A Safety Study of Oral Netupitant and Palonosetron for the Prevention of Nausea and Vomiting
NCT ID: NCT01376297
Last Updated: 2014-11-17
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
413 participants
INTERVENTIONAL
2011-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Netupitant and Palonosetron plus dexamethasone
Oral netupitant/palonosetron (300 mg/0.50 mg) hard capsule (on Day 1) with oral dexamethasone prior to each scheduled chemotherapy cycle
Netupitant and Palonosetron
Dexamethasone
Aprepitant and Palonosetron plus dexamethasone
Oral aprepitant hard capsule 125 mg (on Day 1) + 80 mg daily (for the following two days) and oral palonosetron soft capsule 0.50 mg (on Day 1) given with oral dexamethasone at each scheduled chemotherapy cycle.
Aprepitant
Palonosetron
Dexamethasone
Interventions
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Netupitant and Palonosetron
Aprepitant
Palonosetron
Dexamethasone
Eligibility Criteria
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Inclusion Criteria
* 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 of one 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 given as 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 subsequent study 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)
Exclusion Criteria
* 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 5 following Day 1 chemotherapy administration.
* Active infection or uncontrolled disease except for malignancy that may 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. Topical and inhaled corticosteroids with a steroid dose of less or equal to 10 mg of prednisone daily or its equivalent are permitted. Non-study drug dexamethasone as pre-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 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 within 3 months prior to Day 1, including myocardial infarction, unstable angina pectoris, significant valvular or pericardial disease, history of ventricular tachycardia, symptomatic Congestive Heart Failure 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 for 4 days such as systemic fungal infection or uncontrolled diabetes.
18 Years
ALL
No
Sponsors
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Parexel
INDUSTRY
Helsinn Healthcare SA
INDUSTRY
Responsible Party
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Locations
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Northwest Alabama Cancer Center PC
Muscle Shoals, Alabama, United States
East Valley Hematology and Oncology Medical Group
Burbank, California, United States
American Institute of Research
Los Angeles, California, United States
Veterans Administration New Jersey Health Care System
East Orange, New Jersey, United States
Hematology Oncology Associates of Rockland
Nyack, New York, United States
Hematology and Oncology Associates, Inc.
Canton, Ohio, United States
Tri-County Hematology & Oncology Associates, Inc
Massillon, Ohio, United States
Cancer Center at Memorial Hospital of RI
Pawtucket, Rhode Island, United States
Spartanburg Regional Health Services
Spartanburg, South Carolina, United States
South Texas Comrehensive Cancer Centers
Corpus Christi, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
UMHAT "Dr. Georgi Stranski"
Pleven, , Bulgaria
Complex Oncology Center - Shumen Ltd. [Oncology]
Shumen, , Bulgaria
Specialized Hospital for Active Treatment in Oncology "Dr. Marko Markov" Varna
Varna, , Bulgaria
COC - Veliko Tarnovo Dept. Medical Oncology
Veliko Tarnovo, , Bulgaria
COC - Vratsa Dept. of Palliative Care
Vratsa, , Bulgaria
Oblastni nemocnice Mlada Boleslav a.s., Onkologie
Mladá Boleslav, , Czechia
AVICENNUS s.r.o. Onkologie Nymburk
Nymburk, , Czechia
Fakultni nemocnice v Motole
Prague, , Czechia
Nemocnice Na Homolce, Oddeleni klinicke onkologie
Prague, , Czechia
Nemocnice Znojmo, p.o.
Znojmo, , Czechia
Gemeinschaftspraxis, Dr. Med O.Brundler und B.Heinreich, PD Dr. med M.Bangerter Fachärzte für Innere Medizin, Hämatologie und internistische Onkologie
Augsburg, , Germany
Charite - Campus Benjamin Franklin (CBF)
Berlin, , Germany
Medizinisches Versorgungszentrum für Hämatologie und Tumorerkrankungen, HIV/AIDS und Hepatitiden
Berlin, , Germany
Universitaetsklinikum Carl Gustav Carus
Dresden, , Germany
St. Johannes Hospital Medizinische Klinik II, Hämatologie, Onkologie und klinische Immunologie
Duisburg, , Germany
Praxis Fuer Interdisziplinaere Onkologie und Haematologie
Freiburg im Breisgau, , Germany
Medizinische Hochschule, Zentrum für Innere Medizin, Klinik für Hämatologie, Hämostaseologie, Onkologie und Stammzelltransplantation
Hanover, , Germany
Ärzteforum Hennigsdorf
Hennigsdorf, , Germany
Praxis für Innere Medizin, Hämatologie und Internistische Onkologie
Marburg, , Germany
Krankenhaus, Maria Hilf, St. Franziskus Innere Medizin
Mönchengladbach, , Germany
OncoPRO GbR Dr. R. Dengler, Dr. A. Kröber
Regensburg, , Germany
Országos Onkológiai Intézet, B. Belgyógyászati Osztály
Budapest, , Hungary
Bekes Megyei Kepviselo-testulet Pandy Kalman Korhaz
Gyula, , Hungary
Kaposi Mor Oktato Korhaz [Klinikai Onkologiai Centrum]
Kaposvár, , Hungary
Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktatók
Miskolc, , Hungary
Dr. Bugyi Istvan Korhaz [Oncology]
Szentes, , Hungary
Fejér Megyei Szent György Kórház [Onkológiai Osztály]
Székesfehérvár, , Hungary
Kumaran Hospital PVT Ltd
Chennai, , India
Dr.Rai Memorial Medical centre
Chennai, , India
Acharya Harihara Regional Cancer Centre [Oncology]
Cuttack, , India
M.S Patel Cancer Hospital [Oncology]
Gujarat, , India
Research Unit, The Karnatak cancer therapy & Research Instit
Hubli, , India
S.M.S College And Hospital
Jaipur, , India
Apollo Speciality Hospital [Oncology]
Madurai, , India
Lucknow Cancer Institute [Oncology]
Uttar Pradesh, , India
King George Hospital [Medical Oncology]
Visakhapatnam, , India
Bialostockie Centrum Onkologii im. M.Sklodowskiej-Curie im dr. E.Pileckiej z Pododdzialem Chemioterapii Dziennej
Bialystok, , Poland
Centrum Onkologii Ziemi Lubelskiej im.Sw.Jana z Dukli III Oddzial Onkologii Ginekologicznej, Radioterapii I Chemioterapii
Lublin, , Poland
Ginekologiczno-Położniczy Szpital Kliniczny UM w Poznaniu
Poznan, , Poland
Szpital Kliniczny Przemienienia Panskiego UM w Poznaniu
Poznan, , Poland
Wielkopolskie Centrum Onkologii im. M. Sklodowskiej-Curie i Onkologii Ginekologicznej
Poznan, , Poland
Szpital Specjalistyczny
Prabuty, , Poland
Szpital Rejonowy im. dr J. Rostka w Raciborzu
Racibórz, , Poland
GBUZ "Cheliabinsky Regional Oncology Dispensary"
Chelyabinsk, , Russia
GAUZ Republican Clinical Oncology Dispensary of Minzdrav of Republic of Tatarstan
Kazan', , Russia
Non-State healthcare Indtitution Central Clinical Hospital # 2 named after N.A. Semashko OAO "RZhD"
Moscow, , Russia
Regional GUZ Orlovskiy Oncological Dispensary
Oryol, , Russia
GUZ Leningradskiy Regional Oncology Dispensary
Saint Petersburg, , Russia
GBOU VPO "Saint-Petersburg State Medical University
Saint Petersburg, , Russia
GUZ Tula Regional Oncological Dispensary [Oncology]
Tula, , Russia
GBUZ Tyumen Regional Oncology Dispensary
Tyumen, , Russia
GBUZ Republican Clinical Oncology Dispensary of Minzdrav of Republic of Bashkortostan
Ufa, , Russia
FBUZ Privolzhsky District Medical Center of FMBA
Veliky Novgorod, , Russia
Clinical Hospital Center Bezanijska Kosa
Belgrade, , Serbia
Institute of oncology and radiology of Serbia
Belgrade, , Serbia
Clinical Center Kragujevac
Kragujevac, , Serbia
Chernivtsi Regional Cancer Hospital [Outpatient Department]
Chernivtsi, , Ukraine
Komunalnyi zaklad Miska bahatoprofilna klinichna likarnia #4
Dnipropetrovks, , Ukraine
KZ MKL19, MOTsr, vd khimter [viddilennia khimioterapii]
Dnipropetrovsk, , Ukraine
KKLPZ DnOPTsr [radio vd#3]
Donetsk, , Ukraine
DU IMR AMNU [vd khemter]
Kharkiv, , Ukraine
Poltavskyi oblasnyi klinichnyi onkolohichnyi dyspanser Pol
Poltava, , Ukraine
Zakarpatskyi oblasnyi klinichnyi onkodyspanser [viddilennia
Uzhhorod, , Ukraine
ZaOKOD [abdom vd]
Zaporizhia, , Ukraine
Countries
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References
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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.
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.
Other Identifiers
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NETU-10-29
Identifier Type: -
Identifier Source: org_study_id