An Efficacy and Safety Study of Intravenous Palonosetron Administered as an Infusion and as a Bolus for the Prevention of Nausea and Vomiting

NCT ID: NCT02557035

Last Updated: 2018-06-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 441 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2016-03-31

Brief Summary

PALO-15-17 is a clinical study assessing efficacy and safety of a single dose of palonosetron 0.25 mg administered as a 30-minute IV infusion compared to palonosetron 0.25 mg administered as a 30-second IV bolus (Aloxi, an antiemetic drug), both given with oral dexamethasone. The objective of the study is to demonstrate that infused IV palonosetron 0.25 mg is as effective as (non-inferior to) injected 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

I.V. palonosetron infusion plus dexamethasone

Intravenous palonosetron (Aloxi 0.25 mg solution for injection) as an infusion 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

Palonosetron

Intervention Type: DRUG

Dexamethasone

Intervention Type: DRUG

I.V. palonosetron bolus plus dexamethasone

Intravenous palonosetron (Aloxi 0.25 mg solution for injection) as a bolus 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

Palonosetron

Intervention Type: DRUG

Dexamethasone

Intervention Type: DRUG

Interventions

Palonosetron

Intervention Type: DRUG

Dexamethasone

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Signed written informed consent
• Histologically or cytologically confirmed solid tumor malignancy.
• Naïve to cytotoxic chemotherapy. Previous biological or hormonal therapy will be permitted.
• Scheduled to receive first course of one of the following reference HEC, alone or in combination with other chemotherapeutic agents on Day 1:

• cisplatin administered as a single IV dose of ≥ 70 mg/m2
• cyclophosphamide ≥1500 mg/m2
• carmustine (BCNU) >250 mg/m2
• dacarbazine (DTIC)
• mechloretamine (nitrogen mustard)
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2 .
• If a patient is female, she shall be of non-childbearing potential or of childbearing potential using reliable contraceptive measures and having a negative urine pregnancy test.
• Hematologic and metabolic status adequate for receiving an highly emetogenic regimen based on laboratory criteria (Total Neutrophils,Platelets, Bilirubin, Liver enzymes, Serum Creatinine or Creatinine Clearance)
• Able to read, understand, follow the study procedure and complete patient diary.

Exclusion Criteria

• Lactating woman.
• Current use of illicit drugs or current evidence of alcohol abuse.
• Scheduled to receive moderately emetogenic chemotherapy or highly emetogenic chemotherapy from Day 2 to Day 5.
• Received or is scheduled to receive radiation therapy to the abdomen or the pelvis within 1 week prior to the start of the reference HEC administration on Day 1 or between Days 1 to 5.
• Any vomiting, retching, or nausea (grade ≥ 1 as defined by National Cancer Institute) within 24 hours prior to the start of the reference HEC administration on Day 1.
• Symptomatic primary or metastatic CNS malignancy.
• Active peptic ulcer disease, gastrointestinal obstruction, increased intracranial pressure, hypercalcemia, an active infection or any illness or 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) or pose unwarranted risks in administering the study drugs to the patient.
• Known hypersensitivity or contraindication to 5-HT3 receptor antagonists
• Known contraindication to the IV administration of 50 mL 5% glucose solution.
• Participation in a previous 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 present study.
• Systemic corticosteroid therapy at any dose within 72 hours prior to the start of the reference HEC administration on Day 1. However, topical and inhaled corticosteroids 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 the start of the reference HEC administration on Day 1, including but not limited to 5-HT3 receptor antagonists and NK-1 receptor antagonists
• Concurrent medical condition that would preclude administration of dexamethasone for 4 days such as systemic fungal infection or uncontrolled diabetes.

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

Sponsors

PSI CRO

INDUSTRY

Sponsor Role: collaborator

Helsinn Healthcare SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

N.N. Aleksandrov Republican Research Oncology and Medical Radiology Center, Department of Chemotherapy

Lesnoy, , Belarus

Minsk City Clinical Oncology Center

Minsk, , Belarus

University Clinical Centre of the Republic of Srpska

Banja Luka, , Bosnia and Herzegovina

Multiprofile Hospital for Active Treatment, Dobrich, Department of Medical Oncology

Dobrich, , Bulgaria

Specialized Hospital for Active Treatment in Oncology, Haskovo, Department of Medical Oncology

Haskovo, , Bulgaria

Multiprofile Hospital for Active Treatment "Central Onco Hospital", Plovdiv, Department of Medical Oncology

Plovdiv, , Bulgaria

Complex Oncology Center, Ruse, Department of Medical Oncology

Rousse, , Bulgaria

Multiprofile Hospital for Active Treatment "Serdika", Sofia, Department of Medical Oncology

Sofia, , Bulgaria

University Multiprofile Hospital for Active Treatment "Sveti Ivan Rilski", Sofia, Department of Medical Oncology

Sofia, , Bulgaria

Multiprofile Hospital for Active Treatment for Wonen's Health "Nadezhda"

Sofia, , Bulgaria

Hospital for Active Treatment of Oncological Diseases "Dr. Marko Antonov Markov", Varna, Department of Medicinal Oncology and Palliative Care

Varna, , Bulgaria

Multiprofile Hospital for Active Treatment "Sveta Marina", Varna, Clinic of Medical Oncology

Varna, , Bulgaria

JSC NeoMedi

Tbilisi, , Georgia

LTD Institute of Clinical Oncology

Tbilisi, , Georgia

LTD Aversi Clinic

Tbilisi, , Georgia

LDT High Technology Medical Center University Clinic

Tbilisi, , Georgia

"Sotiria" Chest Diseases Hospital of Athens

Athens, , Greece

Thermi Clinic S.A.

Thessaloniki, , Greece

General Hospital of Thessaloniki "G. Papanikolaou", University Department of Pulmonology

Thessaloniki, , Greece

Bioclinic Thessalonikis S.A.

Thessaloniki, , Greece

Koranyi National Institute of TBC and Pulmonology

Budapest, , Hungary

Uzsoki Hospital, Department of Radiation Oncology

Budapest, , Hungary

University of Debrecen, Medical and Health Science Center

Debrecen, , Hungary

Petz Aladar County Teaching Hospital, Center for Oncoradiology

Győr, , Hungary

Kaposi Mor Teaching Hospital, Centre for Clinical Oncology

Kaposvár, , Hungary

Borsod-Abauj-Zemplen County Hospital and University Educational Hospital

Miskolc, , Hungary

Szabolcs-Szatmar-Bereg County Hospitals and University Teaching Hospital

Nyíregyháza, , Hungary

Medical Center of the University of Pecs

Pécs, , Hungary

Hospital of Lithuanian University of Health Sciences Kaunas Clinics, Oncology Hospital, Department of Conservative Oncology

Kaunas, , Lithuania

Hospital of Lithuanian University of Health Sciences Kaunas Clinics, Clinic of Oncology and Hematology

Kaunas, , Lithuania

Oncopremium Team SRL, Department of Oncology

Baia Mare, , Romania

Prof. Dr. Alexandru Trestioreanu Institute of Oncology, Medical Oncology Department II

Bucharest, , Romania

Coltea Clinical Hospital, Department of Medical Oncology

Bucharest, , Romania

Hifu Terramed Conformal SRL, Department of Medical Oncology

Bucharest, , Romania

Ianuli Med Consult SRL, Oncology Department

Bucharest, , Romania

"Prof. Dr. Ion Chiricuta" Institute of Oncology, Radiotherapy Department I

Cluj-Napoca, , Romania

Radiotherapy Center Cluj SRL, Department of Oncology

Cluj-Napoca, , Romania

Constanta Emergency Clinical County Hospital, Department of Medical Oncology

Constanța, , Romania

Oncology Center "Sf. Nectarie", Department of Medical Oncology

Craiova, , Romania

Suceava Sf. Ioan cel Nou Emergency County Hospital, Department of Medical Oncology

Suceava, , Romania

Oncomed SRL, Department of Medical Oncology

Timișoara, , Romania

Oncocenter Clinical Oncology SRL, Department of Medical Oncology

Timișoara, , Romania

Arkhangelsk Clinical Oncology Center

Arkhangelsk, , Russia

Altay Territorial Oncology Center

Barnaul, , Russia

Bryansk Regional Oncology Center

Bryansk, , Russia

Chelyabinsk Regional Clinical Oncology Center

Chelyabinsk, , Russia

Evimed, LLC

Chelyabinsk, , Russia

Ivanovo Regional Oncology Center

Ivanovo, , Russia

Kaluga Regional Oncology Center

Kaluga, , Russia

Republican Clinical Oncology Center

Kazan', , Russia

Krasnoyarsk A.I. Kryzhanovsky Regional Oncology Center

Krasnoyarsk, , Russia

Moscow City Oncology Hospital #62

Moscow, , Russia

Moscow Clinical Scientific and Practical Center

Moscow, , Russia

N.N. Blokhin Russian Oncology Research Center, Surgery Dept. 2

Moscow, , Russia

N.N. Blokhin Russian Oncology Research Center, Surgery Dept. of Female Reproductive System Tumors

Moscow, , Russia

N.N. Blokhin Russian Oncology Research Center

Moscow, , Russia

Branch #1 of Nizhny Novgorod Regional Oncology Center

Nizhny Novgorod, , Russia

City Clinical Hospital #1

Novosibirsk, , Russia

Novosibirsk Regional Oncology Center

Novosibirsk, , Russia

Clinical Oncology Center, Dept. of Chemotherapy

Omsk, , Russia

Clinical Oncology Center

Omsk, , Russia

Orenburg Regional Clinical Oncology Center

Orenburg, , Russia

Pyatigorsk Oncology Center

Pyatigorsk, , Russia

Regional Clinical Oncology Center

Ryazan, , Russia

City Clinical Oncology Center, Thoracic Oncology Dept.

Saint Petersburg, , Russia

City Clinical Oncology Center, Urology Oncology Dept.

Saint Petersburg, , Russia

City Clinical Oncology Center

Saint Petersburg, , Russia

First I.P. Pavlov State Medical University of St. Petersburg

Saint Petersburg, , Russia

St.Petersburg Municipal Clinical Oncology Center

Saint Petersburg, , Russia

Samara Regional Clinical Oncology Center

Samara, , Russia

Tambov Regional Oncology Center

Tambov, , Russia

Tomsk Research Institute of Oncology, General Oncology Dept.

Tomsk, , Russia

Tomsk Research Institute of Oncology

Tomsk, , Russia

Republican Clinical Oncology Center

Ufa, , Russia

Regional Clinical Oncology Center

Veliky Novgorod, , Russia

Sverdlovsk Regional Oncology Center

Yekaterinburg, , Russia

Countries

Belarus; Bosnia and Herzegovina; Bulgaria; Georgia; Greece; Hungary; Lithuania; Romania; Russia

Other Identifiers

PALO-15-17

Identifier Type: -

Identifier Source: org_study_id