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

Last updated: November 6, 2014
Sponsor: Helsinn Healthcare SA
Overall Status: Completed

Phase

3

Condition

Vomiting

Lactose Intolerance

Colic

Treatment

N/A

Clinical Study ID

NCT01376297
NETU-10-29
  • Ages > 18
  • All Genders

Study Summary

NETU-10-29 is a clinical study assessing safety of netupitant and palonosetron, two antiemetic drugs, both given with oral dexamethasone. The objective of the study is to evaluate if netupitant and palonosetron are safe when administered to prevent nausea and vomiting after administration of repeated cycles of chemotherapy.

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

Total Participants: 413
Study Start date:
July 01, 2011
Estimated Completion Date:

Connect with a study center

  • UMHAT "Dr. Georgi Stranski"

    Pleven, 5800
    Bulgaria

    Site Not Available

  • Complex Oncology Center - Shumen Ltd. [Oncology]

    Shumen, 9700
    Bulgaria

    Site Not Available

  • COC - Veliko Tarnovo Dept. Medical Oncology

    Tarnovo, 5000
    Bulgaria

    Site Not Available

  • Specialized Hospital for Active Treatment in Oncology "Dr. Marko Markov" Varna

    Varna, 9010
    Bulgaria

    Site Not Available

  • COC - Vratsa Dept. of Palliative Care

    Vratsa, 3000
    Bulgaria

    Site Not Available

  • Oblastni nemocnice Mlada Boleslav a.s., Onkologie

    Mlada Boleslav, 293 50
    Czech Republic

    Site Not Available

  • AVICENNUS s.r.o. Onkologie Nymburk

    Nymburk, 288 01
    Czech Republic

    Site Not Available

  • Fakultni nemocnice v Motole

    Praha 5, 150 06
    Czech Republic

    Site Not Available

  • Nemocnice Na Homolce, Oddeleni klinicke onkologie

    Praha 5, 150 30
    Czech Republic

    Site Not Available

  • Nemocnice Znojmo, p.o.

    Znojmo, 669 02
    Czech Republic

    Site 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
    Germany

    Site Not Available

  • Charite - Campus Benjamin Franklin (CBF)

    Berlin, 12200
    Germany

    Site Not Available

  • Medizinisches Versorgungszentrum für Hämatologie und Tumorerkrankungen, HIV/AIDS und Hepatitiden

    Berlin, 13347
    Germany

    Site Not Available

  • Universitaetsklinikum Carl Gustav Carus

    Dresden, 01307
    Germany

    Site Not Available

  • St. Johannes Hospital Medizinische Klinik II, Hämatologie, Onkologie und klinische Immunologie

    Duisburg, 47166
    Germany

    Site Not Available

  • Kliniken Essen-Mitte, Evang. Huyssens-Stiftung Klinik für internistische Onkologie und Hämatologie

    Essen,
    Germany

    Site Not Available

  • Praxis Fuer Interdisziplinaere Onkologie und Haematologie

    Freiburg, 79106
    Germany

    Site Not Available

  • Medizinische Hochschule, Zentrum für Innere Medizin, Klinik für Hämatologie, Hämostaseologie, Onkologie und Stammzelltransplantation

    Hannover, 30625
    Germany

    Site Not Available

  • Ärzteforum Hennigsdorf

    Hennigsdorf, 16761
    Germany

    Site Not Available

  • Praxis für Innere Medizin, Hämatologie und Internistische Onkologie

    Marburg, 35037
    Germany

    Site Not Available

  • Kliniken Maria Hilf GmbH, Krankenhaus St. Franziskus

    Mönchengladbach,
    Germany

    Site Not Available

  • Krankenhaus, Maria Hilf, St. Franziskus Innere Medizin

    Mönchengladbach, 41062
    Germany

    Site Not Available

  • OncoPRO GbR Dr. R. Dengler, Dr. A. Kröber

    Regensburg, 93053
    Germany

    Site Not Available

  • Országos Onkológiai Intézet, B. Belgyógyászati Osztály

    Budapest, 1122
    Hungary

    Site Not Available

  • Bekes Megyei Kepviselo-testulet Pandy Kalman Korhaz

    Gyula, 5700
    Hungary

    Site Not Available

  • Kaposi Mor Oktato Korhaz [Klinikai Onkologiai Centrum]

    Kaposvár,
    Hungary

    Site Not Available

  • Kaposi Mor Oktato Korhaz [Klinikai Onkologiai Centrum]

    Kaposvár, 7400
    Hungary

    Site Not Available

  • Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktatók

    Miskolc, 3501
    Hungary

    Site Not Available

  • Dr. Bugyi Istvan Korhaz [Oncology]

    Szentes, 6600
    Hungary

    Site Not Available

  • Fejér Megyei Szent György Kórház [Onkológiai Osztály]

    Székesfehérvár, 8000
    Hungary

    Site Not Available

  • Fejér Megyei Szent György Kórház [Onkológiai Osztály]

    Székesfehérvár, 8000
    Hungary

    Site Not Available

  • M.S Patel Cancer Hospital [Oncology]

    Ahmedabad, 388325
    India

    Site Not Available

  • Dr.Rai Memorial Medical centre

    Chennai, 600018
    India

    Site Not Available

  • Kumaran Hospital PVT Ltd

    Chennai, 600010
    India

    Site Not Available

  • Acharya Harihara Regional Cancer Centre [Oncology]

    Cuttack, 753007
    India

    Site Not Available

  • M.S Patel Cancer Hospital [Oncology]

    Gujarat, 388325
    India

    Site Not Available

  • Research Unit, The Karnatak cancer therapy & Research Instit

    Hubli, 580025
    India

    Site Not Available

  • S.M.S College And Hospital

    Jaipur, 302016
    India

    Site Not Available

  • Lucknow Cancer Institute [Oncology]

    Lucknow, 226001
    India

    Site Not Available

  • Apollo Speciality Hospital [Oncology]

    Madurai, 625020
    India

    Site Not Available

  • Lucknow Cancer Institute [Oncology]

    Uttar Pradesh, 226001
    India

    Site Not Available

  • King George Hospital [Medical Oncology]

    Visakhapatnam, 530002
    India

    Site Not Available

  • Bialostockie Centrum Onkologii im. M.Sklodowskiej-Curie im dr. E.Pileckiej z Pododdzialem Chemioterapii Dziennej

    Bialystok, 15-027
    Poland

    Site Not Available

  • Centrum Onkologii Ziemi Lubelskiej im.Sw.Jana z Dukli III Oddzial Onkologii Ginekologicznej, Radioterapii I Chemioterapii

    Lublin, 20-090
    Poland

    Site Not Available

  • Ginekologiczno-Położniczy Szpital Kliniczny UM w Poznaniu

    Poznan, 60-535
    Poland

    Site Not Available

  • Szpital Kliniczny Przemienienia Panskiego UM w Poznaniu

    Poznan, 60-569
    Poland

    Site Not Available

  • Wielkopolskie Centrum Onkologii im. M. Sklodowskiej-Curie i Onkologii Ginekologicznej

    Poznan, 61-866
    Poland

    Site Not Available

  • Szpital Specjalistyczny

    Prabuty, 82-550
    Poland

    Site Not Available

  • Szpital Rejonowy im. dr J. Rostka w Raciborzu

    Raciborz, 47-400
    Poland

    Site Not Available

  • GBUZ "Cheliabinsky Regional Oncology Dispensary"

    Chelyabinsk, 454087
    Russian Federation

    Site Not Available

  • GAUZ Republican Clinical Oncology Dispensary of Minzdrav of Republic of Tatarstan

    Kazan, 420029
    Russian Federation

    Site Not Available

  • Non-State healthcare Indtitution Central Clinical Hospital # 2 named after N.A. Semashko OAO "RZhD"

    Moscow, 129128
    Russian Federation

    Site Not Available

  • FBUZ Privolzhsky District Medical Center of FMBA

    Novgorod, 603001
    Russian Federation

    Site Not Available

  • Regional GUZ Orlovskiy Oncological Dispensary

    Orel, 302020
    Russian Federation

    Site Not Available

  • GBOU VPO "Saint-Petersburg State Medical University

    Saint-Petersburg, 197022
    Russian Federation

    Site Not Available

  • GUZ Leningradskiy Regional Oncology Dispensary

    St. Petersburg, 191104
    Russian Federation

    Site Not Available

  • GUZ Tula Regional Oncological Dispensary [Oncology]

    Tula, 300040
    Russian Federation

    Site Not Available

  • GBUZ Tyumen Regional Oncology Dispensary

    Tyumen, 625041
    Russian Federation

    Site Not Available

  • GBUZ Republican Clinical Oncology Dispensary of Minzdrav of Republic of Bashkortostan

    Ufa, 450054
    Russian Federation

    Site Not Available

  • Clinical Hospital Center Bezanijska Kosa

    Belgrade, 11000
    Serbia

    Site Not Available

  • Institute of oncology and radiology of Serbia

    Beograd, 11000
    Serbia

    Site Not Available

  • Clinical Center Kragujevac

    Kragujevac, 34000
    Serbia

    Site Not Available

  • Chernivtsi Regional Cancer Hospital [Outpatient Department]

    Chernivtsi, 58013
    Ukraine

    Site Not Available

  • Komunalnyi zaklad Miska bahatoprofilna klinichna likarnia #4

    Dnipropetrovks, 49102
    Ukraine

    Site Not Available

  • KZ MKL19, MOTsr, vd khimter [viddilennia khimioterapii]

    Dnipropetrovsk, 49100
    Ukraine

    Site Not Available

  • KKLPZ DnOPTsr [radio vd#3]

    Donetsk, 83092
    Ukraine

    Site Not Available

  • DU IMR AMNU [vd khemter]

    Kharkiv, 61024
    Ukraine

    Site Not Available

  • Poltavskyi oblasnyi klinichnyi onkolohichnyi dyspanser Pol

    Poltava, 36011
    Ukraine

    Site Not Available

  • Zakarpatskyi oblasnyi klinichnyi onkodyspanser [viddilennia

    Uzhgorod, 88014
    Ukraine

    Site Not Available

  • ZaOKOD [abdom vd]

    Zaporizhia, 69040
    Ukraine

    Site Not Available

  • Northwest Alabama Cancer Center PC

    Muscle Shoals,, Alabama 35661
    United States

    Site Not Available

  • East Valley Hematology and Oncology Medical Group

    Burbank, California 91505
    United States

    Site Not Available

  • American Institute of Research

    Los Angeles, California 90017
    United States

    Site Not Available

  • Veterans Administration New Jersey Health Care System

    East Orange, New Jersey 07018
    United States

    Site Not Available

  • Hematology Oncology Associates of Rockland

    Nyack, New York 10960
    United States

    Site Not Available

  • Hematology and Oncology Associates, Inc.

    Canton, Ohio 44708
    United States

    Site Not Available

  • Tri-County Hematology & Oncology Associates, Inc

    Massillon, Ohio 44646
    United States

    Site Not Available

  • Cancer Center at Memorial Hospital of RI

    Pawtucket, Rhode Island 02860
    United States

    Site Not Available

  • Spartanburg Regional Health Services

    Spartanburg, South Carolina 29303
    United States

    Site Not Available

  • South Texas Comrehensive Cancer Centers

    Corpus Christi, Texas 78405
    United States

    Site Not Available

  • MD Anderson Cancer Center

    Houston, Texas 77030-4009
    United States

    Site Not Available

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