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Chemotherapy-Induced Nausea and VomitingPhase 3NCT02557035

An Efficacy and Safety Study of Intravenous Palonosetron Administered as an Infusion and as a Bolus for the Prevention of Nausea and Vomiting

A Phase 3 study testing Palonosetron and Dexamethasone in people with Chemotherapy-Induced Nausea and Vomiting, run by Helsinn Healthcare SA at 76 sites in 9 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

PALO-15-17 is a clinical study assessing efficacy and safety of a single dose of palonosetron 0.25 mg administered as a 30-minute IV infusion compared to palonosetron 0.25 mg administered as a 30-second IV bolus (Aloxi, an antiemetic drug), both given with oral dexamethasone. 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?
Palonosetron and Dexamethasone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
441 participants
Where
76 sitesin 9 countries
Study dates
Oct 2015to Mar 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

  • 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 first course of one of the following reference 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
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  • carmustine (BCNU) >250 mg/m2
  • dacarbazine (DTIC)
  • mechloretamine (nitrogen mustard)
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2 .
  • 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.

Who cannot join

  • Lactating woman.
  • Current use of illicit drugs or current evidence of alcohol abuse.
  • Scheduled to receive moderately emetogenic chemotherapy or highly emetogenic chemotherapy 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 HEC administration on Day 1 or between Days 1 to 5.
  • Any vomiting, retching, or nausea (grade ≥ 1 as defined by National Cancer Institute) within 24 hours prior to the start of the reference HEC administration on Day 1.
  • Symptomatic primary or metastatic CNS malignancy.
Show all 15Show fewer
  • Active peptic ulcer disease, gastrointestinal obstruction, increased intracranial pressure, hypercalcemia, an active infection or any illness or medical conditions (other than malignancy) that, in the opinion of the Investigator, may confound the results of the study, represent another potential etiology for emesis and nausea (other than chemotherapy-induced nausea and vomiting) or pose unwarranted risks in administering the study drugs to the patient.
  • Known hypersensitivity or contraindication to 5-HT3 receptor antagonists
  • Known contraindication to the IV administration of 50 mL 5% glucose solution.
  • Participation in a previous clinical trial involving 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 the reference HEC administration on Day 1. However, topical and inhaled corticosteroids are permitted.
  • Scheduled to receive bone marrow transplantation and/or stem cell rescue therapy.
  • Any medication with known or potential antiemetic activity within 24 hours prior to the start of the reference HEC administration on Day 1, including but not limited to 5-HT3 receptor antagonists and NK-1 receptor antagonists
  • Concurrent medical condition that would preclude administration of dexamethasone for 4 days such as systemic fungal infection or uncontrolled diabetes.

Trial locations and contacts

76 sites in 9 countries.

76 sites in 9 countries

Russia34 sites

  • Arkhangelsk Clinical Oncology Center

    Arkhangelsk

  • Altay Territorial Oncology Center

    Barnaul

  • Bryansk Regional Oncology Center

    Bryansk

  • Chelyabinsk Regional Clinical Oncology Center

    Chelyabinsk

  • Evimed, LLC

    Chelyabinsk

  • Ivanovo Regional Oncology Center

    Ivanovo

  • Kaluga Regional Oncology Center

    Kaluga

  • Republican Clinical Oncology Center

    Kazan'

  • Krasnoyarsk A.I. Kryzhanovsky Regional Oncology Center

    Krasnoyarsk

  • Moscow City Oncology Hospital #62

    Moscow

  • Moscow Clinical Scientific and Practical Center

    Moscow

  • N.N. Blokhin Russian Oncology Research Center, Surgery Dept. 2

    Moscow

  • N.N. Blokhin Russian Oncology Research Center, Surgery Dept. of Female Reproductive System Tumors

    Moscow

  • N.N. Blokhin Russian Oncology Research Center

    Moscow

  • Branch #1 of Nizhny Novgorod Regional Oncology Center

    Nizhny Novgorod

  • City Clinical Hospital #1

    Novosibirsk

  • Novosibirsk Regional Oncology Center

    Novosibirsk

  • Clinical Oncology Center, Dept. of Chemotherapy

    Omsk

  • Clinical Oncology Center

    Omsk

  • Orenburg Regional Clinical Oncology Center

    Orenburg

  • Pyatigorsk Oncology Center

    Pyatigorsk

  • Regional Clinical Oncology Center

    Ryazan

  • City Clinical Oncology Center, Thoracic Oncology Dept.

    Saint Petersburg

  • City Clinical Oncology Center, Urology Oncology Dept.

    Saint Petersburg

  • City Clinical Oncology Center

    Saint Petersburg

  • First I.P. Pavlov State Medical University of St. Petersburg

    Saint Petersburg

  • St.Petersburg Municipal Clinical Oncology Center

    Saint Petersburg

  • Samara Regional Clinical Oncology Center

    Samara

  • Tambov Regional Oncology Center

    Tambov

  • Tomsk Research Institute of Oncology, General Oncology Dept.

    Tomsk

  • Tomsk Research Institute of Oncology

    Tomsk

  • Republican Clinical Oncology Center

    Ufa

  • Regional Clinical Oncology Center

    Velikiy Novgorod

  • Sverdlovsk Regional Oncology Center

    Yekaterinburg

Other trials in Russia

Romania12 sites

  • Oncopremium Team SRL, Department of Oncology

    Baia Mare

  • Prof. Dr. Alexandru Trestioreanu Institute of Oncology, Medical Oncology Department II

    Bucharest, 022328

  • Coltea Clinical Hospital, Department of Medical Oncology

    Bucharest, 030171

  • Hifu Terramed Conformal SRL, Department of Medical Oncology

    Bucharest, 031864

  • Ianuli Med Consult SRL, Oncology Department

    Bucharest

  • "Prof. Dr. Ion Chiricuta" Institute of Oncology, Radiotherapy Department I

    Cluj-Napoca, 400015

  • Radiotherapy Center Cluj SRL, Department of Oncology

    Cluj-Napoca

  • Constanta Emergency Clinical County Hospital, Department of Medical Oncology

    Constanța, 900591

  • Oncology Center "Sf. Nectarie", Department of Medical Oncology

    Craiova

  • Suceava Sf. Ioan cel Nou Emergency County Hospital, Department of Medical Oncology

    Suceava, 720237

  • Oncomed SRL, Department of Medical Oncology

    Timișoara, 300239

  • Oncocenter Clinical Oncology SRL, Department of Medical Oncology

    Timișoara

Other trials in Romania

Bulgaria9 sites

  • Multiprofile Hospital for Active Treatment, Dobrich, Department of Medical Oncology

    Dobrich, 9300

  • Specialized Hospital for Active Treatment in Oncology, Haskovo, Department of Medical Oncology

    Haskovo, 6300

  • Multiprofile Hospital for Active Treatment "Central Onco Hospital", Plovdiv, Department of Medical Oncology

    Plovdiv, 4002

  • Complex Oncology Center, Ruse, Department of Medical Oncology

    Rousse, 7002

  • Multiprofile Hospital for Active Treatment "Serdika", Sofia, Department of Medical Oncology

    Sofia, 1303

  • University Multiprofile Hospital for Active Treatment "Sveti Ivan Rilski", Sofia, Department of Medical Oncology

    Sofia, 1431

  • Multiprofile Hospital for Active Treatment for Wonen's Health "Nadezhda"

    Sofia

  • Hospital for Active Treatment of Oncological Diseases "Dr. Marko Antonov Markov", Varna, Department of Medicinal Oncology and Palliative Care

    Varna, 9010

  • Multiprofile Hospital for Active Treatment "Sveta Marina", Varna, Clinic of Medical Oncology

    Varna, 9010

Other trials in Bulgaria

Hungary8 sites

  • Koranyi National Institute of TBC and Pulmonology

    Budapest, 1121

  • Uzsoki Hospital, Department of Radiation Oncology

    Budapest, 1145

  • University of Debrecen, Medical and Health Science Center

    Debrecen

  • Petz Aladar County Teaching Hospital, Center for Oncoradiology

    Győr, 9024

  • Kaposi Mor Teaching Hospital, Centre for Clinical Oncology

    Kaposvár, 7400

  • Borsod-Abauj-Zemplen County Hospital and University Educational Hospital

    Miskolc, 3526

  • Szabolcs-Szatmar-Bereg County Hospitals and University Teaching Hospital

    Nyíregyháza

  • Medical Center of the University of Pecs

    Pécs

Other trials in Hungary

Georgia4 sites

  • JSC NeoMedi

    Tbilisi, 0131

  • LTD Institute of Clinical Oncology

    Tbilisi, 0159

  • LTD Aversi Clinic

    Tbilisi, 0160

  • LDT High Technology Medical Center University Clinic

    Tbilisi

Other trials in Georgia

Greece4 sites

  • "Sotiria" Chest Diseases Hospital of Athens

    Athens

  • Thermi Clinic S.A.

    Thessaloniki, 570 01

  • General Hospital of Thessaloniki "G. Papanikolaou", University Department of Pulmonology

    Thessaloniki, 570 10

  • Bioclinic Thessalonikis S.A.

    Thessaloniki

Other trials in Greece

Belarus2 sites

  • N.N. Aleksandrov Republican Research Oncology and Medical Radiology Center, Department of Chemotherapy

    Lesnoy, 223052

  • Minsk City Clinical Oncology Center

    Minsk, 220013

Other trials in Belarus

Lithuania2 sites

  • Hospital of Lithuanian University of Health Sciences Kaunas Clinics, Oncology Hospital, Department of Conservative Oncology

    Kaunas, 45434

  • Hospital of Lithuanian University of Health Sciences Kaunas Clinics, Clinic of Oncology and Hematology

    Kaunas, 50009

Other trials in Lithuania

Bosnia and Herzegovina1 site

  • University Clinical Centre of the Republic of Srpska

    Banja Luka

Other trials in Bosnia and Herzegovina

About this study

Official title: A Phase 3, Single-dose, Multicenter, Randomized, Double-blind, Parallel Group Study to Assess the Efficacy and Safety of Palonosetron 0.25 mg Administered as a 30-minute IV Infusion Compared to Palonosetron 0.25 mg Administered as a 30-second IV Bolus for the Prevention of Chemotherapy-induced Nausea and Vomiting in Cancer Patients Receiving Highly Emetogenic Chemotherapy.

PALO-15-17 is a clinical study assessing efficacy and safety of a single dose of palonosetron 0.25 mg administered as a 30-minute IV infusion compared to palonosetron 0.25 mg administered as a 30-second IV bolus (Aloxi, an antiemetic drug), both given with oral dexamethasone. The objective of the study is to demonstrate that infused IV palonosetron 0.25 mg is as effective as (non-inferior to) injected palonosetron IV 0.25 mg to prevent nausea and vomiting induced by highly emetogenic cancer chemotherapy in the 0-24 hours after administration of a single cycle of highly emetogenic chemotherapy

Being tested
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.

Study groups in NCT02557035
Study groupRoleWhat they receive
I.V. palonosetron infusion plus dexamethasoneExperimentalIntravenous palonosetron (Aloxi 0.25 mg solution for injection) as an infusion with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4.
Receives: Drug: Palonosetron; Drug: Dexamethasone
I.V. palonosetron bolus plus dexamethasoneActive comparatorIntravenous palonosetron (Aloxi 0.25 mg solution for injection) as a bolus with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4.
Receives: 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 Complete Response (CR) Defined as no Emesis, no Rescue Medication, in the Acute Phase

    Measured: 0-24 hours

Secondary outcomes (8)

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

    Measured: >24-120 hours

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

    Measured: 0-120 hours

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

    Measured: 0-24 hours

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

    Measured: >24-120 hours

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

    Measured: 0-120 hours

  6. Percentage of Patients With no Rescue Medication in the Acute Phase

    Measured: 0-24 hours

  7. Percentage of Patients With no Rescue Medication in the Delayed Phase

    Measured: >24-120 hours

  8. Percentage of Patients With no Rescue Medication in 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 posted22 Sep 2015 (estimated)
  2. Study startOct 2015
  3. Primary completionMar 2016
  4. Study completionMar 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
441 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02557035
Sponsor's protocol ID
PALO-15-17
Status last verified
Jun 2018
First submitted
21 Sep 2015
Last updated
20 Jun 2018
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Palonosetron and Dexamethasone in people with Chemotherapy-Induced Nausea and Vomiting, run by Helsinn Healthcare SA at 76 sites in 9 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 13 inclusion and 15 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 76 sites in Russia, Romania, Bulgaria, Hungary, Georgia and 4 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 Complete Response (CR) Defined as no Emesis, no Rescue Medication, in the Acute Phase (time frame: 0-24 hours). 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 NCT02557035.

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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