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

Primary Purpose

Chemotherapy-Induced Nausea and Vomiting

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Netupitant and Palonosetron
Palonosetron
Dexamethasone
Sponsored by
Helsinn Healthcare SA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chemotherapy-Induced Nausea and Vomiting

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Anniston Oncology/Regional Medical Center
  • Northwest Alabama Cancer Center
  • Genesis Cancer Centre
  • Compassionate Cancer Care Medical Group Inc
  • Compassionate Cancer Centre Medical Group
  • American Institute of Research
  • Facey Medical Group
  • Compassionate Cancer Care Medical Group
  • American Institute of Research
  • Denver Health and Hospital Authority
  • Palm Beach Institute of Hematology and Oncology
  • Baptist Cancer Institute
  • Deaconess Clinic Downtown
  • Floyd Memorial Cancer Center of Indiana
  • Kentucky Cancer Clinic
  • The John R Marsh Cancer Center
  • Fallon Clinic at Worcester Medical Center
  • Duke University Medical Center
  • Piedmont Hematology Oncology Associates PA
  • Tri-County Hematology and Oncolgy Associates Inc.
  • Signal Point Clinical Research Center LLC
  • Charleston Cancer Center
  • Charleston Hematology Oncology
  • Wellmont Medical Associates-Oncology and Hematology
  • Cancer Specialists of South Texas, P.A.
  • The University of Texas Health Center
  • Northern Utah Associates Hematology / Oncology
  • Northwest Medical Specialties
  • Instituto Oncológico de Córdoba - Sanatorio Aconcagua
  • Hospital Italiano de Cordoba
  • Clínica Universitaria Reina Fabiola (Universidad Católica de Córdoba)
  • Centro Oncológico Integral (COI)
  • Centro Oncologico de Integracion Regional (COIR)
  • Instituto Médico CER [Oncology]
  • Sanatorio Parque
  • Centro Medico San Roque
  • ISIS Clinica Especializada
  • Bobruisk Interregional Oncological Dispensary
  • Brest Regional Oncological Dispensary
  • Gomel Regional Clinical Oncological Dispensary
  • Minsk city Clinical Oncological Dispensary [Oncology]
  • State institution N.N. Alexandrov Republican Scientific and Practical Center of Oncology and Medical Radiology
  • Mogilev Regional Oncological Dispensary [Oncology]
  • OXION-Medicina Oncológica
  • Centro de Pesquisas Clínicas em Oncologia
  • IPCEM - Centro de Ciências da Saúde - Universidade de Caxias
  • Hospital Araújo Jorge
  • Clinica de Neoplasias do Litoral
  • Clinica De Oncologia De Porto Alegre S S Ltda
  • Hospital Moinhos de Vento
  • Instituto Ribeirãopretano de Combate ao Cancer
  • Oncotrat Oncologia Medica Ltda [Oncology]
  • Nucleo de Oncologia da Bahia
  • Hospital Santa Cruz
  • Casa de Saude Santa Marcelina
  • SHATO "Sveti Mina"
  • MHAT Dr. Tota Venkova [Oncology]
  • Specialized Hospital for Active Treatment of Oncology
  • UMHAT ""Dr. Georgi Stranski"" Dept. Medical Oncology
  • UMHAT "Sveti Georgi" [Clinic of Oncology and Hematology]
  • District Dispensery with Stationary - Sofia District
  • UMHAT "Tsaritsa Yoanna - ISUL" Ltd.Medical Oncology Clinic
  • Specialized Hospital for Active Treatment in Oncology
  • Specialized Hospital for Active Treatment of Onclogy Diseases - Sofia City
  • Complex Oncology Centre
  • COC - Veliko Tarnovo Dept. Medical Oncology
  • Comprehensive Cancer Center - Vratsa Dept. of Palliative Care
  • Županijska bolnica Cakovec
  • Klinicki bolnicki centar Osijek [Oncology]
  • Opca bolnica Pula [Odjel za onklologiju]
  • KBC Rijeka [Gastroenterology]
  • Opca bolnica Varazdin [Odjel za hem.onko i klin.imun.]
  • Opca Bolnica Zadal Ulica
  • Klinički bolnički centar Zagreb [Oncology]
  • Klinicka bolnica [Sestre milosrdnice]
  • Klinika za tumore [Odjel za kemoter. i internisticku onkolog
  • Klinik und Poliklinik für Onkologie und Hämatologie Universitatsmedizin Charite Mitte
  • Gynäkologische Arztpraxis
  • OncoResearch Lerchenfeld UG
  • Schwerpktprxs gynäkolog Onkologie Prof. Dr. Diel, Dr. Gebert
  • Rotkreuzklinikum [München]
  • Tumorzentrum Munchen Sued - Städtisches Klinikum [Hämato-, Onkologie + Palliativmed]
  • Staedtisches Krankenhaus Muenchen Neuperlach
  • OncoPRO GbR Dr. R. Dengler, Dr. A. Kröber Gesellschaft für klinische Studien in der ambulanten Hämatologie und Onkologie
  • Universitätsklinikum Tübingen
  • Praxis Dr. G. Dresemann
  • Onkologische Gemeinschaftspraxis Dr. med M. Perker / PF Dr. med M. Sandherr
  • Semmelweis Egyetem Kútvölgyi Klinikai Tömb
  • Fővárosi Önkormányzat Uzsoki utcai Kórház
  • Petz Aladár Megyei Oktató Kórház [Onkoradiológiai Oszt
  • Bács-Kiskun Megyei Önkormányzat Kórháza, Szegedi
  • Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház
  • Josa Andras Oktato Korhaz [Onkologiai Osztaly]
  • Pécsi Tudományegyetem Klinikai Köpont
  • Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz
  • HCG - Multy Speciality Hospital
  • Hemato-Oncology Clinic Ahmedabad Pvt Ltd
  • Sujan Surgical Cancer Hospital and Amracvati Cancer Foundation
  • Sri Venkateshwara Hospital [Medical Oncology]
  • Apollo Speciality Hospital
  • Dr. Kamahshi Memorial Hospital [Oncology]
  • BIBI General Hospital & Cancer Centre [Oncology]
  • Yashoda B-Block Hospital
  • B.P.Poddar Hospital and Medical Research Ltd
  • Apollo Gleneagles Hospitals Kolkata
  • Shatabdhi Superspeciality Hospital
  • Grant Medical Foundation - Ruby Hall Clinic
  • City Cancer Centre [Surgical and Medical Oncology]
  • Fondazione Poliambulanza Istituto Ospedaliero
  • Ospedale Vito Fazzi, ASL Lecce
  • Presidio Ospedaliero "Alessandro Manzoni", AO Provincia di Lecco
  • Ospedale Sacro Cuore e Don Calabria - Negrar
  • Ospedale S.Carlo di Potenza [U.O. di Oncologia Medica]
  • Centro Oncologico De Chihuahua
  • Hospital de Jesus
  • Centro Medico Quirurgico
  • OCA Hospital/Monterrey International Research Center
  • Centro Regiomontano de Investigación Clínica
  • Bialostockie Centrum Onkologii im. M.Sklodowskiej-Curie
  • Wojewodzki Szpital Zespolony w Elblagu, Oddzial Onkologiczny
  • Niepubliczny Specjalist. Onkol. Zaklad Opieki Zdrowotnej
  • Wojewodzki Szpital Specjalistyczny im. M.Kopernika
  • Szpital Wojewodzki w Lomzy im. Kardynala S. Wyszynskiego
  • Olsztynski Osrodek Onkologiczny "KOPERNIK"
  • Szpital Rejonowy im. dr J. Rostka w Raciborzu
  • Wojewodzki Szpital Specjalistyczny im. J. Korczaka
  • Centrum Onkologii - Instytut im. Marii Sklodowskiej - Curie
  • NZOZ Magodent - Centrum Medczyne Ostrobramska
  • Spitalul Judetean de Urgenta "Dr. Constantin Opris" Baia-Mare [Oncologie Medicala]
  • Spitalul Universitar de Urgenta Elias [Oncologie Medicala]
  • Spitalul Clinic CF nr.2 Bucuresti [Oncologie Medicala]
  • Spitalul Universitar de Urgenta Bucuresti
  • Institutul Oncologic "Prof. Dr. Alex. Trestioreanu" [Sectia Clinica Radioterapie II]
  • Oncolab - Oncology Center Craiova
  • Institutul Regional de Oncologia
  • Spitalul Municipal Onesti [Sectia Oncologie Medicala]
  • Spitalul Clinic Judetean Mures
  • Oncomed SRL
  • GUZ Arkhangelsk Regional Clinical Oncological Dispensary
  • Ivanovo Regional Oncological Dispensary [Chemotherapy]
  • GAUZ Republic Clinical Oncology Dispensary of Ministry of Health of Republic Tatarstan
  • GOU VPO Krasnoyarsk State Medical University n.a. prof. V.F.
  • GUZ Lipetsk Regional Oncology Dispensary [General Oncology]
  • GUZ Regional Oncology Dispensary #2
  • Russian Cancer Research Center
  • SBHI of Moscow City Oncology Clinical Hospital #62
  • MBUZ City Clinical Hospital #1
  • FGBU Medical Radiology Scientific Center
  • GUZ Perm Regional Oncology Dispensary
  • GUZ Pyatigorsk Oncology Dispensary [Outpatient Department]
  • GOU VPO - Ryazan State Med. Univer. n.a. I.I.Pavlov based Ryazan Regio
  • City Oncology Dispensary
  • GOU VPO Saint-Petersburg State Medical University n.a. acad.
  • St. Petersburg Clinical Oncology Dispesary - 3rd Gynecology D
  • GUZ "Leningrad Regional Oncology Dispensary"
  • GUZ Samara Regional Clinical Oncology Dispensary
  • FGU Research Institute of Oncology n.a. N.N.Petrov of Rosmed
  • Stavropol Regional Clinical Oncology Dispensary
  • GBUZ - Clinical Oncology Dispensary of MoH of Republic Bahkortostan
  • GUZ Republican Clinical Oncological Dispensary of public
  • Komunalnyi "Cherkaskyi oblasnyi onkolohichnyi dyspanser" Cherkaskoi oblasnoi rady, oblasnyi onkokhimioterapevtychnyi tsentr, m. Cherkasy
  • Komunalnyi likuvalno-profilaktychnyi zaklad "Chernigivskyi
  • Chmelnytskyi Regional Clinical Oncology Centre [Oncology]
  • Komunalnyizaklad Miska bahatoprofilna klinichna likarnia #4
  • Donetskyi oblasnyi protypukhlynnyi tsentr
  • Kharkivskyi oblasnyi onkologichnyi klinichnyi tsentr
  • Kyirskyi Miskyi klinichnyi onkolohichnyi tsentr
  • KZ KOR Kyivskyi oblasnyi onkologichnyi dyspanser
  • Lvivskyi derzhavnyi onkologichnyi regionalnyi likuvalno diahnostychyi tsentr
  • Odeska oblasna klinichna likarnia
  • Poltavskyi oblasnyi klinichnyi onkolohichnyi dyspanser Pol
  • Zakarpatskyi oblasnyi klinichnyi onkodyspanser

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

Netupitant and Palonosetron+dexamethasone-cycle 1

Palonosetron+dexamethasone-cycle 1

Netupitant and Palonosetron+dexamethasone-multicycle extension

Palonosetron+dexamethasone-multicycle extension

Arm Description

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

Oral palonosetron 0.50 mg (Aloxi) with oral dexamethasone (20 mg) both given on Day 1, prior to each scheduled chemotherapy cycle

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

Oral palonosetron 0.50 mg (Aloxi) with oral dexamethasone (20 mg) both given on Day 1, prior to each scheduled chemotherapy cycle

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
April 19, 2011
Last Updated
November 19, 2014
Sponsor
Helsinn Healthcare SA
Collaborators
Parexel
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1. Study Identification

Unique Protocol Identification Number
NCT01339260
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 Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Helsinn Healthcare SA
Collaborators
Parexel

4. Oversight

Data Monitoring Committee
Yes

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chemotherapy-Induced Nausea and Vomiting

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1455 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Netupitant and Palonosetron+dexamethasone-cycle 1
Arm Type
Experimental
Arm Description
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
Arm Title
Palonosetron+dexamethasone-cycle 1
Arm Type
Active Comparator
Arm Description
Oral palonosetron 0.50 mg (Aloxi) with oral dexamethasone (20 mg) both given on Day 1, prior to each scheduled chemotherapy cycle
Arm Title
Netupitant and Palonosetron+dexamethasone-multicycle extension
Arm Type
Experimental
Arm Description
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
Arm Title
Palonosetron+dexamethasone-multicycle extension
Arm Type
Active Comparator
Arm Description
Oral palonosetron 0.50 mg (Aloxi) with oral dexamethasone (20 mg) both given on Day 1, prior to each scheduled chemotherapy cycle
Intervention Type
Drug
Intervention Name(s)
Netupitant and Palonosetron
Intervention Type
Drug
Intervention Name(s)
Palonosetron
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Primary Outcome Measure Information:
Title
Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication, at Cycle 1
Time Frame
25-120 hours
Secondary Outcome Measure Information:
Title
Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication at Cycle 1
Time Frame
0-24 hours
Title
Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication, at Cycle 1
Time Frame
0-120 hours

10. Eligibility

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

12. IPD Sharing Statement

Citations:
PubMed Identifier
30968588
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.
Results Reference
derived
PubMed Identifier
28285236
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.
Results Reference
derived

Learn more about this trial

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

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