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

Chemotherapy-Induced Nausea and Vomiting Clinical Trial

Official title:

A Phase 3, Single-dose, Multicenter, Randomized, Double-blind, Parallel Group Study to Assess the Efficacy and Safety 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 for the Prevention of Chemotherapy-induced Nausea and Vomiting in Cancer Patients Receiving Highly Emetogenic Chemotherapy.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02557035
• Other study ID #: PALO-15-17
• Status: Completed
• Phase: Phase 3
• Start date: October 2015
• Est. completion date: March 2016

Study information

• Verified date: June 2018
• Source: Helsinn Healthcare SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 441
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chemotherapy-Induced Nausea and Vomiting
• Nausea
• Vomiting

Intervention

Drug:
• Palonosetron

• Dexamethasone

Locations

Country	Name	City	State
Belarus	N.N. Aleksandrov Republican Research Oncology and Medical Radiology Center, Department of Chemotherapy	Lesnoy
Belarus	Minsk City Clinical Oncology Center	Minsk
Bosnia and Herzegovina	University Clinical Centre of the Republic of Srpska	Banja Luka
Bulgaria	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	Multiprofile Hospital for Active Treatment for Wonen's Health "Nadezhda"	Sofia
Bulgaria	University Multiprofile Hospital for Active Treatment "Sveti Ivan Rilski", Sofia, Department of Medical Oncology	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
Georgia	JSC NeoMedi	Tbilisi
Georgia	LDT High Technology Medical Center University Clinic	Tbilisi
Georgia	LTD Aversi Clinic	Tbilisi
Georgia	LTD Institute of Clinical Oncology	Tbilisi
Greece	"Sotiria" Chest Diseases Hospital of Athens	Athens
Greece	Bioclinic Thessalonikis S.A.	Thessaloniki
Greece	General Hospital of Thessaloniki "G. Papanikolaou", University Department of Pulmonology	Thessaloniki
Greece	Thermi Clinic S.A.	Thessaloniki
Hungary	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	Gyor
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	Pecs
Lithuania	Hospital of Lithuanian University of Health Sciences Kaunas Clinics, Clinic of Oncology and Hematology	Kaunas
Lithuania	Hospital of Lithuanian University of Health Sciences Kaunas Clinics, Oncology Hospital, Department of Conservative Oncology	Kaunas
Romania	Oncopremium Team SRL, Department of Oncology	Baia Mare
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. Alexandru Trestioreanu Institute of Oncology, Medical Oncology Department II	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	Constanta
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	Oncocenter Clinical Oncology SRL, Department of Medical Oncology	Timisoara
Romania	Oncomed SRL, Department of Medical Oncology	Timisoara
Russian Federation	Arkhangelsk Clinical Oncology Center	Arkhangelsk
Russian Federation	Altay Territorial Oncology Center	Barnaul
Russian Federation	Bryansk Regional Oncology Center	Bryansk
Russian Federation	Chelyabinsk Regional Clinical Oncology Center	Chelyabinsk
Russian Federation	Evimed, LLC	Chelyabinsk
Russian Federation	Sverdlovsk Regional Oncology Center	Ekaterinburg
Russian Federation	Ivanovo Regional Oncology Center	Ivanovo
Russian Federation	Kaluga Regional Oncology Center	Kaluga
Russian Federation	Republican Clinical Oncology Center	Kazan
Russian Federation	Krasnoyarsk A.I. Kryzhanovsky Regional Oncology Center	Krasnoyarsk
Russian Federation	Moscow City Oncology Hospital #62	Moscow
Russian Federation	Moscow Clinical Scientific and Practical Center	Moscow
Russian Federation	N.N. Blokhin Russian Oncology Research Center	Moscow
Russian Federation	N.N. Blokhin Russian Oncology Research Center, Surgery Dept. 2	Moscow
Russian Federation	N.N. Blokhin Russian Oncology Research Center, Surgery Dept. of Female Reproductive System Tumors	Moscow
Russian Federation	Branch #1 of Nizhny Novgorod Regional Oncology Center	Nizhny Novgorod
Russian Federation	City Clinical Hospital #1	Novosibirsk
Russian Federation	Novosibirsk Regional Oncology Center	Novosibirsk
Russian Federation	Clinical Oncology Center	Omsk
Russian Federation	Clinical Oncology Center, Dept. of Chemotherapy	Omsk
Russian Federation	Orenburg Regional Clinical Oncology Center	Orenburg
Russian Federation	Pyatigorsk Oncology Center	Pyatigorsk
Russian Federation	Regional Clinical Oncology Center	Ryazan
Russian Federation	Samara Regional Clinical Oncology Center	Samara
Russian Federation	City Clinical Oncology Center	St. Petersburg
Russian Federation	City Clinical Oncology Center, Thoracic Oncology Dept.	St. Petersburg
Russian Federation	City Clinical Oncology Center, Urology Oncology Dept.	St. Petersburg
Russian Federation	First I.P. Pavlov State Medical University of St. Petersburg	St. Petersburg
Russian Federation	St.Petersburg Municipal Clinical Oncology Center	St. Petersburg
Russian Federation	Tambov Regional Oncology Center	Tambov
Russian Federation	Tomsk Research Institute of Oncology	Tomsk
Russian Federation	Tomsk Research Institute of Oncology, General Oncology Dept.	Tomsk
Russian Federation	Republican Clinical Oncology Center	Ufa
Russian Federation	Regional Clinical Oncology Center	Veliky Novgorod

Sponsors (2)

Lead Sponsor	Collaborator
Helsinn Healthcare SA	PSI CRO AG

Countries where clinical trial is conducted

Belarus,  Bosnia and Herzegovina,  Bulgaria,  Georgia,  Greece,  Hungary,  Lithuania,  Romania,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication, in the Acute Phase		0-24 hours
Secondary	Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication, in the Delayed Phase		>24-120 hours
Secondary	Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication, in the Overall Phase		0-120 hours
Secondary	Percentage of Patients With no Emetic Episodes in the Acute Phase		0-24 hours
Secondary	Percentage of Patients With no Emetic Episodes in the Delayed Phase		>24-120 hours
Secondary	Percentage of Patients With no Emetic Episodes in the Overall Phase		0-120 hours
Secondary	Percentage of Patients With no Rescue Medication in the Acute Phase		0-24 hours
Secondary	Percentage of Patients With no Rescue Medication in the Delayed Phase		>24-120 hours
Secondary	Percentage of Patients With no Rescue Medication in the Overall Phase		0-120 hours