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

Chemotherapy-Induced Nausea and Vomiting Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01363479
• Other study ID #: PALO-10-01
• Status: Completed
• Phase: Phase 3
• Start date: July 2011
• Est. completion date: November 2012

Study information

• Verified date: August 2021
• Source: Helsinn Healthcare SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 743
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chemotherapy-Induced Nausea and Vomiting
• Nausea
• Vomiting

Intervention

Drug:
• Oral palonosetron

• I.V. palonosetron

• Dexamethasone

Locations

Country	Name	City	State
Argentina	Instituto Oncológico de Córdoba (IONC)	Cordoba
Argentina	Clínica Universitaria Reina Fabiola	Córdoba
Argentina	Centro Oncológico Integral (COI)	Mar del Plata	Buenos Aires
Argentina	Instituto Médico CER [Oncology]	Quilmes
Argentina	Sanatorio Parque	Rosario
Argentina	Centro Medico San Roque	San Miguel de Tucuman
Argentina	ISIS Clinica Especializada	Santa Fe
Bulgaria	MHAT Dr. Tota Venkova	Gabrovo
Bulgaria	District Dispensery for Oncology Diseases with in-patient	Sofia
Bulgaria	Specialised Hospital for Active treatment on Oncology	Sofia
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	Complex Oncology Centre	Stara Zagora
Croatia	Klinicki bolnicki centar [Oncology]	Osijek
Croatia	KBC Rijeka	Rijeka
Croatia	Opca bolnica Varazdin	Varazdin
Croatia	KBC Zagreb	Zagreb
Croatia	Klinicka bolnica [Sestre milosrdnice]	Zagreb
Germany	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
Hungary	Fovárosi Önkormányzat Uzsoki utcai Kórház	Budapest
Hungary	Semmelweis Egyetem Kútvölgyi Klinikai Tömb	Budapest
Hungary	Petz Aladár Megyei Oktató Kórház	Györ
Hungary	Bács-Kiskun Megyei Önkormányzat Kórháza, Szeged	Kecskemet
Hungary	Pécsi Tudományegyetem [Onkoterápiás Intézet]	Pécs
Hungary	Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz	Szolnok
India	Chinmaya Mission Hospital	Bangalore
India	Sri Venkateshwara Hospital [Medical Oncology]	Bangalore
India	Apollo Speciality Hospital	Chennai	Tamil Nadu
India	Yashoda Super speciality Hospital	Hyderabad	Andhra Pradesh
India	Sujan Surgical Cancer Hospital and Amracvati Cancer Foundation	Pune	Maharashtra
India	City Cancer Centre [Surgical and Medical Oncology]	Vijayawada
Italy	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
Poland	Szpital Wojewodzki Zespolony	Elblag
Poland	Wojewodzki Szpital Specjalistyczny im. M.Kopernika	Lodz
Poland	Szpital Wojewodzki w Lomzy im. Kardynala S. Wyszynskiego	Lomza
Poland	Wojewodzki Szpital Specjalistyczny im. J. Korczaka	Slupsk
Poland	Centrum Onkologii - Instytut im. Marii Sklodowskiej - Curie	Warszawa
Poland	NZOZ Magodent - Centrum Medczyne Ostrobramska	Warszawa
Romania	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	Iasi
Romania	Institutul Regional de Oncologie Iasi	Iasi
Romania	Spitalul Clinic Judetean de Urgenta Sibiu [Oncologie]	Sibiu
Romania	Oncomed SRL	Timisoara
Russian Federation	GUZ Arkhangelsk Regional Clinical Oncological Dispensary	Arkhangelsk
Russian Federation	GOU VPO Krasnoyarsk State Medical University n.a. prof. V.F.	Krasnoyarsk
Russian Federation	GUZ Lipetsk Regional Oncology Dispensary [General Oncology]	Lipetsk
Russian Federation	GUZ Regional Oncology Dispensary #2	Magnitogorsk
Russian Federation	RAMN - Russian Cancer Research Center	Moscow
Russian Federation	Russian Oncology Research Center n.a. N.N. Blokhin RAMN	Moscow
Russian Federation	MBUZ City Clinical Hospital #1 [Oncology]	Novosibirsk
Russian Federation	FGBU "Medical Radiology Scientific Center of Minzdravsotsrazvitiya RF	Obninsk
Russian Federation	Ryazan State Med. Univer. n.a. I.I.Pavlov based Ryazan Regio	Ryazan
Russian Federation	GUZ Leningrad Regional Oncological Dispensary	Saint Petersburg
Russian Federation	St. Petersburg Clinical Oncology Dispesary	Saint Petersburg
Ukraine	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	Uzhgorod
United States	Wellmont Medical Associates-Oncology and Hematology	Bristol	Rhode Island
United States	Charleston Hematology Oncology	Charleston	South Carolina
United States	Compassionate Cancer Center	Corona	California
United States	Compassionate Cancer Centre Medical Group	Fountain Valley	California
United States	Genesis Cancer Centre	Hot Springs	Arkansas
United States	Signal Point Clinical Research Center, LLC	Middletown	Ohio
United States	Facey Medical Group	Mission Hills	California
United States	Northern Utah Associates [Hematology/ Oncology]	Ogden	Utah
United States	Compassionate Cancer Care Medical Group	Riverside	California

Sponsors (2)

Lead Sponsor	Collaborator
Helsinn Healthcare SA	Parexel

Countries where clinical trial is conducted

United States,  Argentina,  Bulgaria,  Croatia,  Germany,  Hungary,  India,  Italy,  Poland,  Romania,  Russian Federation,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication		0-24 hours
Secondary	Percentage of Patients With no Emesis		0-24 hours
Secondary	Percentage of Patients With no Rescue Medication		0-24 hours