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

Phase 3

Completed

• Conditions: Chemotherapy-Induced Nausea and Vomiting
• Interventions: Drug: Palonosetron; Drug: Dexamethasone

• Registration Number: NCT02557035
• Lead Sponsor: Helsinn Healthcare SA

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-09-21
• Study First Submitted QC: 2015-09-21
• Study First Posted: 2015-09-22
• Study Start: 2015-10
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Disposition First Submitted: 2016-03-23
• Disposition First Submitted QC: 2016-03-23
• Disposition First Posted: 2016-04-26
• Results First Submitted: 2018-05-09
• Status Verified: 2018-06
• Results First Submitted QC: 2018-06-18
• Last Update Submitted: 2018-06-18
• Results First Posted: 2018-06-20
• Last Update Posted: 2018-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 441

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
I.V. palonosetron infusion plus dexamethasone	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.
I.V. palonosetron infusion plus dexamethasone	Palonosetron	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.
I.V. palonosetron bolus plus dexamethasone	Palonosetron	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.
I.V. palonosetron bolus plus dexamethasone	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.

Primary Outcome Measures

Name	Time	Method
Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication, in the Acute Phase	0-24 hours

Secondary Outcome Measures

Name	Time	Method
Percentage of Patients With no Emetic Episodes in the Overall Phase	0-120 hours
Percentage of Patients With no Emetic Episodes in the Acute Phase	0-24 hours
Percentage of Patients With no Rescue Medication in the Acute Phase	0-24 hours
Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication, in the Delayed Phase	>24-120 hours
Percentage of Patients With no Emetic Episodes in the Delayed Phase	>24-120 hours
Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication, in the Overall Phase	0-120 hours
Percentage of Patients With no Rescue Medication in the Delayed Phase	>24-120 hours
Percentage of Patients With no Rescue Medication in the Overall Phase	0-120 hours

Trial Locations

Locations (74)

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

Multiprofile Hospital for Active Treatment "Serdika", Sofia, Department of Medical Oncology; 🇧🇬 Sofia, Bulgaria

Bioclinic Thessalonikis S.A.; 🇬🇷 Thessaloniki, Greece

Moscow City Oncology Hospital #62; 🇷🇺 Moscow, Russian Federation

City Clinical Oncology Center, Thoracic Oncology Dept.; 🇷🇺 St. Petersburg, Russian Federation

St.Petersburg Municipal Clinical Oncology Center; 🇷🇺 St. Petersburg, Russian Federation

Tambov Regional Oncology Center; 🇷🇺 Tambov, Russian Federation

Multiprofile Hospital for Active Treatment, Dobrich, Department of Medical Oncology; 🇧🇬 Dobrich, Bulgaria

N.N. Aleksandrov Republican Research Oncology and Medical Radiology Center, Department of Chemotherapy; 🇧🇾 Lesnoy, Belarus

Minsk City Clinical Oncology Center; 🇧🇾 Minsk, Belarus

Complex Oncology Center, Ruse, Department of Medical Oncology; 🇧🇬 Rousse, Bulgaria

University Clinical Centre of the Republic of Srpska; 🇧🇦 Banja Luka, Bosnia and Herzegovina

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

"Sotiria" Chest Diseases Hospital of Athens; 🇬🇷 Athens, Greece

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

Thermi Clinic S.A.; 🇬🇷 Thessaloniki, Greece

Koranyi National Institute of TBC and Pulmonology; 🇭🇺 Budapest, Hungary

Kaposi Mor Teaching Hospital, Centre for Clinical Oncology; 🇭🇺 Kaposvár, Hungary

Borsod-Abauj-Zemplen County Hospital and University Educational Hospital; 🇭🇺 Miskolc, Hungary

Bryansk Regional Oncology Center; 🇷🇺 Bryansk, Russian Federation

Novosibirsk Regional Oncology Center; 🇷🇺 Novosibirsk, Russian Federation

First I.P. Pavlov State Medical University of St. Petersburg; 🇷🇺 St. Petersburg, Russian Federation

General Hospital of Thessaloniki "G. Papanikolaou", University Department of Pulmonology; 🇬🇷 Thessaloniki, Greece

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

Szabolcs-Szatmar-Bereg County Hospitals and University Teaching Hospital; 🇭🇺 Nyíregyháza, Hungary

Medical Center of the University of Pecs; 🇭🇺 Pecs, Hungary

Hospital of Lithuanian University of Health Sciences Kaunas Clinics, Oncology Hospital, Department of Conservative Oncology; 🇱🇹 Kaunas, Lithuania

Oncopremium Team SRL, Department of Oncology; 🇷🇴 Baia Mare, Romania

Coltea Clinical Hospital, Department of Medical Oncology; 🇷🇴 Bucharest, Romania

Hospital of Lithuanian University of Health Sciences Kaunas Clinics, Clinic of Oncology and Hematology; 🇱🇹 Kaunas, Lithuania

Prof. Dr. Alexandru Trestioreanu Institute of Oncology, Medical Oncology Department II; 🇷🇴 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; 🇷🇴 Constanta, Romania

Oncology Center "Sf. Nectarie", Department of Medical Oncology; 🇷🇴 Craiova, Romania

Oncocenter Clinical Oncology SRL, Department of Medical Oncology; 🇷🇴 Timisoara, Romania

Suceava Sf. Ioan cel Nou Emergency County Hospital, Department of Medical Oncology; 🇷🇴 Suceava, Romania

Sverdlovsk Regional Oncology Center; 🇷🇺 Ekaterinburg, Russian Federation

Krasnoyarsk A.I. Kryzhanovsky Regional Oncology Center; 🇷🇺 Krasnoyarsk, Russian Federation

N.N. Blokhin Russian Oncology Research Center, Surgery Dept. of Female Reproductive System Tumors; 🇷🇺 Moscow, Russian Federation

Oncomed SRL, Department of Medical Oncology; 🇷🇴 Timisoara, Romania

City Clinical Hospital #1; 🇷🇺 Novosibirsk, Russian Federation

N.N. Blokhin Russian Oncology Research Center, Surgery Dept. 2; 🇷🇺 Moscow, Russian Federation

Arkhangelsk Clinical Oncology Center; 🇷🇺 Arkhangelsk, Russian Federation

Ivanovo Regional Oncology Center; 🇷🇺 Ivanovo, Russian Federation

Kaluga Regional Oncology Center; 🇷🇺 Kaluga, Russian Federation

Republican Clinical Oncology Center; 🇷🇺 Ufa, Russian Federation

Branch #1 of Nizhny Novgorod Regional Oncology Center; 🇷🇺 Nizhny Novgorod, Russian Federation

Altay Territorial Oncology Center; 🇷🇺 Barnaul, Russian Federation

Moscow Clinical Scientific and Practical Center; 🇷🇺 Moscow, Russian Federation

Chelyabinsk Regional Clinical Oncology Center; 🇷🇺 Chelyabinsk, Russian Federation

Evimed, LLC; 🇷🇺 Chelyabinsk, Russian Federation

Clinical Oncology Center; 🇷🇺 Omsk, Russian Federation

Tomsk Research Institute of Oncology, General Oncology Dept.; 🇷🇺 Tomsk, Russian Federation

N.N. Blokhin Russian Oncology Research Center; 🇷🇺 Moscow, Russian Federation

Orenburg Regional Clinical Oncology Center; 🇷🇺 Orenburg, Russian Federation

Samara Regional Clinical Oncology Center; 🇷🇺 Samara, Russian Federation

City Clinical Oncology Center; 🇷🇺 St. Petersburg, Russian Federation

Clinical Oncology Center, Dept. of Chemotherapy; 🇷🇺 Omsk, Russian Federation

Pyatigorsk Oncology Center; 🇷🇺 Pyatigorsk, Russian Federation

Regional Clinical Oncology Center; 🇷🇺 Veliky Novgorod, Russian Federation

City Clinical Oncology Center, Urology Oncology Dept.; 🇷🇺 St. Petersburg, Russian Federation

Tomsk Research Institute of Oncology; 🇷🇺 Tomsk, Russian Federation