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

NCT ID: NCT01363479

Last Updated: 2021-09-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 743 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2012-11-30

Brief 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. 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.

Conditions

Chemotherapy-Induced Nausea and Vomiting

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Oral palonosetron

Intervention Type: DRUG

Dexamethasone

Intervention Type: DRUG

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.

Group Type: ACTIVE_COMPARATOR

I.V. palonosetron

Intervention Type: DRUG

Dexamethasone

Intervention Type: DRUG

Interventions

Oral palonosetron

Intervention Type: DRUG

I.V. palonosetron

Intervention Type: DRUG

Dexamethasone

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Parexel

INDUSTRY

Sponsor Role: collaborator

Helsinn Healthcare SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Genesis Cancer Centre

Hot Springs, Arkansas, United States

Compassionate Cancer Center

Corona, California, United States

Compassionate Cancer Centre Medical Group

Fountain Valley, California, United States

Facey Medical Group

Mission Hills, California, United States

Compassionate Cancer Care Medical Group

Riverside, California, United States

Signal Point Clinical Research Center, LLC

Middletown, Ohio, United States

Wellmont Medical Associates-Oncology and Hematology

Bristol, Rhode Island, United States

Charleston Hematology Oncology

Charleston, South Carolina, United States

Northern Utah Associates [Hematology/ Oncology]

Ogden, Utah, United States

Centro Oncológico Integral (COI)

Mar del Plata, Buenos Aires, Argentina

Clínica Universitaria Reina Fabiola

Córdoba, , Argentina

Instituto Oncológico de Córdoba (IONC)

Córdoba, , Argentina

Instituto Médico CER [Oncology]

Quilmes, , Argentina

Sanatorio Parque

Rosario, , Argentina

Centro Medico San Roque

San Miguel de Tucumán, , Argentina

ISIS Clinica Especializada

Santa Fe, , Argentina

MHAT Dr. Tota Venkova

Gabrovo, , Bulgaria

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

Sofia, , Bulgaria

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

Sofia, , Bulgaria

Specialised Hospital for Active treatment on Oncology

Sofia, , Bulgaria

District Dispensery for Oncology Diseases with in-patient

Sofia, , Bulgaria

Complex Oncology Centre

Stara Zagora, , Bulgaria

Klinicki bolnicki centar [Oncology]

Osijek, , Croatia

KBC Rijeka

Rijeka, , Croatia

Opca bolnica Varazdin

Varaždin, , Croatia

KBC Zagreb

Zagreb, , Croatia

Klinicka bolnica [Sestre milosrdnice]

Zagreb, , Croatia

Klinik und Poliklinik für Onkologie und Hämatologie Universitätsmedizin Charité Mitte

Berlin, , Germany

OncoResearch Lerchenfeld UG

Hamburg, , Germany

Städtisches Klinikum München

München, , Germany

Staedtisches Krankenhaus Muenchen Neuperlach

München, , Germany

Semmelweis Egyetem Kútvölgyi Klinikai Tömb

Budapest, , Hungary

Fővárosi Önkormányzat Uzsoki utcai Kórház

Budapest, , Hungary

Petz Aladár Megyei Oktató Kórház

Győr, , Hungary

Bács-Kiskun Megyei Önkormányzat Kórháza, Szeged

Kecskemét, , Hungary

Pécsi Tudományegyetem [Onkoterápiás Intézet]

Pécs, , Hungary

Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz

Szolnok, , Hungary

Yashoda Super speciality Hospital

Hyderabad, Andhra Pradesh, India

Sujan Surgical Cancer Hospital and Amracvati Cancer Foundation

Pune, Maharashtra, India

Apollo Speciality Hospital

Chennai, Tamil Nadu, India

Sri Venkateshwara Hospital [Medical Oncology]

Bangalore, , India

Chinmaya Mission Hospital

Bangalore, , India

City Cancer Centre [Surgical and Medical Oncology]

Vijayawada, , India

Fondazione Poliambulanza Istituto Ospedaliero

Brescia, , Italy

Ospedale Vito Fazzi - ASL Lecce

Lecce, , Italy

Presidio Ospedaliero "Alessandro Manzoni"

Lecco, , Italy

AO Regionale S.Carlo di Potenza

Potenza, , Italy

Szpital Wojewodzki Zespolony

Elblag, , Poland

Wojewodzki Szpital Specjalistyczny im. M.Kopernika

Lodz, , Poland

Wojewodzki Szpital Specjalistyczny im. J. Korczaka

Słupsk, , Poland

Centrum Onkologii - Instytut im. Marii Sklodowskiej - Curie

Warsaw, , Poland

NZOZ Magodent - Centrum Medczyne Ostrobramska

Warsaw, , Poland

Szpital Wojewodzki w Lomzy im. Kardynala S. Wyszynskiego

Łomża, , Poland

Spitalul Judetean de Urgenta "Dr. Constantin Opris"

Baia Mare, , Romania

Institutul Oncologic "Prof. Dr. Alex. Trestioreanu"

Bucharest, , Romania

Institutul Oncologic "Prof. Dr. Ion Chiricuta"

Cluj-Napoca, , Romania

Spitalul Clinic Judetean de Urgenta Cluj (Oncologie Medicala)

Cluj-Napoca, , Romania

Centrul de Oncologie Euroclinic

Iași, , Romania

Institutul Regional de Oncologie Iasi

Iași, , Romania

Spitalul Clinic Judetean de Urgenta Sibiu [Oncologie]

Sibiu, , Romania

Oncomed SRL

Timișoara, , Romania

GUZ Arkhangelsk Regional Clinical Oncological Dispensary

Arkhangelsk, , Russia

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

Krasnoyarsk, , Russia

GUZ Lipetsk Regional Oncology Dispensary [General Oncology]

Lipetsk, , Russia

GUZ Regional Oncology Dispensary #2

Magnitogorsk, , Russia

RAMN - Russian Cancer Research Center

Moscow, , Russia

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

Moscow, , Russia

MBUZ City Clinical Hospital #1 [Oncology]

Novosibirsk, , Russia

FGBU "Medical Radiology Scientific Center of Minzdravsotsrazvitiya RF

Obninsk, , Russia

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

Ryazan, , Russia

GUZ Leningrad Regional Oncological Dispensary

Saint Petersburg, , Russia

St. Petersburg Clinical Oncology Dispesary

Saint Petersburg, , Russia

Komunalnyi likuvalno-profilaktychnyi zaklad "Chernigivskyi

Chernihiv, , Ukraine

Komunalnyi zaklad Miska bahatoprofilna klinichna likarnia #4

Dnipropetrovsk, , Ukraine

Komunalno-klinichnyi likuvalno-profilaktychnyi zaklad

Donetsk, , Ukraine

DU IMR AMNU [vd khemter]

Kharkiv, , Ukraine

Kharkivskyi oblasnyi onkologichnyi klinichnyi tsentr

Kharkiv, , Ukraine

Chmelnytskyi Regional Clinical Oncology Centre [Oncology]

Khmelnytskyi, , Ukraine

Uzhgorod National University

Uzhhorod, , Ukraine

Countries

United States; Argentina; Bulgaria; Croatia; Germany; Hungary; India; Italy; Poland; Romania; Russia; Ukraine

Other Identifiers

PALO-10-01

Identifier Type: -

Identifier Source: org_study_id