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

Information source: Helsinn Healthcare SA
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chemotherapy-Induced Nausea and Vomiting

Intervention: Oral palonosetron (Drug); I.V. palonosetron (Drug); Dexamethasone (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Helsinn Healthcare SA


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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Primary outcome: Proportion of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication

Secondary outcome:

Proportion of Patients With no Emesis

Proportion of Patients With no Rescue Medication


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria:

- Naïve to cytotoxic chemotherapy. Previous biological or hormonal therapy is


- 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

Locations and Contacts

Instituto Oncológico de Córdoba (IONC), Cordoba X5006HBF, Argentina

Clínica Universitaria Reina Fabiola, Córdoba X5004FHP, Argentina

Instituto Médico CER [Oncology], Quilmes B1878DVB, Argentina

Sanatorio Parque, Rosario 2000, Argentina

Centro Medico San Roque, San Miguel de Tucuman T4000AIK, Argentina

ISIS Clinica Especializada, Santa Fe 3000, Argentina

MHAT Dr. Tota Venkova, Gabrovo 5300, Bulgaria

District Dispensery for Oncology Diseases with in-patient, Sofia 6300, Bulgaria

Specialised Hospital for Active treatment on Oncology, Sofia 1756, Bulgaria

Specialized Hospital for Active Treatement of Oncology Diseases - Sofia District Medical Oncology Department, Sofia 1233, Bulgaria

UMHAT "Tsaritsa Yoanna - ISUL" Ltd.Medical Oncology Clinic, Sofia 1572, Bulgaria

Complex Oncology Centre, Stara Zagora 6003, Bulgaria

Klinicki bolnicki centar [Oncology], Osijek 31000, Croatia

KBC Rijeka, Rijeka 51000, Croatia

Opca bolnica Varazdin, Varazdin 42000, Croatia

KBC Zagreb, Zagreb 10000, Croatia

Klinicka bolnica [Sestre milosrdnice], Zagreb 10000, Croatia

Klinik und Poliklinik für Onkologie und Hämatologie Universitätsmedizin Charité Mitte, Berlin 10117, Germany

OncoResearch Lerchenfeld UG, Hamburg 22081, Germany

Staedtisches Krankenhaus Muenchen Neuperlach, München 81737, Germany

Städtisches Klinikum München, München 81545, Germany

Fővárosi Önkormányzat Uzsoki utcai Kórház, Budapest 1145, Hungary

Semmelweis Egyetem Kútvölgyi Klinikai Tömb, Budapest 1125, Hungary

Petz Aladár Megyei Oktató Kórház, Györ 9024, Hungary

Bács-Kiskun Megyei Önkormányzat Kórháza, Szeged, Kecskemet 6000, Hungary

Pécsi Tudományegyetem [Onkoterápiás Intézet], Pécs 7624, Hungary

Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz, Szolnok 5004, Hungary

Chinmaya Mission Hospital, Bangalore 632004, India

Sri Venkateshwara Hospital [Medical Oncology], Bangalore 560068, India

Yashoda Super speciality Hospital, Hyderabad Andhra Pradesh 500 082, India

Sujan Surgical Cancer Hospital and Amracvati Cancer Foundation, Maharashtra 444605, India

Apollo Speciality Hospital, Tamil Nadu 600035, India

City Cancer Centre [Surgical and Medical Oncology], Vijayawada 520002, India

Fondazione Poliambulanza Istituto Ospedaliero, Brescia 25124, Italy

Ospedale Vito Fazzi - ASL Lecce, Lecce 73100, Italy

Presidio Ospedaliero "Alessandro Manzoni", Lecco 23900, Italy

AO Regionale S.Carlo di Potenza, Potenza 85100, Italy

Szpital Wojewodzki Zespolony, Elblag 82-300, Poland

Wojewodzki Szpital Specjalistyczny im. M.Kopernika, Lodz 93-509, Poland

Szpital Wojewodzki w Lomzy im. Kardynala S. Wyszynskiego, Lomza 18-400, Poland

Wojewodzki Szpital Specjalistyczny im. J. Korczaka, Slupsk 76-200, Poland

Centrum Onkologii - Instytut im. Marii Sklodowskiej - Curie, Warszawa 02-781, Poland

NZOZ Magodent - Centrum Medczyne Ostrobramska, Warszawa 04-125, Poland

Spitalul Judetean de Urgenta "Dr. Constantin Opris", Baia-Mare 430031, Romania

Institutul Oncologic "Prof. Dr. Alex. Trestioreanu", Bucharest 22328, Romania

Institutul Oncologic "Prof. Dr. Ion Chiricuta", Cluj-Napoca 400015, Romania

Spitalul Clinic Judetean de Urgenta Cluj (Oncologie Medicala), Cluj-Napoca 400349, Romania

Centrul de Oncologie Euroclinic, Iasi 700106, Romania

Institutul Regional de Oncologie Iasi, Iasi 700483, Romania

Spitalul Clinic Judetean de Urgenta Sibiu [Oncologie], Sibiu 550245, Romania

Oncomed SRL, Timisoara 300239, Romania

GUZ Arkhangelsk Regional Clinical Oncological Dispensary, Arkhangelsk 163045, Russian Federation

GOU VPO Krasnoyarsk State Medical University n.a. prof. V.F., Krasnoyarsk 660022, Russian Federation

GUZ Lipetsk Regional Oncology Dispensary [General Oncology], Lipetsk 398005, Russian Federation

GUZ Regional Oncology Dispensary #2, Magnitogorsk 455001, Russian Federation

RAMN - Russian Cancer Research Center, Moscow 115478, Russian Federation

Russian Oncology Research Center n.a. N.N. Blokhin RAMN, Moscow 115478, Russian Federation

MBUZ City Clinical Hospital #1 [Oncology], Novosibirsk 630047, Russian Federation

FGBU "Medical Radiology Scientific Center of Minzdravsotsrazvitiya RF, Obninsk 249036, Russian Federation

Ryazan State Med. Univer. n.a. I.I.Pavlov based Ryazan Regio, Ryazan 390026, Russian Federation

GUZ Leningrad Regional Oncological Dispensary, Saint Petersburg 188663, Russian Federation

St. Petersburg Clinical Oncology Dispesary, Saint Petersburg 197022, Russian Federation

Komunalnyi likuvalno-profilaktychnyi zaklad "Chernigivskyi, Chernigiv 14029, Ukraine

Komunalnyi zaklad Miska bahatoprofilna klinichna likarnia #4, Dnipropetrovsk 49102, Ukraine

Komunalno-klinichnyi likuvalno-profilaktychnyi zaklad, Donetsk 83092, Ukraine

DU IMR AMNU [vd khemter], Kharkiv 61024, Ukraine

Kharkivskyi oblasnyi onkologichnyi klinichnyi tsentr, Kharkiv 61070, Ukraine

Chmelnytskyi Regional Clinical Oncology Centre [Oncology], Khmelnytskyi 29009, Ukraine

Uzhgorod National University, Uzhgorod 88000, Ukraine

Genesis Cancer Centre, Hot Springs, Arkansas 71913, United States

Centro Oncológico Integral (COI), Mar del Plata, Buenos Aires 7600, Argentina

Compassionate Cancer Center, Corona, California 92879, United States

Compassionate Cancer Centre Medical Group, Fountain Valley, California 92708, United States

Facey Medical Group, Mission Hills, California 91345, United States

Compassionate Cancer Care Medical Group, Riverside, California 92501, United States

Signal Point Clinical Research Center, LLC, Middletown, Ohio 45042, United States

Wellmont Medical Associates-Oncology and Hematology, Bristol, Rhode Island 37620, United States

Charleston Hematology Oncology, Charleston, South Carolina 29414, United States

Northern Utah Associates [Hematology/ Oncology], Ogden, Utah 84403, United States

Additional Information

Starting date: July 2011
Last updated: November 6, 2014

Page last updated: August 23, 2015

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