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Chemotherapy-Induced Nausea and VomitingPhase 3NCT01363479

An Efficacy and Safety Study of Oral and Intravenous Palonosetron for the Prevention of Nausea and Vomiting

A Phase 3 study testing Oral palonosetron, I.V. palonosetron and Dexamethasone in people with Chemotherapy-Induced Nausea and Vomiting, run by Helsinn Healthcare SA at 79 sites in 12 countries.

Completed

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

Official record
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Trial summary

PALO-10-01 is a clinical study assessing efficacy and safety of a single oral dose of palonosetron compared to a single intravenous dose of palonosetron (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?
Oral palonosetron, I.V. palonosetron and Dexamethasone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
743 participants
Where
79 sitesin 12 countries
Study dates
Jul 2011to Nov 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

  • Naïve to cytotoxic chemotherapy. Previous biological or hormonal therapy is permitted.
  • Diagnosed with a malignant solid tumor and scheduled to receive first course of cytotoxic chemotherapy with cisplatin administered as a single I.V. dose of equal or more than 70 mg/m2 over 1-4 hours on study Day 1, either alone or in combination with other chemotherapeutic agents.
  • If scheduled to receive combination regimens, non-cisplatin agents of moderate to high emetogenic potential are allowed and they must be administered following the cisplatin infusion and completed no more than 6 hours after the initiation of cisplatin infusion.
  • If scheduled to receive chemotherapy agents of minimal to low emetogenic potential, they are to be given on Day 1 following cisplatin 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
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  • Hematologic and metabolic status adequate for receiving a highly emetogenic cisplatin-based regimen based on laboratory criteria (Neutrophils,Platelets, Bilirubin, Liver enzymes, Serum Creatinine or Creatinine Clearance)
  • If a patient has a known hepatic or renal impairment, he/she may be enrolled in this study at the discretion of the Investigator.
  • If a patient has a known history or predisposition to cardiac conduction interval abnormalities he/she may be enrolled in this study at the discretion of the Investigator.

Who cannot join

  • If female, pregnant or lactating.
  • Current use of illicit drugs or current evidence of alcohol abuse.
  • Scheduled to receive moderately emetogenic chemotherapy (MEC) or HEC from Day 2 to Day 5 following cisplatin administration.
  • Received or is scheduled to receive radiation therapy to the abdomen, or the pelvis within 1 week prior to Day 1 or between Days 1 to 5.
  • Any vomiting, retching, or mild nausea within 24 hours prior to Day 1.
  • Symptomatic primary or metastatic CNS malignancy.
Show all 13Show fewer
  • Active peptic ulcer disease, gastrointestinal obstruction, increased intracranial pressure, hypercalcemia, an active infection or any uncontrolled 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, CINV) or pose unwarranted risks in administering the study drugs to the patient.
  • Known hypersensitivity or contraindication to 5-HT3 receptor antagonists (e.g., palonosetron, ondansetron, granisetron, dolasetron, tropisetron, ramosetron) or dexamethasone.
  • Participation in a 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 study.
  • Systemic corticosteroid therapy at any dose within 72 hours prior to Day 1. However topical and inhaled corticosteroids with a steroid dose of £ 10 mg of prednisone daily or its equivalent 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 Day 1

Trial locations and contacts

79 sites in 12 countries.

79 sites in 12 countries

Russia11 sites

  • GUZ Arkhangelsk Regional Clinical Oncological Dispensary

    Arkhangelsk, 163045

  • GOU VPO Krasnoyarsk State Medical University n.a. prof. V.F.

    Krasnoyarsk, 660022

  • GUZ Lipetsk Regional Oncology Dispensary [General Oncology]

    Lipetsk, 398005

  • GUZ Regional Oncology Dispensary #2

    Magnitogorsk, 455001

  • RAMN - Russian Cancer Research Center

    Moscow, 115478

  • Russian Oncology Research Center n.a. N.N. Blokhin RAMN

    Moscow, 115478

  • MBUZ City Clinical Hospital #1 [Oncology]

    Novosibirsk, 630047

  • FGBU "Medical Radiology Scientific Center of Minzdravsotsrazvitiya RF

    Obninsk, 249036

  • Ryazan State Med. Univer. n.a. I.I.Pavlov based Ryazan Regio

    Ryazan, 390026

  • GUZ Leningrad Regional Oncological Dispensary

    Saint Petersburg, 188663

  • St. Petersburg Clinical Oncology Dispesary

    Saint Petersburg, 197022

Other trials in Russia

United States9 sites

  • Wellmont Medical Associates-Oncology and Hematology

    Bristol, Rhode Island, 37620

  • Charleston Hematology Oncology

    Charleston, South Carolina, 29414

  • Compassionate Cancer Center

    Corona, California, 92879

  • Compassionate Cancer Centre Medical Group

    Fountain Valley, California, 92708

  • Genesis Cancer Centre

    Hot Springs, Arkansas, 71913

  • Signal Point Clinical Research Center, LLC

    Middletown, Ohio, 45042

  • Facey Medical Group

    Mission Hills, California, 91345

  • Northern Utah Associates [Hematology/ Oncology]

    Ogden, Utah, 84403

  • Compassionate Cancer Care Medical Group

    Riverside, California, 92501

Other trials in United States

Romania8 sites

  • Spitalul Judetean de Urgenta "Dr. Constantin Opris"

    Baia Mare, 430031

  • Institutul Oncologic "Prof. Dr. Alex. Trestioreanu"

    Bucharest, 22328

  • Institutul Oncologic "Prof. Dr. Ion Chiricuta"

    Cluj-Napoca, 400015

  • Spitalul Clinic Judetean de Urgenta Cluj (Oncologie Medicala)

    Cluj-Napoca, 400349

  • Centrul de Oncologie Euroclinic

    Iași, 700106

  • Institutul Regional de Oncologie Iasi

    Iași, 700483

  • Spitalul Clinic Judetean de Urgenta Sibiu [Oncologie]

    Sibiu, 550245

  • Oncomed SRL

    Timișoara, 300239

Other trials in Romania

Argentina7 sites

  • Clínica Universitaria Reina Fabiola

    Córdoba, X5004FHP

  • Instituto Oncológico de Córdoba (IONC)

    Córdoba, X5006HBF

  • Centro Oncológico Integral (COI)

    Mar del Plata, Buenos Aires, 7600

  • Instituto Médico CER [Oncology]

    Quilmes, B1878DVB

  • Sanatorio Parque

    Rosario, 2000

  • Centro Medico San Roque

    San Miguel de Tucumán, T4000AIK

  • ISIS Clinica Especializada

    Santa Fe, 3000

Other trials in Argentina

Ukraine7 sites

  • Komunalnyi likuvalno-profilaktychnyi zaklad "Chernigivskyi

    Chernihiv, 14029

  • Komunalnyi zaklad Miska bahatoprofilna klinichna likarnia #4

    Dnipropetrovsk, 49102

  • Komunalno-klinichnyi likuvalno-profilaktychnyi zaklad

    Donetsk, 83092

  • DU IMR AMNU [vd khemter]

    Kharkiv, 61024

  • Kharkivskyi oblasnyi onkologichnyi klinichnyi tsentr

    Kharkiv, 61070

  • Chmelnytskyi Regional Clinical Oncology Centre [Oncology]

    Khmelnytskyi, 29009

  • Uzhgorod National University

    Uzhhorod, 88000

Other trials in Ukraine

Bulgaria6 sites

  • MHAT Dr. Tota Venkova

    Gabrovo, 5300

  • Specialized Hospital for Active Treatement of Oncology Diseases - Sofia District Medical Oncology Department

    Sofia, 1233

  • UMHAT "Tsaritsa Yoanna - ISUL" Ltd.Medical Oncology Clinic

    Sofia, 1572

  • Specialised Hospital for Active treatment on Oncology

    Sofia, 1756

  • District Dispensery for Oncology Diseases with in-patient

    Sofia, 6300

  • Complex Oncology Centre

    Stara Zagora, 6003

Other trials in Bulgaria

Hungary6 sites

  • Semmelweis Egyetem Kútvölgyi Klinikai Tömb

    Budapest, 1125

  • Fővárosi Önkormányzat Uzsoki utcai Kórház

    Budapest, 1145

  • Petz Aladár Megyei Oktató Kórház

    Győr, 9024

  • Bács-Kiskun Megyei Önkormányzat Kórháza, Szeged

    Kecskemét, 6000

  • Pécsi Tudományegyetem [Onkoterápiás Intézet]

    Pécs, 7624

  • Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz

    Szolnok, 5004

Other trials in Hungary

India6 sites

  • Sri Venkateshwara Hospital [Medical Oncology]

    Bangalore, 560068

  • Chinmaya Mission Hospital

    Bangalore, 632004

  • Apollo Speciality Hospital

    Chennai, Tamil Nadu, 600035

  • Yashoda Super speciality Hospital

    Hyderabad, Andhra Pradesh, 500 082

  • Sujan Surgical Cancer Hospital and Amracvati Cancer Foundation

    Pune, Maharashtra, 444605

  • City Cancer Centre [Surgical and Medical Oncology]

    Vijayawada, 520002

Other trials in India

Poland6 sites

  • Szpital Wojewodzki Zespolony

    Elblag, 82-300

  • Wojewodzki Szpital Specjalistyczny im. M.Kopernika

    Lodz, 93-509

  • Szpital Wojewodzki w Lomzy im. Kardynala S. Wyszynskiego

    Łomża, 18-400

  • Wojewodzki Szpital Specjalistyczny im. J. Korczaka

    Słupsk, 76-200

  • Centrum Onkologii - Instytut im. Marii Sklodowskiej - Curie

    Warsaw, 02-781

  • NZOZ Magodent - Centrum Medczyne Ostrobramska

    Warsaw, 04-125

Other trials in Poland

Croatia5 sites

  • Klinicki bolnicki centar [Oncology]

    Osijek, 31000

  • KBC Rijeka

    Rijeka, 51000

  • Opca bolnica Varazdin

    Varaždin, 42000

  • KBC Zagreb

    Zagreb, 10000

  • Klinicka bolnica [Sestre milosrdnice]

    Zagreb, 10000

Other trials in Croatia

Germany4 sites

  • Klinik und Poliklinik für Onkologie und Hämatologie Universitätsmedizin Charité Mitte

    Berlin, 10117

  • OncoResearch Lerchenfeld UG

    Hamburg, 22081

  • Städtisches Klinikum München

    München, 81545

  • Staedtisches Krankenhaus Muenchen Neuperlach

    München, 81737

Other trials in Germany

Italy4 sites

  • Fondazione Poliambulanza Istituto Ospedaliero

    Brescia, 25124

  • Ospedale Vito Fazzi - ASL Lecce

    Lecce, 73100

  • Presidio Ospedaliero "Alessandro Manzoni"

    Lecco, 23900

  • AO Regionale S.Carlo di Potenza

    Potenza, 85100

Other trials in Italy

About this study

Official title: Single-dose, Multicenter, Randomized, Double-blind, Double-dummy, Parallel Group Study to Assess the Efficacy and Safety of Oral Palonosetron 0.50 mg Compared to I.V. Palonosetron 0.25 mg Administered With Dexamethasone for the Prevention of Chemotherapy-induced Nausea and Vomiting in Cancer Patients Receiving Highly Emetogenic Cisplatin-based Chemotherapy

PALO-10-01 is a clinical study assessing efficacy and safety of a single oral dose of palonosetron compared to a single intravenous dose of palonosetron (Aloxi, an antiemetic drug), both given with oral dexamethasone. The objective of the study is to demonstrate that oral palonosetron 0.50 mg is as effective as (non-inferior to) 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
Oral palonosetron, I.V. 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 NCT01363479
Study groupRoleWhat they receive
Oral palonosteron plus dexamethasoneExperimentalOral palonosetron (Aloxi 0.50 mg softgel capsule) with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4.
Receives: Drug: Oral palonosetron; Drug: Dexamethasone
I.V. palonosetron plus dexamethasoneActive comparatorIntravenous palonosetron (Aloxi 0.25 mg solution for injection) with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4.
Receives: Drug: I.V. 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

    Measured: 0-24 hours

Secondary outcomes (2)

  1. Percentage of Patients With no Emesis

    Measured: 0-24 hours

  2. Percentage of Patients With no Rescue Medication

    Measured: 0-24 hours

Timeline

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

  1. First posted1 Jun 2011 (estimated)
  2. Study startJul 2011
  3. Primary completionNov 2012
  4. Study completionNov 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
743 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01363479
Sponsor's protocol ID
PALO-10-01
Status last verified
Aug 2021
First submitted
30 May 2011
Last updated
22 Sep 2021
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Oral palonosetron, I.V. palonosetron and Dexamethasone in people with Chemotherapy-Induced Nausea and Vomiting, run by Helsinn Healthcare SA at 79 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 9 inclusion and 13 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 22 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 79 sites in Russia, United States, Romania, Argentina, Ukraine 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 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 Complete Response (CR) Defined as no Emesis, no Rescue Medication (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 NCT01363479.

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 22 Sep 2021.

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