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

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.

Study Overview

• Status: Completed
• Conditions: Chemotherapy-Induced Nausea and Vomiting
• Intervention / Treatment: Drug: Dexamethasone; Drug: Oral palonosetron; Drug: I.V. palonosetron

• Study Type: Interventional
• Enrollment (Actual): 743
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Cordoba, Argentina, X5006HBF
    • Instituto Oncologico de Cordoba (IONC)
  • Córdoba, Argentina, X5004FHP
    • Clinica Universitaria Reina Fabiola
  • Quilmes, Argentina, B1878DVB
    • Instituto Médico CER [Oncology]
  • Rosario, Argentina, 2000
    • Sanatorio Parque
  • San Miguel de Tucuman, Argentina, T4000AIK
    • Centro Medico San Roque
  • Santa Fe, Argentina, 3000
    • ISIS Clinica Especializada
  • Buenos Aires
    • Mar del Plata, Buenos Aires, Argentina, 7600
      • Centro Oncológico Integral (COI)
• Bulgaria
  • Gabrovo, Bulgaria, 5300
    • MHAT Dr. Tota Venkova
  • Sofia, Bulgaria, 1233
    • Specialized Hospital for Active Treatement of Oncology Diseases - Sofia District Medical Oncology Department
  • Sofia, Bulgaria, 1572
    • UMHAT "Tsaritsa Yoanna - ISUL" Ltd.Medical Oncology Clinic
  • Sofia, Bulgaria, 1756
    • Specialised Hospital for Active treatment on Oncology
  • Sofia, Bulgaria, 6300
    • District Dispensery for Oncology Diseases with in-patient
  • Stara Zagora, Bulgaria, 6003
    • Complex Oncology Centre
• Croatia
  • Osijek, Croatia, 31000
    • Klinicki bolnicki centar [Oncology]
  • Rijeka, Croatia, 51000
    • KBC Rijeka
  • Varazdin, Croatia, 42000
    • Opca bolnica Varazdin
  • Zagreb, Croatia, 10000
    • KBC Zagreb
  • Zagreb, Croatia, 10000
    • Klinicka bolnica [Sestre milosrdnice]
• Germany
  • Berlin, Germany, 10117
    • Klinik und Poliklinik für Onkologie und Hämatologie Universitatsmedizin Charite Mitte
  • Hamburg, Germany, 22081
    • OncoResearch Lerchenfeld UG
  • München, Germany, 81545
    • Städtisches Klinikum München
  • München, Germany, 81737
    • Staedtisches Krankenhaus Muenchen Neuperlach
• Hungary
  • Budapest, Hungary, 1125
    • Semmelweis Egyetem Kútvölgyi Klinikai Tömb
  • Budapest, Hungary, 1145
    • Fövárosi Önkormányzat uzsoki utcai Kórház
  • Györ, Hungary, 9024
    • Petz Aladar Megyei Oktato Korhaz
  • Kecskemet, Hungary, 6000
    • Bács-Kiskun Megyei Önkormányzat Kórháza, Szeged
  • Pécs, Hungary, 7624
    • Pécsi Tudományegyetem [Onkoterápiás Intézet]
  • Szolnok, Hungary, 5004
    • Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz
• India
  • Bangalore, India, 560068
    • Sri Venkateshwara Hospital [Medical Oncology]
  • Bangalore, India, 632004
    • Chinmaya Mission Hospital
  • Vijayawada, India, 520002
    • City Cancer Centre [Surgical and Medical Oncology]
  • Andhra Pradesh
    • Hyderabad, Andhra Pradesh, India, 500 082
      • Yashoda Super Speciality Hospital
  • Maharashtra
    • Pune, Maharashtra, India, 444605
      • Sujan Surgical Cancer Hospital and Amracvati Cancer Foundation
  • Tamil Nadu
    • Chennai, Tamil Nadu, India, 600035
      • Apollo Speciality Hospital
• Italy
  • Brescia, Italy, 25124
    • Fondazione Poliambulanza Istituto Ospedaliero
  • Lecce, Italy, 73100
    • Ospedale Vito Fazzi - ASL Lecce
  • Lecco, Italy, 23900
    • Presidio Ospedaliero "Alessandro Manzoni"
  • Potenza, Italy, 85100
    • AO Regionale S.Carlo di Potenza
• Poland
  • Elblag, Poland, 82-300
    • Szpital Wojewodzki Zespolony
  • Lodz, Poland, 93-509
    • Wojewodzki Szpital Specjalistyczny im. M.Kopernika
  • Lomza, Poland, 18-400
    • Szpital Wojewodzki w Lomzy im. Kardynala S. Wyszynskiego
  • Slupsk, Poland, 76-200
    • Wojewodzki Szpital Specjalistyczny im. J. Korczaka
  • Warszawa, Poland, 02-781
    • Centrum Onkologii - Instytut Im. Marii Sklodowskiej - Curie
  • Warszawa, Poland, 04-125
    • NZOZ Magodent - Centrum Medczyne Ostrobramska
• Romania
  • Baia-Mare, Romania, 430031
    • Spitalul Judetean de Urgenta "Dr. Constantin Opris"
  • Bucharest, Romania, 22328
    • Institutul Oncologic "Prof. Dr. Alex. Trestioreanu"
  • Cluj-Napoca, Romania, 400015
    • Institutul Oncologic "Prof. Dr. Ion Chiricuta"
  • Cluj-Napoca, Romania, 400349
    • Spitalul Clinic Judetean de Urgenta Cluj (Oncologie Medicala)
  • Iasi, Romania, 700106
    • Centrul de Oncologie Euroclinic
  • Iasi, Romania, 700483
    • Institutul Regional De Oncologie Iasi
  • Sibiu, Romania, 550245
    • Spitalul Clinic Judetean de Urgenta Sibiu [Oncologie]
  • Timisoara, Romania, 300239
    • Oncomed Srl
• Russian Federation
  • Arkhangelsk, Russian Federation, 163045
    • GUZ Arkhangelsk Regional Clinical Oncological Dispensary
  • Krasnoyarsk, Russian Federation, 660022
    • GOU VPO Krasnoyarsk State Medical University n.a. prof. V.F.
  • Lipetsk, Russian Federation, 398005
    • GUZ Lipetsk Regional Oncology Dispensary [General Oncology]
  • Magnitogorsk, Russian Federation, 455001
    • GUZ Regional Oncology Dispensary #2
  • Moscow, Russian Federation, 115478
    • RAMN - Russian Cancer Research Center
  • Moscow, Russian Federation, 115478
    • Russian Oncology Research Center n.a. N.N. Blokhin RAMN
  • Novosibirsk, Russian Federation, 630047
    • MBUZ City Clinical Hospital #1 [Oncology]
  • Obninsk, Russian Federation, 249036
    • FGBU "Medical Radiology Scientific Center of Minzdravsotsrazvitiya RF
  • Ryazan, Russian Federation, 390026
    • Ryazan State Med. Univer. n.a. I.I.Pavlov based Ryazan Regio
  • Saint Petersburg, Russian Federation, 188663
    • GUZ Leningrad Regional Oncological Dispensary
  • Saint Petersburg, Russian Federation, 197022
    • St. Petersburg Clinical Oncology Dispesary
• Ukraine
  • Chernihiv, Ukraine, 14029
    • Komunalnyi likuvalno-profilaktychnyi zaklad "Chernigivskyi
  • Dnipropetrovsk, Ukraine, 49102
    • Komunalnyi zaklad Miska bahatoprofilna klinichna likarnia #4
  • Donetsk, Ukraine, 83092
    • Komunalno-klinichnyi likuvalno-profilaktychnyi zaklad
  • Kharkiv, Ukraine, 61024
    • DU IMR AMNU [vd khemter]
  • Kharkiv, Ukraine, 61070
    • Kharkivskyi oblasnyi onkologichnyi klinichnyi tsentr
  • Khmelnytskyi, Ukraine, 29009
    • Chmelnytskyi Regional Clinical Oncology Centre [Oncology]
  • Uzhgorod, Ukraine, 88000
    • Uzhgorod National University
• United States
  • Arkansas
    • Hot Springs, Arkansas, United States, 71913
      • Genesis Cancer Centre
  • California
    • Corona, California, United States, 92879
      • Compassionate Cancer Center
    • Fountain Valley, California, United States, 92708
      • Compassionate Cancer Centre Medical Group
    • Mission Hills, California, United States, 91345
      • Facey Medical Group
    • Riverside, California, United States, 92501
      • Compassionate Cancer Care Medical Group
  • Ohio
    • Middletown, Ohio, United States, 45042
      • Signal Point Clinical Research Center, LLC
  • Rhode Island
    • Bristol, Rhode Island, United States, 37620
      • Wellmont Medical Associates-Oncology and Hematology
  • South Carolina
    • Charleston, South Carolina, United States, 29414
      • Charleston Hematology Oncology
  • Utah
    • Ogden, Utah, United States, 84403
      • Northern Utah Associates [Hematology/ Oncology]

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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
• 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.

Exclusion Criteria:

• 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.
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oral palonosteron plus dexamethasone; Oral 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.	Drug: Dexamethasone; Drug: Oral palonosetron
Active Comparator: I.V. palonosetron plus dexamethasone; Intravenous 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.	Drug: Dexamethasone; Drug: I.V. palonosetron

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication	0-24 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage of Patients With no Emesis	0-24 hours
Percentage of Patients With no Rescue Medication	0-24 hours

Collaborators and Investigators

• Sponsor: Helsinn Healthcare SA
• Collaborators: Parexel

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): November 1, 2012

Study Registration Dates

• First Submitted: May 30, 2011
• First Submitted That Met QC Criteria: May 31, 2011
• First Posted (Estimate): June 1, 2011

Study Record Updates

• Last Update Posted (Actual): September 22, 2021
• Last Update Submitted That Met QC Criteria: August 30, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Nausea; Vomiting; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Serotonin Agents; Serotonin Antagonists; Serotonin 5-HT3 Receptor Antagonists; Dexamethasone; Palonosetron
• Other Study ID Numbers: PALO-10-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No