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

Primary Purpose

Chemotherapy-Induced Nausea and Vomiting

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Palonosetron
Dexamethasone
Sponsored by
Helsinn Healthcare SA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chemotherapy-Induced Nausea and Vomiting

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • N.N. Aleksandrov Republican Research Oncology and Medical Radiology Center, Department of Chemotherapy
  • Minsk City Clinical Oncology Center
  • University Clinical Centre of the Republic of Srpska
  • Multiprofile Hospital for Active Treatment, Dobrich, Department of Medical Oncology
  • Specialized Hospital for Active Treatment in Oncology, Haskovo, Department of Medical Oncology
  • Multiprofile Hospital for Active Treatment "Central Onco Hospital", Plovdiv, Department of Medical Oncology
  • Complex Oncology Center, Ruse, Department of Medical Oncology
  • Multiprofile Hospital for Active Treatment "Serdika", Sofia, Department of Medical Oncology
  • University Multiprofile Hospital for Active Treatment "Sveti Ivan Rilski", Sofia, Department of Medical Oncology
  • Multiprofile Hospital for Active Treatment for Wonen's Health "Nadezhda"
  • Hospital for Active Treatment of Oncological Diseases "Dr. Marko Antonov Markov", Varna, Department of Medicinal Oncology and Palliative Care
  • Multiprofile Hospital for Active Treatment "Sveta Marina", Varna, Clinic of Medical Oncology
  • JSC NeoMedi
  • LTD Institute of Clinical Oncology
  • LTD Aversi Clinic
  • LDT High Technology Medical Center University Clinic
  • "Sotiria" Chest Diseases Hospital of Athens
  • Thermi Clinic S.A.
  • General Hospital of Thessaloniki "G. Papanikolaou", University Department of Pulmonology
  • Bioclinic Thessalonikis S.A.
  • Koranyi National Institute of TBC and Pulmonology
  • Uzsoki Hospital, Department of Radiation Oncology
  • University of Debrecen, Medical and Health Science Center
  • Petz Aladar County Teaching Hospital, Center for Oncoradiology
  • Kaposi Mor Teaching Hospital, Centre for Clinical Oncology
  • Borsod-Abauj-Zemplen County Hospital and University Educational Hospital
  • Szabolcs-Szatmar-Bereg County Hospitals and University Teaching Hospital
  • Medical Center of the University of Pecs
  • Hospital of Lithuanian University of Health Sciences Kaunas Clinics, Oncology Hospital, Department of Conservative Oncology
  • Hospital of Lithuanian University of Health Sciences Kaunas Clinics, Clinic of Oncology and Hematology
  • Oncopremium Team SRL, Department of Oncology
  • Prof. Dr. Alexandru Trestioreanu Institute of Oncology, Medical Oncology Department II
  • Coltea Clinical Hospital, Department of Medical Oncology
  • Hifu Terramed Conformal SRL, Department of Medical Oncology
  • Ianuli Med Consult SRL, Oncology Department
  • "Prof. Dr. Ion Chiricuta" Institute of Oncology, Radiotherapy Department I
  • Radiotherapy Center Cluj SRL, Department of Oncology
  • Constanta Emergency Clinical County Hospital, Department of Medical Oncology
  • Oncology Center "Sf. Nectarie", Department of Medical Oncology
  • Suceava Sf. Ioan cel Nou Emergency County Hospital, Department of Medical Oncology
  • Oncomed SRL, Department of Medical Oncology
  • Oncocenter Clinical Oncology SRL, Department of Medical Oncology
  • Arkhangelsk Clinical Oncology Center
  • Altay Territorial Oncology Center
  • Bryansk Regional Oncology Center
  • Chelyabinsk Regional Clinical Oncology Center
  • Evimed, LLC
  • Sverdlovsk Regional Oncology Center
  • Ivanovo Regional Oncology Center
  • Kaluga Regional Oncology Center
  • Republican Clinical Oncology Center
  • Krasnoyarsk A.I. Kryzhanovsky Regional Oncology Center
  • Moscow City Oncology Hospital #62
  • Moscow Clinical Scientific and Practical Center
  • N.N. Blokhin Russian Oncology Research Center, Surgery Dept. 2
  • N.N. Blokhin Russian Oncology Research Center, Surgery Dept. of Female Reproductive System Tumors
  • N.N. Blokhin Russian Oncology Research Center
  • Branch #1 of Nizhny Novgorod Regional Oncology Center
  • City Clinical Hospital #1
  • Novosibirsk Regional Oncology Center
  • Clinical Oncology Center, Dept. of Chemotherapy
  • Clinical Oncology Center
  • Orenburg Regional Clinical Oncology Center
  • Pyatigorsk Oncology Center
  • Regional Clinical Oncology Center
  • Samara Regional Clinical Oncology Center
  • City Clinical Oncology Center, Thoracic Oncology Dept.
  • City Clinical Oncology Center, Urology Oncology Dept.
  • City Clinical Oncology Center
  • First I.P. Pavlov State Medical University of St. Petersburg
  • St.Petersburg Municipal Clinical Oncology Center
  • Tambov Regional Oncology Center
  • Tomsk Research Institute of Oncology, General Oncology Dept.
  • Tomsk Research Institute of Oncology
  • Republican Clinical Oncology Center
  • Regional Clinical Oncology Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

I.V. palonosetron infusion plus dexamethasone

I.V. palonosetron bolus plus dexamethasone

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 21, 2015
Last Updated
June 18, 2018
Sponsor
Helsinn Healthcare SA
Collaborators
PSI CRO
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1. Study Identification

Unique Protocol Identification Number
NCT02557035
Brief Title
An Efficacy and Safety Study of Intravenous Palonosetron Administered as an Infusion and as a Bolus for the Prevention of Nausea and Vomiting
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.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Helsinn Healthcare SA
Collaborators
PSI CRO

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chemotherapy-Induced Nausea and Vomiting

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
441 (Actual)

8. Arms, Groups, and Interventions

Arm Title
I.V. palonosetron infusion plus dexamethasone
Arm Type
Experimental
Arm Description
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.
Arm Title
I.V. palonosetron bolus plus dexamethasone
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Palonosetron
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Primary Outcome Measure Information:
Title
Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication, in the Acute Phase
Time Frame
0-24 hours
Secondary Outcome Measure Information:
Title
Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication, in the Delayed Phase
Time Frame
>24-120 hours
Title
Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication, in the Overall Phase
Time Frame
0-120 hours
Title
Percentage of Patients With no Emetic Episodes in the Acute Phase
Time Frame
0-24 hours
Title
Percentage of Patients With no Emetic Episodes in the Delayed Phase
Time Frame
>24-120 hours
Title
Percentage of Patients With no Emetic Episodes in the Overall Phase
Time Frame
0-120 hours
Title
Percentage of Patients With no Rescue Medication in the Acute Phase
Time Frame
0-24 hours
Title
Percentage of Patients With no Rescue Medication in the Delayed Phase
Time Frame
>24-120 hours
Title
Percentage of Patients With no Rescue Medication in the Overall Phase
Time Frame
0-120 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
N.N. Aleksandrov Republican Research Oncology and Medical Radiology Center, Department of Chemotherapy
City
Lesnoy
ZIP/Postal Code
223052
Country
Belarus
Facility Name
Minsk City Clinical Oncology Center
City
Minsk
ZIP/Postal Code
220013
Country
Belarus
Facility Name
University Clinical Centre of the Republic of Srpska
City
Banja Luka
Country
Bosnia and Herzegovina
Facility Name
Multiprofile Hospital for Active Treatment, Dobrich, Department of Medical Oncology
City
Dobrich
ZIP/Postal Code
9300
Country
Bulgaria
Facility Name
Specialized Hospital for Active Treatment in Oncology, Haskovo, Department of Medical Oncology
City
Haskovo
ZIP/Postal Code
6300
Country
Bulgaria
Facility Name
Multiprofile Hospital for Active Treatment "Central Onco Hospital", Plovdiv, Department of Medical Oncology
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
Facility Name
Complex Oncology Center, Ruse, Department of Medical Oncology
City
Rousse
ZIP/Postal Code
7002
Country
Bulgaria
Facility Name
Multiprofile Hospital for Active Treatment "Serdika", Sofia, Department of Medical Oncology
City
Sofia
ZIP/Postal Code
1303
Country
Bulgaria
Facility Name
University Multiprofile Hospital for Active Treatment "Sveti Ivan Rilski", Sofia, Department of Medical Oncology
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
Multiprofile Hospital for Active Treatment for Wonen's Health "Nadezhda"
City
Sofia
Country
Bulgaria
Facility Name
Hospital for Active Treatment of Oncological Diseases "Dr. Marko Antonov Markov", Varna, Department of Medicinal Oncology and Palliative Care
City
Varna
ZIP/Postal Code
9010
Country
Bulgaria
Facility Name
Multiprofile Hospital for Active Treatment "Sveta Marina", Varna, Clinic of Medical Oncology
City
Varna
ZIP/Postal Code
9010
Country
Bulgaria
Facility Name
JSC NeoMedi
City
Tbilisi
ZIP/Postal Code
0131
Country
Georgia
Facility Name
LTD Institute of Clinical Oncology
City
Tbilisi
ZIP/Postal Code
0159
Country
Georgia
Facility Name
LTD Aversi Clinic
City
Tbilisi
ZIP/Postal Code
0160
Country
Georgia
Facility Name
LDT High Technology Medical Center University Clinic
City
Tbilisi
Country
Georgia
Facility Name
"Sotiria" Chest Diseases Hospital of Athens
City
Athens
Country
Greece
Facility Name
Thermi Clinic S.A.
City
Thessaloniki
ZIP/Postal Code
570 01
Country
Greece
Facility Name
General Hospital of Thessaloniki "G. Papanikolaou", University Department of Pulmonology
City
Thessaloniki
ZIP/Postal Code
570 10
Country
Greece
Facility Name
Bioclinic Thessalonikis S.A.
City
Thessaloniki
Country
Greece
Facility Name
Koranyi National Institute of TBC and Pulmonology
City
Budapest
ZIP/Postal Code
1121
Country
Hungary
Facility Name
Uzsoki Hospital, Department of Radiation Oncology
City
Budapest
ZIP/Postal Code
1145
Country
Hungary
Facility Name
University of Debrecen, Medical and Health Science Center
City
Debrecen
Country
Hungary
Facility Name
Petz Aladar County Teaching Hospital, Center for Oncoradiology
City
Gyor
ZIP/Postal Code
9024
Country
Hungary
Facility Name
Kaposi Mor Teaching Hospital, Centre for Clinical Oncology
City
Kaposvár
ZIP/Postal Code
7400
Country
Hungary
Facility Name
Borsod-Abauj-Zemplen County Hospital and University Educational Hospital
City
Miskolc
ZIP/Postal Code
3526
Country
Hungary
Facility Name
Szabolcs-Szatmar-Bereg County Hospitals and University Teaching Hospital
City
Nyíregyháza
Country
Hungary
Facility Name
Medical Center of the University of Pecs
City
Pecs
Country
Hungary
Facility Name
Hospital of Lithuanian University of Health Sciences Kaunas Clinics, Oncology Hospital, Department of Conservative Oncology
City
Kaunas
ZIP/Postal Code
45434
Country
Lithuania
Facility Name
Hospital of Lithuanian University of Health Sciences Kaunas Clinics, Clinic of Oncology and Hematology
City
Kaunas
ZIP/Postal Code
50009
Country
Lithuania
Facility Name
Oncopremium Team SRL, Department of Oncology
City
Baia Mare
Country
Romania
Facility Name
Prof. Dr. Alexandru Trestioreanu Institute of Oncology, Medical Oncology Department II
City
Bucharest
ZIP/Postal Code
022328
Country
Romania
Facility Name
Coltea Clinical Hospital, Department of Medical Oncology
City
Bucharest
ZIP/Postal Code
030171
Country
Romania
Facility Name
Hifu Terramed Conformal SRL, Department of Medical Oncology
City
Bucharest
ZIP/Postal Code
031864
Country
Romania
Facility Name
Ianuli Med Consult SRL, Oncology Department
City
Bucharest
Country
Romania
Facility Name
"Prof. Dr. Ion Chiricuta" Institute of Oncology, Radiotherapy Department I
City
Cluj-Napoca
ZIP/Postal Code
400015
Country
Romania
Facility Name
Radiotherapy Center Cluj SRL, Department of Oncology
City
Cluj-Napoca
Country
Romania
Facility Name
Constanta Emergency Clinical County Hospital, Department of Medical Oncology
City
Constanta
ZIP/Postal Code
900591
Country
Romania
Facility Name
Oncology Center "Sf. Nectarie", Department of Medical Oncology
City
Craiova
Country
Romania
Facility Name
Suceava Sf. Ioan cel Nou Emergency County Hospital, Department of Medical Oncology
City
Suceava
ZIP/Postal Code
720237
Country
Romania
Facility Name
Oncomed SRL, Department of Medical Oncology
City
Timisoara
ZIP/Postal Code
300239
Country
Romania
Facility Name
Oncocenter Clinical Oncology SRL, Department of Medical Oncology
City
Timisoara
Country
Romania
Facility Name
Arkhangelsk Clinical Oncology Center
City
Arkhangelsk
Country
Russian Federation
Facility Name
Altay Territorial Oncology Center
City
Barnaul
Country
Russian Federation
Facility Name
Bryansk Regional Oncology Center
City
Bryansk
Country
Russian Federation
Facility Name
Chelyabinsk Regional Clinical Oncology Center
City
Chelyabinsk
Country
Russian Federation
Facility Name
Evimed, LLC
City
Chelyabinsk
Country
Russian Federation
Facility Name
Sverdlovsk Regional Oncology Center
City
Ekaterinburg
Country
Russian Federation
Facility Name
Ivanovo Regional Oncology Center
City
Ivanovo
Country
Russian Federation
Facility Name
Kaluga Regional Oncology Center
City
Kaluga
Country
Russian Federation
Facility Name
Republican Clinical Oncology Center
City
Kazan
Country
Russian Federation
Facility Name
Krasnoyarsk A.I. Kryzhanovsky Regional Oncology Center
City
Krasnoyarsk
Country
Russian Federation
Facility Name
Moscow City Oncology Hospital #62
City
Moscow
Country
Russian Federation
Facility Name
Moscow Clinical Scientific and Practical Center
City
Moscow
Country
Russian Federation
Facility Name
N.N. Blokhin Russian Oncology Research Center, Surgery Dept. 2
City
Moscow
Country
Russian Federation
Facility Name
N.N. Blokhin Russian Oncology Research Center, Surgery Dept. of Female Reproductive System Tumors
City
Moscow
Country
Russian Federation
Facility Name
N.N. Blokhin Russian Oncology Research Center
City
Moscow
Country
Russian Federation
Facility Name
Branch #1 of Nizhny Novgorod Regional Oncology Center
City
Nizhny Novgorod
Country
Russian Federation
Facility Name
City Clinical Hospital #1
City
Novosibirsk
Country
Russian Federation
Facility Name
Novosibirsk Regional Oncology Center
City
Novosibirsk
Country
Russian Federation
Facility Name
Clinical Oncology Center, Dept. of Chemotherapy
City
Omsk
Country
Russian Federation
Facility Name
Clinical Oncology Center
City
Omsk
Country
Russian Federation
Facility Name
Orenburg Regional Clinical Oncology Center
City
Orenburg
Country
Russian Federation
Facility Name
Pyatigorsk Oncology Center
City
Pyatigorsk
Country
Russian Federation
Facility Name
Regional Clinical Oncology Center
City
Ryazan
Country
Russian Federation
Facility Name
Samara Regional Clinical Oncology Center
City
Samara
Country
Russian Federation
Facility Name
City Clinical Oncology Center, Thoracic Oncology Dept.
City
St. Petersburg
Country
Russian Federation
Facility Name
City Clinical Oncology Center, Urology Oncology Dept.
City
St. Petersburg
Country
Russian Federation
Facility Name
City Clinical Oncology Center
City
St. Petersburg
Country
Russian Federation
Facility Name
First I.P. Pavlov State Medical University of St. Petersburg
City
St. Petersburg
Country
Russian Federation
Facility Name
St.Petersburg Municipal Clinical Oncology Center
City
St. Petersburg
Country
Russian Federation
Facility Name
Tambov Regional Oncology Center
City
Tambov
Country
Russian Federation
Facility Name
Tomsk Research Institute of Oncology, General Oncology Dept.
City
Tomsk
Country
Russian Federation
Facility Name
Tomsk Research Institute of Oncology
City
Tomsk
Country
Russian Federation
Facility Name
Republican Clinical Oncology Center
City
Ufa
Country
Russian Federation
Facility Name
Regional Clinical Oncology Center
City
Veliky Novgorod
Country
Russian Federation

12. IPD Sharing Statement

Learn more about this trial

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

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