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Chemotherapy-Induced Nausea and VomitingPhase 3NCT01376297

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

A Phase 3 study testing Netupitant and Palonosetron, Aprepitant and Palonosetron in people with Chemotherapy-Induced Nausea and Vomiting, run by Helsinn Healthcare SA at 75 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chemotherapy-Induced Nausea and Vomiting
What is being tested?
Netupitant and Palonosetron, Aprepitant and Palonosetron
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
413 participants
Where
75 sitesin 10 countries
Study dates
Jul 2011to Sep 2012
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 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.
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  • 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)

Who cannot join

  • 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 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.
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  • 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.

Trial locations and contacts

75 sites in 10 countries.

75 sites in 10 countries

United States11 sites

  • East Valley Hematology and Oncology Medical Group

    Burbank, California, 91505

  • Hematology and Oncology Associates, Inc.

    Canton, Ohio, 44708

  • South Texas Comrehensive Cancer Centers

    Corpus Christi, Texas, 78405

  • Veterans Administration New Jersey Health Care System

    East Orange, New Jersey, 07018

  • MD Anderson Cancer Center

    Houston, Texas, 77030-4009

  • American Institute of Research

    Los Angeles, California, 90017

  • Tri-County Hematology & Oncology Associates, Inc

    Massillon, Ohio, 44646

  • Northwest Alabama Cancer Center PC

    Muscle Shoals, Alabama, 35661

  • Hematology Oncology Associates of Rockland

    Nyack, New York, 10960

  • Cancer Center at Memorial Hospital of RI

    Pawtucket, Rhode Island, 02860

  • Spartanburg Regional Health Services

    Spartanburg, South Carolina, 29303

Other trials in United States

Germany11 sites

  • Gemeinschaftspraxis, Dr. Med O.Brundler und B.Heinreich, PD Dr. med M.Bangerter Fachärzte für Innere Medizin, Hämatologie und internistische Onkologie

    Augsburg, 86150

  • Charite - Campus Benjamin Franklin (CBF)

    Berlin, 12200

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

    Berlin, 13347

  • Universitaetsklinikum Carl Gustav Carus

    Dresden, 01307

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

    Duisburg, 47166

  • Praxis Fuer Interdisziplinaere Onkologie und Haematologie

    Freiburg im Breisgau, 79106

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

    Hanover, 30625

  • Ärzteforum Hennigsdorf

    Hennigsdorf, 16761

  • Praxis für Innere Medizin, Hämatologie und Internistische Onkologie

    Marburg, 35037

  • Krankenhaus, Maria Hilf, St. Franziskus Innere Medizin

    Mönchengladbach, 41062

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

    Regensburg, 93053

Other trials in Germany

Russia10 sites

  • GBUZ "Cheliabinsky Regional Oncology Dispensary"

    Chelyabinsk, 454087

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

    Kazan', 420029

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

    Moscow, 129128

  • Regional GUZ Orlovskiy Oncological Dispensary

    Oryol, 302020

  • GUZ Leningradskiy Regional Oncology Dispensary

    Saint Petersburg, 191104

  • GBOU VPO "Saint-Petersburg State Medical University

    Saint Petersburg, 197022

  • GUZ Tula Regional Oncological Dispensary [Oncology]

    Tula, 300040

  • GBUZ Tyumen Regional Oncology Dispensary

    Tyumen, 625041

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

    Ufa, 450054

  • FBUZ Privolzhsky District Medical Center of FMBA

    Velikiy Novgorod, 603001

Other trials in Russia

India9 sites

  • Kumaran Hospital PVT Ltd

    Chennai, 600010

  • Dr.Rai Memorial Medical centre

    Chennai, 600018

  • Acharya Harihara Regional Cancer Centre [Oncology]

    Cuttack, 753007

  • M.S Patel Cancer Hospital [Oncology]

    Gujarat, 388325

  • Research Unit, The Karnatak cancer therapy & Research Instit

    Hubli, 580025

  • S.M.S College And Hospital

    Jaipur, 302016

  • Apollo Speciality Hospital [Oncology]

    Madurai, 625020

  • Lucknow Cancer Institute [Oncology]

    Uttar Pradesh, 226001

  • King George Hospital [Medical Oncology]

    Visakhapatnam, 530002

Other trials in India

Ukraine8 sites

  • Chernivtsi Regional Cancer Hospital [Outpatient Department]

    Chernivtsi, 58013

  • Komunalnyi zaklad Miska bahatoprofilna klinichna likarnia #4

    Dnipropetrovks, 49102

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

    Dnipropetrovsk, 49100

  • KKLPZ DnOPTsr [radio vd#3]

    Donetsk, 83092

  • DU IMR AMNU [vd khemter]

    Kharkiv, 61024

  • Poltavskyi oblasnyi klinichnyi onkolohichnyi dyspanser Pol

    Poltava, 36011

  • Zakarpatskyi oblasnyi klinichnyi onkodyspanser [viddilennia

    Uzhhorod, 88014

  • ZaOKOD [abdom vd]

    Zaporizhia, 69040

Other trials in Ukraine

Poland7 sites

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

    Bialystok, 15-027

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

    Lublin, 20-090

  • Ginekologiczno-Położniczy Szpital Kliniczny UM w Poznaniu

    Poznan, 60-535

  • Szpital Kliniczny Przemienienia Panskiego UM w Poznaniu

    Poznan, 60-569

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

    Poznan, 61-866

  • Szpital Specjalistyczny

    Prabuty, 82-550

  • Szpital Rejonowy im. dr J. Rostka w Raciborzu

    Racibórz, 47-400

Other trials in Poland

Hungary6 sites

  • Országos Onkológiai Intézet, B. Belgyógyászati Osztály

    Budapest, 1122

  • Bekes Megyei Kepviselo-testulet Pandy Kalman Korhaz

    Gyula, 5700

  • Kaposi Mor Oktato Korhaz [Klinikai Onkologiai Centrum]

    Kaposvár, 7400

  • Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktatók

    Miskolc, 3501

  • Fejér Megyei Szent György Kórház [Onkológiai Osztály]

    Székesfehérvár, 8000

  • Dr. Bugyi Istvan Korhaz [Oncology]

    Szentes, 6600

Other trials in Hungary

Bulgaria5 sites

  • UMHAT "Dr. Georgi Stranski"

    Pleven, 5800

  • Complex Oncology Center - Shumen Ltd. [Oncology]

    Shumen, 9700

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

    Varna, 9010

  • COC - Veliko Tarnovo Dept. Medical Oncology

    Veliko Tarnovo, 5000

  • COC - Vratsa Dept. of Palliative Care

    Vratsa, 3000

Other trials in Bulgaria

Czechia5 sites

  • Oblastni nemocnice Mlada Boleslav a.s., Onkologie

    Mladá Boleslav, 293 50

  • AVICENNUS s.r.o. Onkologie Nymburk

    Nymburk, 288 01

  • Fakultni nemocnice v Motole

    Prague, 150 06

  • Nemocnice Na Homolce, Oddeleni klinicke onkologie

    Prague, 150 30

  • Nemocnice Znojmo, p.o.

    Znojmo, 669 02

Other trials in Czechia

Serbia3 sites

  • Clinical Hospital Center Bezanijska Kosa

    Belgrade, 11000

  • Institute of oncology and radiology of Serbia

    Belgrade, 11000

  • Clinical Center Kragujevac

    Kragujevac, 34000

Other trials in Serbia

About this study

Official title: A Phase III, Multicenter, Randomized, Double-blind, Unbalanced (3:1) Active Control Study to Assess the Safety and Describe the Efficacy of Netupitant and Palonosetron for the Prevention of Chemotherapy-induced Nausea and Vomiting in Repeated Chemotherapy Cycles.

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.

Being tested
Netupitant and Palonosetron, Aprepitant, Palonosetron, Dexamethasone
Medical subject headings
Vomiting

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Netupitant and PalonosetronDrug

  • AprepitantDrug

  • PalonosetronDrug

  • DexamethasoneDrug

Study groups in NCT01376297
Study groupRoleWhat they receive
Netupitant and Palonosetron plus dexamethasoneExperimentalOral netupitant/palonosetron (300 mg/0.50 mg) hard capsule (on Day 1) with oral dexamethasone prior to each scheduled chemotherapy cycle
Receives: Drug: Netupitant and Palonosetron; Drug: Dexamethasone
Aprepitant and Palonosetron plus dexamethasoneActive comparatorOral 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.
Receives: Drug: Aprepitant; Drug: Palonosetron; Drug: Dexamethasone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Patients With Adverse Events

    This was a safety study where Adverse Events is the primary outcome (defined by the current ICH Guideline for Good Clinical Practice). Patients were randomized according to a 3:1 ratio (netupitant/palonosetron:aprepitant/palonosetron). No formal comparison was planned, the presence of a control in the same patient population helped interpret any unexpected safety finding in the experimental arm.The number of patients was estimated in order to have more than 100 patients treated with the netupitant/palonosetron comination for up to at least six cycles. Based on 100 patients, if a given AE is not observed, an AE incidence of 3% or greater can be excluded with 95% confidence.

    Measured: Participants will be followed for the duration of the chemotherapy, an expected average duration of up to 24 weeks assuming 6 chemotherapy cycles given every 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jun 2011 (estimated)
  2. Study startJul 2011
  3. Primary completionSep 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
413 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01376297
Sponsor's protocol ID
NETU-10-29
Status last verified
Nov 2014
First submitted
16 Jun 2011
Last updated
17 Nov 2014
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 30968588

  • 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.

    PubMed 28285236

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Netupitant and Palonosetron, Aprepitant and Palonosetron in people with Chemotherapy-Induced Nausea and Vomiting, run by Helsinn Healthcare SA at 75 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 75 sites in United States, Germany, Russia, India, Ukraine and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Nov 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Patients With Adverse Events (time frame: Participants will be followed for the duration of the chemotherapy, an expected average duration of up to 24 weeks assuming 6 chemotherapy cycles given every 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01376297, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2014.

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