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

NCT02557035 | Completed Phase 3 Results

• 1 other identifier: PALO-15-17
• Study Type: interventional
• Target: 441
• Locations: 9 countries
• Sites: 76

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

Outcome Measures

Primary Outcomes (1)

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

  0-24 hours

Secondary Outcomes (8)

• 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 Complete Response (CR) Defined as no Emesis, no Rescue Medication, 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 Emetic Episodes in the Delayed Phase

  >24-120 hours

• Percentage of Patients With no Emetic Episodes in the Overall Phase

  0-120 hours

Study Arms (2)

I.V. palonosetron infusion plus dexamethasone

EXPERIMENTAL

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.

Drug: Palonosetron; Drug: Dexamethasone

I.V. palonosetron bolus plus dexamethasone

ACTIVE COMPARATOR

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.

Drug: Palonosetron; Drug: Dexamethasone

Interventions

Palonosetron DRUG

I.V. palonosetron bolus plus dexamethasone; I.V. palonosetron infusion plus dexamethasone

Dexamethasone DRUG

I.V. palonosetron bolus plus dexamethasone; I.V. palonosetron infusion plus dexamethasone

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Helsinn Healthcare SA: lead
• PSI CRO: collaborator

Study Sites (76)

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

Lesnoy, 223052, Belarus

Location

Minsk City Clinical Oncology Center

Minsk, 220013, Belarus

Location

University Clinical Centre of the Republic of Srpska

Banja Luka, Bosnia and Herzegovina

Location

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

Dobrich, 9300, Bulgaria

Location

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

Haskovo, 6300, Bulgaria

Location

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

Plovdiv, 4002, Bulgaria

Location

Complex Oncology Center, Ruse, Department of Medical Oncology

Rousse, 7002, Bulgaria

Location

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

Sofia, 1303, Bulgaria

Location

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

Sofia, 1431, Bulgaria

Location

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

Sofia, Bulgaria

Location

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

Varna, 9010, Bulgaria

Location

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

Varna, 9010, Bulgaria

Location

JSC NeoMedi

Tbilisi, 0131, Georgia

Location

LTD Institute of Clinical Oncology

Tbilisi, 0159, Georgia

Location

LTD Aversi Clinic

Tbilisi, 0160, Georgia

Location

LDT High Technology Medical Center University Clinic

Tbilisi, Georgia

Location

"Sotiria" Chest Diseases Hospital of Athens

Athens, Greece

Location

Thermi Clinic S.A.

Thessaloniki, 570 01, Greece

Location

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

Thessaloniki, 570 10, Greece

Location

Bioclinic Thessalonikis S.A.

Thessaloniki, Greece

Location

Koranyi National Institute of TBC and Pulmonology

Budapest, 1121, Hungary

Location

Uzsoki Hospital, Department of Radiation Oncology

Budapest, 1145, Hungary

Location

University of Debrecen, Medical and Health Science Center

Debrecen, Hungary

Location

Petz Aladar County Teaching Hospital, Center for Oncoradiology

Győr, 9024, Hungary

Location

Kaposi Mor Teaching Hospital, Centre for Clinical Oncology

Kaposvár, 7400, Hungary

Location

Borsod-Abauj-Zemplen County Hospital and University Educational Hospital

Miskolc, 3526, Hungary

Location

Szabolcs-Szatmar-Bereg County Hospitals and University Teaching Hospital

Nyíregyháza, Hungary

Location

Medical Center of the University of Pecs

Pécs, Hungary

Location

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

Kaunas, 45434, Lithuania

Location

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

Kaunas, 50009, Lithuania

Location

Oncopremium Team SRL, Department of Oncology

Baia Mare, Romania

Location

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

Bucharest, 022328, Romania

Location

Coltea Clinical Hospital, Department of Medical Oncology

Bucharest, 030171, Romania

Location

Hifu Terramed Conformal SRL, Department of Medical Oncology

Bucharest, 031864, Romania

Location

Ianuli Med Consult SRL, Oncology Department

Bucharest, Romania

Location

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

Cluj-Napoca, 400015, Romania

Location

Radiotherapy Center Cluj SRL, Department of Oncology

Cluj-Napoca, Romania

Location

Constanta Emergency Clinical County Hospital, Department of Medical Oncology

Constanța, 900591, Romania

Location

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

Craiova, Romania

Location

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

Suceava, 720237, Romania

Location

Oncomed SRL, Department of Medical Oncology

Timișoara, 300239, Romania

Location

Oncocenter Clinical Oncology SRL, Department of Medical Oncology

Timișoara, Romania

Location

Arkhangelsk Clinical Oncology Center

Arkhangelsk, Russia

Location

Altay Territorial Oncology Center

Barnaul, Russia

Location

Bryansk Regional Oncology Center

Bryansk, Russia

Location

Chelyabinsk Regional Clinical Oncology Center

Chelyabinsk, Russia

Location

Evimed, LLC

Chelyabinsk, Russia

Location

Ivanovo Regional Oncology Center

Ivanovo, Russia

Location

Kaluga Regional Oncology Center

Kaluga, Russia

Location

Republican Clinical Oncology Center

Kazan', Russia

Location

Krasnoyarsk A.I. Kryzhanovsky Regional Oncology Center

Krasnoyarsk, Russia

Location

Moscow City Oncology Hospital #62

Moscow, Russia

Location

Moscow Clinical Scientific and Practical Center

Moscow, Russia

Location

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

Moscow, Russia

Location

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

Moscow, Russia

Location

N.N. Blokhin Russian Oncology Research Center

Moscow, Russia

Location

Branch #1 of Nizhny Novgorod Regional Oncology Center

Nizhny Novgorod, Russia

Location

City Clinical Hospital #1

Novosibirsk, Russia

Location

Novosibirsk Regional Oncology Center

Novosibirsk, Russia

Location

Clinical Oncology Center, Dept. of Chemotherapy

Omsk, Russia

Location

Clinical Oncology Center

Omsk, Russia

Location

Orenburg Regional Clinical Oncology Center

Orenburg, Russia

Location

Pyatigorsk Oncology Center

Pyatigorsk, Russia

Location

Regional Clinical Oncology Center

Ryazan, Russia

Location

City Clinical Oncology Center, Thoracic Oncology Dept.

Saint Petersburg, Russia

Location

City Clinical Oncology Center, Urology Oncology Dept.

Saint Petersburg, Russia

Location

City Clinical Oncology Center

Saint Petersburg, Russia

Location

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

Saint Petersburg, Russia

Location

St.Petersburg Municipal Clinical Oncology Center

Saint Petersburg, Russia

Location

Samara Regional Clinical Oncology Center

Samara, Russia

Location

Tambov Regional Oncology Center

Tambov, Russia

Location

Tomsk Research Institute of Oncology, General Oncology Dept.

Tomsk, Russia

Location

Tomsk Research Institute of Oncology

Tomsk, Russia

Location

Republican Clinical Oncology Center

Ufa, Russia

Location

Regional Clinical Oncology Center

Veliky Novgorod, Russia

Location

Sverdlovsk Regional Oncology Center

Yekaterinburg, Russia

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: Daniel Voisin
• Organization: Helsinn Healthcare SA

daniel.voisin@helsinn.com

+41 91 985 2121

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• 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: September 21, 2015
• First Posted: September 22, 2015
• Study Start: October 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: June 20, 2018
• Results First Posted: June 20, 2018

Record last verified: 2018-06

Locations

HU (8); LI (2); BU (9); BE (2); BO (1); GE (4); GR (4); RO (12); RU (34)