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Chemotherapy-Induced Nausea and VomitingPhase 3NCT02517021

A Safety Study of Intravenous Pro-Netupitant and Palonosetron Combination for the Prevention of Nausea and Vomiting

A Phase 3 study testing Pro-netupitant/Palonosetron, Netupitant/Palonosetron and Dexamethasone in people with Chemotherapy-Induced Nausea and Vomiting, run by Helsinn Healthcare SA at 74 sites in 12 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

NEPA-15-18 is a clinical study assessing safety of pro-netupitant and palonosetron, two antiemetic drugs, given with oral dexamethasone. The objective of the study is to evaluate if pro-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?
Pro-netupitant/Palonosetron, Netupitant/Palonosetron and Dexamethasone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
405 participants
Where
74 sitesin 12 countries
Study dates
Nov 2015to Aug 2016
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

  • Cycle 1
  • Signed written informed consent
  • Histologically or cytologically confirmed solid tumor malignancy.
  • Naïve to cytotoxic chemotherapy. Previous biological or hormonal therapy will be permitted.
  • Scheduled to receive at least 4 repeated consecutive cycles of the following highly emetogenic reference chemotherapies (HEC), alone or in combination with other chemotherapeutic agents on Day 1: cisplatin administered as a single IV dose of ≥ 70 mg/m2; cyclophosphamide ≥1500 mg/m2; carmustine (BCNU) >250mg/m2; dacarbazine (DTIC); mechloretamine (nitrogen mustard)
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2 .
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  • If a patient is female, she shall be of non-childbearing potential or of childbearing potential using reliable contraceptive measures and having a negative urine pregnancy test.
  • Hematologic and metabolic status adequate for receiving an highly emetogenic regimen based on laboratory criteria (Total Neutrophils,Platelets, Bilirubin, Liver enzymes, Serum Creatinine or Creatinine Clearance)
  • Able to read, understand, follow the study procedure and complete patient diary.
  • Cycles 2 to 4:
  • The following inclusion criteria must be checked prior to inclusion at each repeated cycle:
  • Participation in the study during the next cycle of chemotherapy is considered appropriate by the Investigator and does not pose unwarranted risk to the patient.
  • Scheduled to receive the same chemotherapy regimen as Cycle 1 or one of the reference chemotherapies as defined in Inclusion criterion 5 for Cycle 1.
  • If a patient is female, she shall be of non--childbearing potential or of childbearing potential using reliable contraceptive measures and having a negative urine pregnancy test.
  • Adequate hematologic and metabolic status according to the Investigator's opinion.

Who cannot join

  • Cycle 1
  • Lactating woman.
  • Active infection or uncontrolled disease except for malignancy that may pose unwarranted risks in administering the study drugs to the patient.
  • Current use of illicit drugs or current evidence of alcohol abuse.
  • Scheduled to receive moderately or highly emetogenic chemotherapies from Day 2 to Day 5.
  • Received or is scheduled to receive radiation therapy to the abdomen or the pelvis within 1 week prior to the start of the reference chemotherapy administration on Day 1 or between Days 1 to 5.
Show all 32Show fewer
  • Any vomiting, retching, or nausea (grade ≥ 1 as defined by National Cancer Institute) within 24 hours prior to the start of the reference chemotherapy administration on Day 1.
  • Symptomatic primary or metastatic CNS malignancy.
  • Known hypersensitivity or contraindication to 5-HT3 receptor antagonists, to dexamethasone or to NK-1 receptor antagonists.
  • Known contraindication to the IV administration of 50 mL 5% glucose solution.
  • Previously received an NK-1 receptor antagonist.
  • Participation in a previous clinical trial involving IV pro-netupitant or oral netupitant administered alone or in combination with palonosetron.
  • Any investigational drugs (other than those given in this study) taken within 4 weeks prior to Day 1, and/or is scheduled to receive any investigational drug during the present study.
  • Systemic corticosteroid therapy at any dose within 72 hours prior to the start of reference chemotherapy administration on Day 1. Topical and inhaled corticosteroids are permitted.
  • 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 within 1 week prior to Day 1: terfenadine, cisapride, astemizole, pimozide.
  • Received within 4 weeks prior to Day 1 or scheduled to receive any CYP3A4 inducer.
  • Any medication with known or potential antiemetic activity within 24 hours prior to the start of reference chemotherapy administration on Day 1 of Cycle 1, including but not limited to 5-HT3 receptor antagonists and NK-1 receptor antagonists
  • History or predisposition to cardiac conduction abnormalities, except for incomplete right bundle branch block
  • History of Torsade de Point or known history of risk factors for Torsade de Point (heart failure, hypokalemia, family history of Long QT Syndrome).
  • Severe cardiovascular diseases diagnosed within 3 months prior to Day 1 of first cycle, including myocardial infarction, 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.
  • Cycles 2 to 4:
  • The following exclusion criteria must be checked prior to inclusion in each repeated cycle:
  • Lactating woman.
  • Active infection or uncontrolled disease except for malignancy that may pose unwarranted risks in administering the study drugs to the patient.
  • Started any of the restricted medications.
  • Any vomiting, retching, or nausea (grade ≥ 1 as defined by National Cancer Institute) within 24 hours prior to the start of reference chemotherapy administration on Day 1.
  • Received or is scheduled to receive radiation therapy to the abdomen or the pelvis within 1 week prior to the start of the reference chemotherapy administration on Day 1 or between Days 1 to 5.
  • Symptomatic primary or metastatic CNS malignancy.

Trial locations and contacts

74 sites in 12 countries.

74 sites in 12 countries

Ukraine14 sites

  • Chernivtsi Regional Clinical Oncology Center, Day Care Unit

    Chernivtsi, 58013

  • Clinical Oncology Center, Department of Chemotherapy

    Dnipropetrovsk, 49055

  • Dnipropetrovsk City Multispecialty Clinical Hospital #4, Department of Chemotherapy

    Dnipropetrovsk, 49102

  • Regional Clinical Oncology Center, Chemotherapy Department

    Ivano-Frankivsk, 76000

  • S.P. Hryhoriev Institute of Medical Radiology, Department of Chemotherapy

    Kharkiv, 61024

  • Kharkiv Regional Clinical Oncology Center, Chemotherapy Department #1

    Kharkiv, 61070

  • Khmelnytskyi Regional Oncology Center, Surgery Department #1

    Khmelnytskyi, 29009

  • Kryvyi Rih Oncology Center, Department of Chemotherapy

    Kryvyi Rih, 50048

  • Lviv State Regional Treatment and Diagnostics Oncology Center, Department of Chemotherapy

    Lviv, 79031

  • Ternopil Regional Public Clinical Oncology Center

    Ternopil, 46023

  • LTD UNIMED Adjara

    Uzhhorod, 88000

  • Zakarpattia Regional Clinical Oncology Center, Department of Chemotherapy

    Uzhhorod, 88014

  • Vinnytsia Regional Clinical Oncology Center, Department of Chemotherapy

    Vinnytsia, 21029

  • Zaporizhia Regional Clinical Oncology Center, Thoracic Department

    Zaporizhia, 69040

Other trials in Ukraine

United States11 sites

  • Christus St. Frances Cabrini Hospital

    Alexandria, Louisiana, 71301

  • Indiana University Health Bloomington

    Bloomington, Indiana, 47403

  • Gabrail Cancer Center Research

    Canton, Ohio, 44718

  • North Shore Hematology Oncology Associates PC

    East Setauket, New York, 11733

  • West Cancer Center

    Germantown, Tennessee, 38138

  • St. Mary's Medical Center

    Grand Junction, Colorado, 81501

  • Provision Center for Biomedical Research

    Knoxville, Tennessee, 37909

  • Well Pharma Medical Research Corporation

    Miami, Florida, 33143

  • Illinois CancerCare

    Peoria, Illinois, 61615-7822

  • Sarcoma Oncology Center

    Santa Monica, California, 90403-480

  • The Oncology Institute of Hope and Innovation

    Whittier, California, 90603

Other trials in United States

Poland7 sites

  • Provincial Hospitals in Gdynia Sp. z o.o. (LLC)

    Gdynia

  • Lord's Transfiguration Teaching Hospital, Department of Chemotherapy

    Poznan, 60-569

  • Specialist Hospital in Prabuty Sp. z o .o. (LLC), Department of Pulmonology

    Prabuty, 82-550

  • Zofia Zamoyska nee Tarnowska Provincial Hospital in Tarnobrzeg

    Tarnobrzeg

  • Ludwik Rydygier Provincial Hospital

    Torun

  • Maria Sklodowska-Curie Institute of Oncology, Department of Lung and Thoracic Cancers

    Warsaw, 02-781

  • MAGODENT Sp. z o .o. (LLC), Branch No. 4, Department of Clinical Oncology/Chemotherapy

    Warsaw, 03-291

Other trials in Poland

Czechia6 sites

  • University Hospital Brno. Clinic of Pulmonary Diseases and Tuberculosis

    Brno

  • University Hospital

    Brno

  • Hospital Novy Jicin, Department of Oncology

    Nový Jičín

  • Thomayer's Hospital, Clinic of Pneumology

    Prague, 140 59

  • Hospital Na Bulovce

    Prague

  • Masaryk's Hospital Usti nad Labem, Oncology Dept

    Ústí nad Labem

Other trials in Czechia

Italy6 sites

  • S. G. Moscati Hospital, Medical Oncology Division

    Avellino

  • cientific Institute of Romagna for the Study and Treatment of Cancer (IRST), IRCCS

    Meldola

  • National Cancer Institute, IRCCS, Medical Oncology Department

    Milan

  • Azienda Socio Sanitaria Territoriale-Monza (ASST-Monza) - Oncology Department

    Monza

  • Regional Hospital "San Carlo"

    Potenza

  • Local Healthcare Company of Vimercate (ASST Vimercate)

    Vimercate

Other trials in Italy

Serbia6 sites

  • Clinical Center of Serbia, Clinic of Pulmonology

    Belgrade

  • Clinical Hospital Center Bezanijska Kosa, Clinic of Oncology

    Belgrade

  • Institute of Oncology and Radiology of Serbia, Clinic of Medical Oncology

    Belgrade

  • Military Medical Academy

    Belgrade

  • Institute of Pulmonary Diseases of Vojvodina, Pulmonary Oncology Clinic

    Kamenitz

  • Oncology Institute of Vojvodina

    Kamenitz

Other trials in Serbia

Austria5 sites

  • University Hospital Graz, Department of Internal Medicine

    Graz, 8036

  • Krems Country Hospital

    Krems

  • Hospital Elisabethinen Linz GmbH, Internal Department #1 - Hemato-Oncology

    Linz, 4020

  • General Hospital Linz GmbH, Internal Medicine Department #3 - Center for Hematology and Medical Oncology

    Linz, 4021

  • University Hospital St. Poelten,1st Medical Department

    Sankt Pölten

Other trials in Austria

Germany5 sites

  • Onkoligische Schwerpunktpraxis Bielefeld

    Bielefeld

  • OncoResearch Lerchenfeld GmbH

    Hamburg

  • Hannover Medical School

    Hanover

  • Universitaetsklinikum Leipzig; Universitaeres Krebszentrum (UCCL)

    Leipzig

  • Staedtisches Klinikum Muenchen GmbH; Klinikum N euperlach

    München

Other trials in Germany

Spain5 sites

  • Our Lady of Sonsoles Hospital

    Ávila, 05004

  • Hospital Puerta de Hierro

    Madrid, 28035

  • Hospital La Paz, Oncology Department

    Madrid

  • University Hospital Quiron Madrid, Department of Oncology

    Madrid

  • Hospital Nuestra Senora de Valme

    Seville, Andalusia

Other trials in Spain

Croatia4 sites

  • Clinical Hospital Centre Osijek

    Osijek

  • General Hospital Varazdin

    Varaždin

  • Clinical Hospital Center "Sestre milosrdnice"

    Zagreb

  • University Hospital Centre Zagreb "Jordanovac"

    Zagreb

Other trials in Croatia

Israel3 sites

  • Barziali Medical Center, Oncology Unit

    Ashkelon

  • Soroka University Medical Center,Oncology division

    Beersheba

  • Rambam Health Care Campus

    Haifa

Other trials in Israel

South Africa2 sites

  • GVI Outeniqua Oncology Unit

    George

  • Medical Oncology Centre of Rosebank

    Johannesburg

Other trials in South Africa

About this study

Official title: A Phase 3, Multicenter, Randomized, Double-blind, Active Control Study to Evaluate the Safety and Efficacy of IV Pro-netupitant/Palonosetron (260 mg/0.25 mg) Combination for the Prevention of Chemotherapy-induced Nausea and Vomiting in Repeated Chemotherapy Cycles in Patients Receiving Highly Emetogenic Chemotherapy

NEPA-15-18 is a clinical study assessing safety of pro-netupitant and palonosetron, two antiemetic drugs, given with oral dexamethasone. The objective of the study is to evaluate if pro-netupitant and palonosetron are safe when administered to prevent nausea and vomiting after administration of repeated cycles of chemotherapy.

Being tested
Pro-netupitant/Palonosetron, Netupitant/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.

  • Pro-netupitant/PalonosetronDrug

    Also called IV NEPA FDC

  • Netupitant/PalonosetronDrug

    Also called Oral NEPA FDC

  • DexamethasoneDrug

Study groups in NCT02517021
Study groupRoleWhat they receive
Pro-netupitant/Palonosetron plus DexamethasoneExperimentalIntravenous Pro-netupitant/Palonosetron (260 mg/0.25 mg) powder for solution for infusion (on Day 1) with oral dexamethasone prior to each scheduled chemotherapy cycle
Receives: Drug: Pro-netupitant/Palonosetron; Drug: Dexamethasone
Netupitant/Palonosetron plus DexamethasoneActive comparatorOral netupitant/palonosetron (300 mg/0.50 mg) hard capsule (on Day 1) with oral dexamethasone prior to each scheduled chemotherapy cycle
Receives: Drug: Netupitant/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 is a safety study where Adverse Events is the primary outcome (defined by the current ICH Guideline for Good Clinical Practice). Patients are randomized according to a 1:1 ratio (IV NEPA FDC : oral NEPA FDC). No formal comparison is planned, the presence of a control in the same patient population helps interpret any unexpected safety finding in the experimental arm. It is expected that the number of patients randomized to the test group, i.e., 200, will allow approximately 100 patients to be treated with the test drug for 4 cycles. Based on 100 patients treated at Cycle 4 with the IV NEPA FDC , if a given Adverse Event (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 14 weeks assuming a maximum of 4 chemotherapy cycles given every 3 weeks.

Secondary outcomes (9)

  1. Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication, in the Acute Phase

    Measured: 0-24 hours

  2. Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication, in the Delayed Phase

    Measured: >24-120 hours

  3. Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication, in the Overall Phase

    Measured: 0-120 hours

  4. Percentage of Patients With no Emetic Episodes in the Acute Phase

    Measured: 0-24 hours

  5. Percentage of Patients With no Emetic Episodes in the Delayed Phase

    Measured: >24-120 hours

  6. Percentage of Patients With no Emetic Episodes in the Overall Phase

    Measured: 0-120 hours

  7. Percentage of Patients With no Significant Nausea (VAS <25 mm) During the Acute Phase

    Measured: 0-24 hours

  8. Percentage of Patients With no Significant Nausea (VAS <25 mm) During the Delayed Phase

    Measured: >24-120 hours

  9. Percentage of Patients With no Significant Nausea (VAS <25 mm) During the Overall Phase

    Measured: 0-120 hours

Timeline

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

  1. First posted6 Aug 2015 (estimated)
  2. Study startNov 2015
  3. Primary completionAug 2016
  4. Study completionAug 2016

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
405 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02517021
Sponsor's protocol ID
NEPA-15-18
Status last verified
Jun 2018
First submitted
3 Aug 2015
Last updated
20 Jun 2018
Data monitoring committee
Yes

Publications

  • Schwartzberg L, Roeland E, Andric Z, Kowalski D, Radic J, Voisin D, Rizzi G, Navari R, Gralla RJ, Karthaus M. Phase III safety study of intravenous NEPA: a novel fixed antiemetic combination of fosnetupitant and palonosetron in patients receiving highly emetogenic chemotherapy. Ann Oncol. 2018 Jul 1;29(7):1535-1540. doi: 10.1093/annonc/mdy169.

    PubMed 29722791

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pro-netupitant/Palonosetron, Netupitant/Palonosetron and Dexamethasone in people with Chemotherapy-Induced Nausea and Vomiting, run by Helsinn Healthcare SA at 74 sites in 12 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 15 inclusion and 32 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 20 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 74 sites in Ukraine, United States, Poland, Czechia, Italy and 7 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 20 Jun 2018). 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 14 weeks assuming a maximum of 4 chemotherapy cycles given every 3 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 NCT02517021, which also lists 1 linked publication.

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 20 Jun 2018.

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