Phase
Condition
Vomiting
Lactose Intolerance
Colic
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Signed written informed consent.
Naïve to cytotoxic chemotherapy. Previous biological or hormonal therapy is permitted.
Diagnosed with a malignant tumor.
If scheduled to receive repeated consecutive courses of chemotherapy, a single dose ofone or more of the following agents administered on Day 1 is allowed:
Highly emetogenic chemotherapy: any I.V. dose of cisplatin, mechlorethamine,streptozocin, cyclophosphamide more or equal to 1500 mg/m2, carmustine,dacarbazine;
Moderately emetogenic chemotherapy: any I.V. dose of oxaliplatin, carboplatin,epirubicin, idarubicin, ifosfamide, irinotecan, daunorubicin, doxorubicin,cyclophosphamide I.V. (less than 1500 mg/m2), cytarabine I.V. (more than 1 g/m2),azacidine, alemtuzumab, bendamustine, or clofarabine.
If scheduled to receive combination regimens, the most emetogenic agent is to be givenas first on Day 1 and the infusion must be completed within 6 hours.
If scheduled to receive chemotherapy agents of minimal to low emetogenic potential,they are to be given on Day 1 following the most emetogenic agent or on any subsequentstudy day.
ECOG Performance Status of 0, 1, or 2
Female patients of either non-childbearing potential or child-bearing potential with acommitment to use contraceptive methods throughout the clinical trial
Hematologic and metabolic status adequate for receiving a moderately emetogenicregimen based on laboratory criteria (Total Neutrophils,Platelets, Bilirubin, Liverenzymes, Serum Creatinine or Creatinine Clearance)
Exclusion
Exclusion Criteria:
If female, lactating or pregnant
Current use of illicit drugs or current evidence of alcohol abuse.
Scheduled to receive either 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).
Scheduled to receive moderately or highly emetogenic chemotherapy from Day 2 to Day 5following Day 1 chemotherapy administration.
Active infection or uncontrolled disease except for malignancy that may poseunwarranted risks in administering the study drugs to the patient.
Known hypersensitivity or contraindication to 5-HT3 receptor antagonists ordexamethasone.
Previously received an NK1 receptor antagonist
Participation in a clinical trial involving oral netupitant administered incombination with palonosetron.
Any investigational drugs taken within 4 weeks prior to Day 1 of cycle 1, and/or isscheduled to receive any investigational drug during the study.
Systemic corticosteroid therapy at any dose within 72 hours prior to Day 1 of cycle 1.Topical and inhaled corticosteroids with a steroid dose of less or equal to 10 mg ofprednisone daily or its equivalent are permitted. Non-study drug dexamethasone aspre-medication in patients scheduled to receive taxanes is allowed.
Scheduled to receive bone marrow transplantation and/or stem cell rescue therapy.
Scheduled to receive any strong or moderate inhibitor of CYP3A4 or its intake within 1week 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 incompleteright bundle branch block.
History of risk factors for Torsade de Point (heart failure, hypokalemia, familyhistory of Long QT Syndrome).
Severe cardiovascular diseases within 3 months prior to Day 1, including myocardialinfarction, unstable angina pectoris, significant valvular or pericardial disease,history of ventricular tachycardia, symptomatic Congestive Heart Failure and severeuncontrolled arterial hypertension.
Any illness or condition that, in the opinion of the investigator, may confound theresults of the study or pose unwarranted risks in administering the investigationalproduct to the patient.
Concurrent medical condition that would preclude administration of dexamethasone for 4days such as systemic fungal infection or uncontrolled diabetes.
Study Design
Connect with a study center
UMHAT "Dr. Georgi Stranski"
Pleven, 5800
BulgariaSite Not Available
Complex Oncology Center - Shumen Ltd. [Oncology]
Shumen, 9700
BulgariaSite Not Available
COC - Veliko Tarnovo Dept. Medical Oncology
Tarnovo, 5000
BulgariaSite Not Available
Specialized Hospital for Active Treatment in Oncology "Dr. Marko Markov" Varna
Varna, 9010
BulgariaSite Not Available
COC - Vratsa Dept. of Palliative Care
Vratsa, 3000
BulgariaSite Not Available
Oblastni nemocnice Mlada Boleslav a.s., Onkologie
Mlada Boleslav, 293 50
Czech RepublicSite Not Available
AVICENNUS s.r.o. Onkologie Nymburk
Nymburk, 288 01
Czech RepublicSite Not Available
Fakultni nemocnice v Motole
Praha 5, 150 06
Czech RepublicSite Not Available
Nemocnice Na Homolce, Oddeleni klinicke onkologie
Praha 5, 150 30
Czech RepublicSite Not Available
Nemocnice Znojmo, p.o.
Znojmo, 669 02
Czech RepublicSite Not Available
Gemeinschaftspraxis, Dr. Med O.Brundler und B.Heinreich, PD Dr. med M.Bangerter Fachärzte für Innere Medizin, Hämatologie und internistische Onkologie
Augsburg, 86150
GermanySite Not Available
Charite - Campus Benjamin Franklin (CBF)
Berlin, 12200
GermanySite Not Available
Medizinisches Versorgungszentrum für Hämatologie und Tumorerkrankungen, HIV/AIDS und Hepatitiden
Berlin, 13347
GermanySite Not Available
Universitaetsklinikum Carl Gustav Carus
Dresden, 01307
GermanySite Not Available
St. Johannes Hospital Medizinische Klinik II, Hämatologie, Onkologie und klinische Immunologie
Duisburg, 47166
GermanySite Not Available
Kliniken Essen-Mitte, Evang. Huyssens-Stiftung Klinik für internistische Onkologie und Hämatologie
Essen,
GermanySite Not Available
Praxis Fuer Interdisziplinaere Onkologie und Haematologie
Freiburg, 79106
GermanySite Not Available
Medizinische Hochschule, Zentrum für Innere Medizin, Klinik für Hämatologie, Hämostaseologie, Onkologie und Stammzelltransplantation
Hannover, 30625
GermanySite Not Available
Ärzteforum Hennigsdorf
Hennigsdorf, 16761
GermanySite Not Available
Praxis für Innere Medizin, Hämatologie und Internistische Onkologie
Marburg, 35037
GermanySite Not Available
Kliniken Maria Hilf GmbH, Krankenhaus St. Franziskus
Mönchengladbach,
GermanySite Not Available
Krankenhaus, Maria Hilf, St. Franziskus Innere Medizin
Mönchengladbach, 41062
GermanySite Not Available
OncoPRO GbR Dr. R. Dengler, Dr. A. Kröber
Regensburg, 93053
GermanySite Not Available
Országos Onkológiai Intézet, B. Belgyógyászati Osztály
Budapest, 1122
HungarySite Not Available
Bekes Megyei Kepviselo-testulet Pandy Kalman Korhaz
Gyula, 5700
HungarySite Not Available
Kaposi Mor Oktato Korhaz [Klinikai Onkologiai Centrum]
Kaposvár,
HungarySite Not Available
Kaposi Mor Oktato Korhaz [Klinikai Onkologiai Centrum]
Kaposvár, 7400
HungarySite Not Available
Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktatók
Miskolc, 3501
HungarySite Not Available
Dr. Bugyi Istvan Korhaz [Oncology]
Szentes, 6600
HungarySite Not Available
Fejér Megyei Szent György Kórház [Onkológiai Osztály]
Székesfehérvár, 8000
HungarySite Not Available
Fejér Megyei Szent György Kórház [Onkológiai Osztály]
Székesfehérvár, 8000
HungarySite Not Available
M.S Patel Cancer Hospital [Oncology]
Ahmedabad, 388325
IndiaSite Not Available
Dr.Rai Memorial Medical centre
Chennai, 600018
IndiaSite Not Available
Kumaran Hospital PVT Ltd
Chennai, 600010
IndiaSite Not Available
Acharya Harihara Regional Cancer Centre [Oncology]
Cuttack, 753007
IndiaSite Not Available
M.S Patel Cancer Hospital [Oncology]
Gujarat, 388325
IndiaSite Not Available
Research Unit, The Karnatak cancer therapy & Research Instit
Hubli, 580025
IndiaSite Not Available
S.M.S College And Hospital
Jaipur, 302016
IndiaSite Not Available
Lucknow Cancer Institute [Oncology]
Lucknow, 226001
IndiaSite Not Available
Apollo Speciality Hospital [Oncology]
Madurai, 625020
IndiaSite Not Available
Lucknow Cancer Institute [Oncology]
Uttar Pradesh, 226001
IndiaSite Not Available
King George Hospital [Medical Oncology]
Visakhapatnam, 530002
IndiaSite Not Available
Bialostockie Centrum Onkologii im. M.Sklodowskiej-Curie im dr. E.Pileckiej z Pododdzialem Chemioterapii Dziennej
Bialystok, 15-027
PolandSite Not Available
Centrum Onkologii Ziemi Lubelskiej im.Sw.Jana z Dukli III Oddzial Onkologii Ginekologicznej, Radioterapii I Chemioterapii
Lublin, 20-090
PolandSite Not Available
Ginekologiczno-Położniczy Szpital Kliniczny UM w Poznaniu
Poznan, 60-535
PolandSite Not Available
Szpital Kliniczny Przemienienia Panskiego UM w Poznaniu
Poznan, 60-569
PolandSite Not Available
Wielkopolskie Centrum Onkologii im. M. Sklodowskiej-Curie i Onkologii Ginekologicznej
Poznan, 61-866
PolandSite Not Available
Szpital Specjalistyczny
Prabuty, 82-550
PolandSite Not Available
Szpital Rejonowy im. dr J. Rostka w Raciborzu
Raciborz, 47-400
PolandSite Not Available
GBUZ "Cheliabinsky Regional Oncology Dispensary"
Chelyabinsk, 454087
Russian FederationSite Not Available
GAUZ Republican Clinical Oncology Dispensary of Minzdrav of Republic of Tatarstan
Kazan, 420029
Russian FederationSite Not Available
Non-State healthcare Indtitution Central Clinical Hospital # 2 named after N.A. Semashko OAO "RZhD"
Moscow, 129128
Russian FederationSite Not Available
FBUZ Privolzhsky District Medical Center of FMBA
Novgorod, 603001
Russian FederationSite Not Available
Regional GUZ Orlovskiy Oncological Dispensary
Orel, 302020
Russian FederationSite Not Available
GBOU VPO "Saint-Petersburg State Medical University
Saint-Petersburg, 197022
Russian FederationSite Not Available
GUZ Leningradskiy Regional Oncology Dispensary
St. Petersburg, 191104
Russian FederationSite Not Available
GUZ Tula Regional Oncological Dispensary [Oncology]
Tula, 300040
Russian FederationSite Not Available
GBUZ Tyumen Regional Oncology Dispensary
Tyumen, 625041
Russian FederationSite Not Available
GBUZ Republican Clinical Oncology Dispensary of Minzdrav of Republic of Bashkortostan
Ufa, 450054
Russian FederationSite Not Available
Clinical Hospital Center Bezanijska Kosa
Belgrade, 11000
SerbiaSite Not Available
Institute of oncology and radiology of Serbia
Beograd, 11000
SerbiaSite Not Available
Clinical Center Kragujevac
Kragujevac, 34000
SerbiaSite Not Available
Chernivtsi Regional Cancer Hospital [Outpatient Department]
Chernivtsi, 58013
UkraineSite Not Available
Komunalnyi zaklad Miska bahatoprofilna klinichna likarnia #4
Dnipropetrovks, 49102
UkraineSite Not Available
KZ MKL19, MOTsr, vd khimter [viddilennia khimioterapii]
Dnipropetrovsk, 49100
UkraineSite Not Available
KKLPZ DnOPTsr [radio vd#3]
Donetsk, 83092
UkraineSite Not Available
DU IMR AMNU [vd khemter]
Kharkiv, 61024
UkraineSite Not Available
Poltavskyi oblasnyi klinichnyi onkolohichnyi dyspanser Pol
Poltava, 36011
UkraineSite Not Available
Zakarpatskyi oblasnyi klinichnyi onkodyspanser [viddilennia
Uzhgorod, 88014
UkraineSite Not Available
ZaOKOD [abdom vd]
Zaporizhia, 69040
UkraineSite Not Available
Northwest Alabama Cancer Center PC
Muscle Shoals,, Alabama 35661
United StatesSite Not Available
East Valley Hematology and Oncology Medical Group
Burbank, California 91505
United StatesSite Not Available
American Institute of Research
Los Angeles, California 90017
United StatesSite Not Available
Veterans Administration New Jersey Health Care System
East Orange, New Jersey 07018
United StatesSite Not Available
Hematology Oncology Associates of Rockland
Nyack, New York 10960
United StatesSite Not Available
Hematology and Oncology Associates, Inc.
Canton, Ohio 44708
United StatesSite Not Available
Tri-County Hematology & Oncology Associates, Inc
Massillon, Ohio 44646
United StatesSite Not Available
Cancer Center at Memorial Hospital of RI
Pawtucket, Rhode Island 02860
United StatesSite Not Available
Spartanburg Regional Health Services
Spartanburg, South Carolina 29303
United StatesSite Not Available
South Texas Comrehensive Cancer Centers
Corpus Christi, Texas 78405
United StatesSite Not Available
MD Anderson Cancer Center
Houston, Texas 77030-4009
United StatesSite Not Available
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