of Pharmacy
Germany: Federal Institute for Drugs and Medical Devices
Romania: National Medicines Agency
Romania: Ethics Committee
Bulgaria: Bulgarian Drug Agency
Bulgaria: Ethics committee
Croatia: Agency for Medicinal Product and Medical Devices
Croatia: Ethics Committee
Poland: National Institute of Medicines
Poland: Ethics Committee
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Ukraine: Ethics Committee
Ukraine: Ministry of Health
Russia: Pharmacological Committee, Ministry of Health
Mexico: Ministry of Health
Mexico: Ethics Committee
India: Central Drugs Standard Control Organization
India: Institutional Review Board

Additional relevant MeSH terms:
Nausea
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Palonosetron
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on September 18, 2014