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

NCT01363479 | Completed Phase 3 Results

• 1 other identifier: PALO-10-01
• Study Type: interventional
• Target: 743
• Locations: 12 countries
• Sites: 79

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

Outcome Measures

Primary Outcomes (1)

• Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication

  0-24 hours

Secondary Outcomes (2)

• Percentage of Patients With no Emesis

  0-24 hours

• Percentage of Patients With no Rescue Medication

  0-24 hours

Study Arms (2)

Oral palonosteron plus dexamethasone

EXPERIMENTAL

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: Oral palonosetron; Drug: Dexamethasone

I.V. palonosetron plus dexamethasone

ACTIVE COMPARATOR

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: I.V. palonosetron; Drug: Dexamethasone

Interventions

Oral palonosetron DRUG

Oral palonosteron plus dexamethasone

I.V. palonosetron DRUG

I.V. palonosetron plus dexamethasone

Dexamethasone DRUG

I.V. palonosetron plus dexamethasone; Oral palonosteron plus dexamethasone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Helsinn Healthcare SA: lead
• Parexel: collaborator

Study Sites (79)

Genesis Cancer Centre

Hot Springs, Arkansas, 71913, United States

Location

Compassionate Cancer Center

Corona, California, 92879, United States

Location

Compassionate Cancer Centre Medical Group

Fountain Valley, California, 92708, United States

Location

Facey Medical Group

Mission Hills, California, 91345, United States

Location

Compassionate Cancer Care Medical Group

Riverside, California, 92501, United States

Location

Signal Point Clinical Research Center, LLC

Middletown, Ohio, 45042, United States

Location

Wellmont Medical Associates-Oncology and Hematology

Bristol, Rhode Island, 37620, United States

Location

Charleston Hematology Oncology

Charleston, South Carolina, 29414, United States

Location

Northern Utah Associates [Hematology/ Oncology]

Ogden, Utah, 84403, United States

Location

Centro Oncológico Integral (COI)

Mar del Plata, Buenos Aires, 7600, Argentina

Location

Clínica Universitaria Reina Fabiola

Córdoba, X5004FHP, Argentina

Location

Instituto Oncológico de Córdoba (IONC)

Córdoba, X5006HBF, Argentina

Location

Instituto Médico CER [Oncology]

Quilmes, B1878DVB, Argentina

Location

Sanatorio Parque

Rosario, 2000, Argentina

Location

Centro Medico San Roque

San Miguel de Tucumán, T4000AIK, Argentina

Location

ISIS Clinica Especializada

Santa Fe, 3000, Argentina

Location

MHAT Dr. Tota Venkova

Gabrovo, 5300, Bulgaria

Location

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

Sofia, 1233, Bulgaria

Location

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

Sofia, 1572, Bulgaria

Location

Specialised Hospital for Active treatment on Oncology

Sofia, 1756, Bulgaria

Location

District Dispensery for Oncology Diseases with in-patient

Sofia, 6300, Bulgaria

Location

Complex Oncology Centre

Stara Zagora, 6003, Bulgaria

Location

Klinicki bolnicki centar [Oncology]

Osijek, 31000, Croatia

Location

KBC Rijeka

Rijeka, 51000, Croatia

Location

Opca bolnica Varazdin

Varaždin, 42000, Croatia

Location

KBC Zagreb

Zagreb, 10000, Croatia

Location

Klinicka bolnica [Sestre milosrdnice]

Zagreb, 10000, Croatia

Location

Klinik und Poliklinik für Onkologie und Hämatologie Universitätsmedizin Charité Mitte

Berlin, 10117, Germany

Location

OncoResearch Lerchenfeld UG

Hamburg, 22081, Germany

Location

Städtisches Klinikum München

München, 81545, Germany

Location

Staedtisches Krankenhaus Muenchen Neuperlach

München, 81737, Germany

Location

Semmelweis Egyetem Kútvölgyi Klinikai Tömb

Budapest, 1125, Hungary

Location

Fővárosi Önkormányzat Uzsoki utcai Kórház

Budapest, 1145, Hungary

Location

Petz Aladár Megyei Oktató Kórház

Győr, 9024, Hungary

Location

Bács-Kiskun Megyei Önkormányzat Kórháza, Szeged

Kecskemét, 6000, Hungary

Location

Pécsi Tudományegyetem [Onkoterápiás Intézet]

Pécs, 7624, Hungary

Location

Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz

Szolnok, 5004, Hungary

Location

Yashoda Super speciality Hospital

Hyderabad, Andhra Pradesh, 500 082, India

Location

Sujan Surgical Cancer Hospital and Amracvati Cancer Foundation

Pune, Maharashtra, 444605, India

Location

Apollo Speciality Hospital

Chennai, Tamil Nadu, 600035, India

Location

Sri Venkateshwara Hospital [Medical Oncology]

Bangalore, 560068, India

Location

Chinmaya Mission Hospital

Bangalore, 632004, India

Location

City Cancer Centre [Surgical and Medical Oncology]

Vijayawada, 520002, India

Location

Fondazione Poliambulanza Istituto Ospedaliero

Brescia, 25124, Italy

Location

Ospedale Vito Fazzi - ASL Lecce

Lecce, 73100, Italy

Location

Presidio Ospedaliero "Alessandro Manzoni"

Lecco, 23900, Italy

Location

AO Regionale S.Carlo di Potenza

Potenza, 85100, Italy

Location

Szpital Wojewodzki Zespolony

Elblag, 82-300, Poland

Location

Wojewodzki Szpital Specjalistyczny im. M.Kopernika

Lodz, 93-509, Poland

Location

Wojewodzki Szpital Specjalistyczny im. J. Korczaka

Słupsk, 76-200, Poland

Location

Centrum Onkologii - Instytut im. Marii Sklodowskiej - Curie

Warsaw, 02-781, Poland

Location

NZOZ Magodent - Centrum Medczyne Ostrobramska

Warsaw, 04-125, Poland

Location

Szpital Wojewodzki w Lomzy im. Kardynala S. Wyszynskiego

Łomża, 18-400, Poland

Location

Spitalul Judetean de Urgenta "Dr. Constantin Opris"

Baia Mare, 430031, Romania

Location

Institutul Oncologic "Prof. Dr. Alex. Trestioreanu"

Bucharest, 22328, Romania

Location

Institutul Oncologic "Prof. Dr. Ion Chiricuta"

Cluj-Napoca, 400015, Romania

Location

Spitalul Clinic Judetean de Urgenta Cluj (Oncologie Medicala)

Cluj-Napoca, 400349, Romania

Location

Centrul de Oncologie Euroclinic

Iași, 700106, Romania

Location

Institutul Regional de Oncologie Iasi

Iași, 700483, Romania

Location

Spitalul Clinic Judetean de Urgenta Sibiu [Oncologie]

Sibiu, 550245, Romania

Location

Oncomed SRL

Timișoara, 300239, Romania

Location

GUZ Arkhangelsk Regional Clinical Oncological Dispensary

Arkhangelsk, 163045, Russia

Location

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

Krasnoyarsk, 660022, Russia

Location

GUZ Lipetsk Regional Oncology Dispensary [General Oncology]

Lipetsk, 398005, Russia

Location

GUZ Regional Oncology Dispensary #2

Magnitogorsk, 455001, Russia

Location

RAMN - Russian Cancer Research Center

Moscow, 115478, Russia

Location

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

Moscow, 115478, Russia

Location

MBUZ City Clinical Hospital #1 [Oncology]

Novosibirsk, 630047, Russia

Location

FGBU "Medical Radiology Scientific Center of Minzdravsotsrazvitiya RF

Obninsk, 249036, Russia

Location

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

Ryazan, 390026, Russia

Location

GUZ Leningrad Regional Oncological Dispensary

Saint Petersburg, 188663, Russia

Location

St. Petersburg Clinical Oncology Dispesary

Saint Petersburg, 197022, Russia

Location

Komunalnyi likuvalno-profilaktychnyi zaklad "Chernigivskyi

Chernihiv, 14029, Ukraine

Location

Komunalnyi zaklad Miska bahatoprofilna klinichna likarnia #4

Dnipropetrovsk, 49102, Ukraine

Location

Komunalno-klinichnyi likuvalno-profilaktychnyi zaklad

Donetsk, 83092, Ukraine

Location

DU IMR AMNU [vd khemter]

Kharkiv, 61024, Ukraine

Location

Kharkivskyi oblasnyi onkologichnyi klinichnyi tsentr

Kharkiv, 61070, Ukraine

Location

Chmelnytskyi Regional Clinical Oncology Centre [Oncology]

Khmelnytskyi, 29009, Ukraine

Location

Uzhgorod National University

Uzhhorod, 88000, Ukraine

Location

MeSH Terms

Conditions

Vomiting

Interventions

Palonosetron; Dexamethasone

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: Marco Palmas MD, Head of Clinical Development
• Organization: Helsinn Healthcare SA

marco.palmas@helsinn.com

+41919852121

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2011
• First Posted: June 1, 2011
• Study Start: July 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: September 22, 2021
• Results First Posted: November 17, 2014

Record last verified: 2021-08

Locations

DE (4); IT (4); PL (6); HU (6); IN (6); US (9); BU (6); RO (8); RU (11); UA (7); CR (5); AR (7)