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An Efficacy and Safety Study of Oral and Intravenous Palonosetron 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
Oral palonosetron
I.V. 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:

  • Naïve to cytotoxic chemotherapy. Previous biological or hormonal therapy is permitted.
  • Diagnosed with a malignant solid tumor and scheduled to receive first course of cytotoxic chemotherapy with cisplatin administered as a single I.V. dose of equal or more than 70 mg/m2 over 1-4 hours on study Day 1, either alone or in combination with other chemotherapeutic agents.
  • If scheduled to receive combination regimens, non-cisplatin agents of moderate to high emetogenic potential are allowed and they must be administered following the cisplatin infusion and completed no more than 6 hours after the initiation of cisplatin infusion.
  • If scheduled to receive chemotherapy agents of minimal to low emetogenic potential, they are to be given on Day 1 following cisplatin or on any subsequent study day.
  • ECOG Performance Status of 0, 1, or 2
  • Female patients of either non-childbearing potential or child-bearing potential with a commitment to use contraceptive methods throughout the clinical trial
  • Hematologic and metabolic status adequate for receiving a highly emetogenic cisplatin-based regimen based on laboratory criteria (Neutrophils,Platelets, Bilirubin, Liver enzymes, Serum Creatinine or Creatinine Clearance)
  • If a patient has a known hepatic or renal impairment, he/she may be enrolled in this study at the discretion of the Investigator.
  • If a patient has a known history or predisposition to cardiac conduction interval abnormalities he/she may be enrolled in this study at the discretion of the Investigator.

Exclusion Criteria:

  • If female, pregnant or lactating.
  • Current use of illicit drugs or current evidence of alcohol abuse.
  • Scheduled to receive moderately emetogenic chemotherapy (MEC) or HEC from Day 2 to Day 5 following cisplatin administration.
  • Received or is scheduled to receive radiation therapy to the abdomen, or the pelvis within 1 week prior to Day 1 or between Days 1 to 5.
  • Any vomiting, retching, or mild nausea within 24 hours prior to Day 1.
  • Symptomatic primary or metastatic CNS malignancy.
  • Active peptic ulcer disease, gastrointestinal obstruction, increased intracranial pressure, hypercalcemia, an active infection or any uncontrolled 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, CINV) or pose unwarranted risks in administering the study drugs to the patient.
  • Known hypersensitivity or contraindication to 5-HT3 receptor antagonists (e.g., palonosetron, ondansetron, granisetron, dolasetron, tropisetron, ramosetron) or dexamethasone.
  • Participation in a 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 study.
  • Systemic corticosteroid therapy at any dose within 72 hours prior to Day 1. However topical and inhaled corticosteroids with a steroid dose of £ 10 mg of prednisone daily or its equivalent 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 Day 1

Sites / Locations

  • Genesis Cancer Centre
  • Compassionate Cancer Center
  • Compassionate Cancer Centre Medical Group
  • Facey Medical Group
  • Compassionate Cancer Care Medical Group
  • Signal Point Clinical Research Center, LLC
  • Wellmont Medical Associates-Oncology and Hematology
  • Charleston Hematology Oncology
  • Northern Utah Associates [Hematology/ Oncology]
  • Centro Oncológico Integral (COI)
  • Instituto Oncológico de Córdoba (IONC)
  • Clínica Universitaria Reina Fabiola
  • Instituto Médico CER [Oncology]
  • Sanatorio Parque
  • Centro Medico San Roque
  • ISIS Clinica Especializada
  • MHAT Dr. Tota Venkova
  • Specialized Hospital for Active Treatement of Oncology Diseases - Sofia District Medical Oncology Department
  • UMHAT "Tsaritsa Yoanna - ISUL" Ltd.Medical Oncology Clinic
  • Specialised Hospital for Active treatment on Oncology
  • District Dispensery for Oncology Diseases with in-patient
  • Complex Oncology Centre
  • Klinicki bolnicki centar [Oncology]
  • KBC Rijeka
  • Opca bolnica Varazdin
  • KBC Zagreb
  • Klinicka bolnica [Sestre milosrdnice]
  • Klinik und Poliklinik für Onkologie und Hämatologie Universitätsmedizin Charité Mitte
  • OncoResearch Lerchenfeld UG
  • Städtisches Klinikum München
  • Staedtisches Krankenhaus Muenchen Neuperlach
  • Semmelweis Egyetem Kútvölgyi Klinikai Tömb
  • Fővárosi Önkormányzat Uzsoki utcai Kórház
  • Petz Aladár Megyei Oktató Kórház
  • Bács-Kiskun Megyei Önkormányzat Kórháza, Szeged
  • Pécsi Tudományegyetem [Onkoterápiás Intézet]
  • Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz
  • Yashoda Super speciality Hospital
  • Sujan Surgical Cancer Hospital and Amracvati Cancer Foundation
  • Apollo Speciality Hospital
  • Sri Venkateshwara Hospital [Medical Oncology]
  • Chinmaya Mission Hospital
  • City Cancer Centre [Surgical and Medical Oncology]
  • Fondazione Poliambulanza Istituto Ospedaliero
  • Ospedale Vito Fazzi - ASL Lecce
  • Presidio Ospedaliero "Alessandro Manzoni"
  • AO Regionale S.Carlo di Potenza
  • Szpital Wojewodzki Zespolony
  • Wojewodzki Szpital Specjalistyczny im. M.Kopernika
  • Szpital Wojewodzki w Lomzy im. Kardynala S. Wyszynskiego
  • Wojewodzki Szpital Specjalistyczny im. J. Korczaka
  • Centrum Onkologii - Instytut im. Marii Sklodowskiej - Curie
  • NZOZ Magodent - Centrum Medczyne Ostrobramska
  • Spitalul Judetean de Urgenta "Dr. Constantin Opris"
  • Institutul Oncologic "Prof. Dr. Alex. Trestioreanu"
  • Institutul Oncologic "Prof. Dr. Ion Chiricuta"
  • Spitalul Clinic Judetean de Urgenta Cluj (Oncologie Medicala)
  • Centrul de Oncologie Euroclinic
  • Institutul Regional de Oncologie Iasi
  • Spitalul Clinic Judetean de Urgenta Sibiu [Oncologie]
  • Oncomed SRL
  • GUZ Arkhangelsk Regional Clinical Oncological Dispensary
  • GOU VPO Krasnoyarsk State Medical University n.a. prof. V.F.
  • GUZ Lipetsk Regional Oncology Dispensary [General Oncology]
  • GUZ Regional Oncology Dispensary #2
  • RAMN - Russian Cancer Research Center
  • Russian Oncology Research Center n.a. N.N. Blokhin RAMN
  • MBUZ City Clinical Hospital #1 [Oncology]
  • FGBU "Medical Radiology Scientific Center of Minzdravsotsrazvitiya RF
  • Ryazan State Med. Univer. n.a. I.I.Pavlov based Ryazan Regio
  • GUZ Leningrad Regional Oncological Dispensary
  • St. Petersburg Clinical Oncology Dispesary
  • Komunalnyi likuvalno-profilaktychnyi zaklad "Chernigivskyi
  • Komunalnyi zaklad Miska bahatoprofilna klinichna likarnia #4
  • Komunalno-klinichnyi likuvalno-profilaktychnyi zaklad
  • DU IMR AMNU [vd khemter]
  • Kharkivskyi oblasnyi onkologichnyi klinichnyi tsentr
  • Chmelnytskyi Regional Clinical Oncology Centre [Oncology]
  • Uzhgorod National University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Oral palonosteron plus dexamethasone

I.V. palonosetron plus dexamethasone

Arm Description

Oral palonosetron (Aloxi 0.50 mg softgel capsule) 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) 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

Secondary Outcome Measures

Percentage of Patients With no Emesis
Percentage of Patients With no Rescue Medication

Full Information

First Posted
May 30, 2011
Last Updated
August 30, 2021
Sponsor
Helsinn Healthcare SA
Collaborators
Parexel
search

1. Study Identification

Unique Protocol Identification Number
NCT01363479
Brief Title
An Efficacy and Safety Study of Oral and Intravenous Palonosetron for the Prevention of Nausea and Vomiting
Official Title
Single-dose, Multicenter, Randomized, Double-blind, Double-dummy, Parallel Group Study to Assess the Efficacy and Safety of Oral Palonosetron 0.50 mg Compared to I.V. Palonosetron 0.25 mg Administered With Dexamethasone for the Prevention of Chemotherapy-induced Nausea and Vomiting in Cancer Patients Receiving Highly Emetogenic Cisplatin-based Chemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
PALO-10-01 is a clinical study assessing efficacy and safety of a single oral dose of palonosetron compared to a single intravenous dose of palonosetron (Aloxi, an antiemetic drug), both given with oral dexamethasone. The objective of the study is to demonstrate that oral palonosetron 0.50 mg is as effective as (non-inferior to) 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
743 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oral palonosteron plus dexamethasone
Arm Type
Experimental
Arm Description
Oral palonosetron (Aloxi 0.50 mg softgel capsule) 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 plus dexamethasone
Arm Type
Active Comparator
Arm Description
Intravenous palonosetron (Aloxi 0.25 mg solution for injection) 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)
Oral palonosetron
Intervention Type
Drug
Intervention Name(s)
I.V. 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
Time Frame
0-24 hours
Secondary Outcome Measure Information:
Title
Percentage of Patients With no Emesis
Time Frame
0-24 hours
Title
Percentage of Patients With no Rescue Medication
Time Frame
0-24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Naïve to cytotoxic chemotherapy. Previous biological or hormonal therapy is permitted. Diagnosed with a malignant solid tumor and scheduled to receive first course of cytotoxic chemotherapy with cisplatin administered as a single I.V. dose of equal or more than 70 mg/m2 over 1-4 hours on study Day 1, either alone or in combination with other chemotherapeutic agents. If scheduled to receive combination regimens, non-cisplatin agents of moderate to high emetogenic potential are allowed and they must be administered following the cisplatin infusion and completed no more than 6 hours after the initiation of cisplatin infusion. If scheduled to receive chemotherapy agents of minimal to low emetogenic potential, they are to be given on Day 1 following cisplatin or on any subsequent study day. ECOG Performance Status of 0, 1, or 2 Female patients of either non-childbearing potential or child-bearing potential with a commitment to use contraceptive methods throughout the clinical trial Hematologic and metabolic status adequate for receiving a highly emetogenic cisplatin-based regimen based on laboratory criteria (Neutrophils,Platelets, Bilirubin, Liver enzymes, Serum Creatinine or Creatinine Clearance) If a patient has a known hepatic or renal impairment, he/she may be enrolled in this study at the discretion of the Investigator. If a patient has a known history or predisposition to cardiac conduction interval abnormalities he/she may be enrolled in this study at the discretion of the Investigator. Exclusion Criteria: If female, pregnant or lactating. Current use of illicit drugs or current evidence of alcohol abuse. Scheduled to receive moderately emetogenic chemotherapy (MEC) or HEC from Day 2 to Day 5 following cisplatin administration. Received or is scheduled to receive radiation therapy to the abdomen, or the pelvis within 1 week prior to Day 1 or between Days 1 to 5. Any vomiting, retching, or mild nausea within 24 hours prior to Day 1. Symptomatic primary or metastatic CNS malignancy. Active peptic ulcer disease, gastrointestinal obstruction, increased intracranial pressure, hypercalcemia, an active infection or any uncontrolled 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, CINV) or pose unwarranted risks in administering the study drugs to the patient. Known hypersensitivity or contraindication to 5-HT3 receptor antagonists (e.g., palonosetron, ondansetron, granisetron, dolasetron, tropisetron, ramosetron) or dexamethasone. Participation in a 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 study. Systemic corticosteroid therapy at any dose within 72 hours prior to Day 1. However topical and inhaled corticosteroids with a steroid dose of £ 10 mg of prednisone daily or its equivalent 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 Day 1
Facility Information:
Facility Name
Genesis Cancer Centre
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
Country
United States
Facility Name
Compassionate Cancer Center
City
Corona
State/Province
California
ZIP/Postal Code
92879
Country
United States
Facility Name
Compassionate Cancer Centre Medical Group
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
Facey Medical Group
City
Mission Hills
State/Province
California
ZIP/Postal Code
91345
Country
United States
Facility Name
Compassionate Cancer Care Medical Group
City
Riverside
State/Province
California
ZIP/Postal Code
92501
Country
United States
Facility Name
Signal Point Clinical Research Center, LLC
City
Middletown
State/Province
Ohio
ZIP/Postal Code
45042
Country
United States
Facility Name
Wellmont Medical Associates-Oncology and Hematology
City
Bristol
State/Province
Rhode Island
ZIP/Postal Code
37620
Country
United States
Facility Name
Charleston Hematology Oncology
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
Facility Name
Northern Utah Associates [Hematology/ Oncology]
City
Ogden
State/Province
Utah
ZIP/Postal Code
84403
Country
United States
Facility Name
Centro Oncológico Integral (COI)
City
Mar del Plata
State/Province
Buenos Aires
ZIP/Postal Code
7600
Country
Argentina
Facility Name
Instituto Oncológico de Córdoba (IONC)
City
Cordoba
ZIP/Postal Code
X5006HBF
Country
Argentina
Facility Name
Clínica Universitaria Reina Fabiola
City
Córdoba
ZIP/Postal Code
X5004FHP
Country
Argentina
Facility Name
Instituto Médico CER [Oncology]
City
Quilmes
ZIP/Postal Code
B1878DVB
Country
Argentina
Facility Name
Sanatorio Parque
City
Rosario
ZIP/Postal Code
2000
Country
Argentina
Facility Name
Centro Medico San Roque
City
San Miguel de Tucuman
ZIP/Postal Code
T4000AIK
Country
Argentina
Facility Name
ISIS Clinica Especializada
City
Santa Fe
ZIP/Postal Code
3000
Country
Argentina
Facility Name
MHAT Dr. Tota Venkova
City
Gabrovo
ZIP/Postal Code
5300
Country
Bulgaria
Facility Name
Specialized Hospital for Active Treatement of Oncology Diseases - Sofia District Medical Oncology Department
City
Sofia
ZIP/Postal Code
1233
Country
Bulgaria
Facility Name
UMHAT "Tsaritsa Yoanna - ISUL" Ltd.Medical Oncology Clinic
City
Sofia
ZIP/Postal Code
1572
Country
Bulgaria
Facility Name
Specialised Hospital for Active treatment on Oncology
City
Sofia
ZIP/Postal Code
1756
Country
Bulgaria
Facility Name
District Dispensery for Oncology Diseases with in-patient
City
Sofia
ZIP/Postal Code
6300
Country
Bulgaria
Facility Name
Complex Oncology Centre
City
Stara Zagora
ZIP/Postal Code
6003
Country
Bulgaria
Facility Name
Klinicki bolnicki centar [Oncology]
City
Osijek
ZIP/Postal Code
31000
Country
Croatia
Facility Name
KBC Rijeka
City
Rijeka
ZIP/Postal Code
51000
Country
Croatia
Facility Name
Opca bolnica Varazdin
City
Varazdin
ZIP/Postal Code
42000
Country
Croatia
Facility Name
KBC Zagreb
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Klinicka bolnica [Sestre milosrdnice]
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Klinik und Poliklinik für Onkologie und Hämatologie Universitätsmedizin Charité Mitte
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
OncoResearch Lerchenfeld UG
City
Hamburg
ZIP/Postal Code
22081
Country
Germany
Facility Name
Städtisches Klinikum München
City
München
ZIP/Postal Code
81545
Country
Germany
Facility Name
Staedtisches Krankenhaus Muenchen Neuperlach
City
München
ZIP/Postal Code
81737
Country
Germany
Facility Name
Semmelweis Egyetem Kútvölgyi Klinikai Tömb
City
Budapest
ZIP/Postal Code
1125
Country
Hungary
Facility Name
Fővárosi Önkormányzat Uzsoki utcai Kórház
City
Budapest
ZIP/Postal Code
1145
Country
Hungary
Facility Name
Petz Aladár Megyei Oktató Kórház
City
Györ
ZIP/Postal Code
9024
Country
Hungary
Facility Name
Bács-Kiskun Megyei Önkormányzat Kórháza, Szeged
City
Kecskemet
ZIP/Postal Code
6000
Country
Hungary
Facility Name
Pécsi Tudományegyetem [Onkoterápiás Intézet]
City
Pécs
ZIP/Postal Code
7624
Country
Hungary
Facility Name
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz
City
Szolnok
ZIP/Postal Code
5004
Country
Hungary
Facility Name
Yashoda Super speciality Hospital
City
Hyderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
500 082
Country
India
Facility Name
Sujan Surgical Cancer Hospital and Amracvati Cancer Foundation
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
444605
Country
India
Facility Name
Apollo Speciality Hospital
City
Chennai
State/Province
Tamil Nadu
ZIP/Postal Code
600035
Country
India
Facility Name
Sri Venkateshwara Hospital [Medical Oncology]
City
Bangalore
ZIP/Postal Code
560068
Country
India
Facility Name
Chinmaya Mission Hospital
City
Bangalore
ZIP/Postal Code
632004
Country
India
Facility Name
City Cancer Centre [Surgical and Medical Oncology]
City
Vijayawada
ZIP/Postal Code
520002
Country
India
Facility Name
Fondazione Poliambulanza Istituto Ospedaliero
City
Brescia
ZIP/Postal Code
25124
Country
Italy
Facility Name
Ospedale Vito Fazzi - ASL Lecce
City
Lecce
ZIP/Postal Code
73100
Country
Italy
Facility Name
Presidio Ospedaliero "Alessandro Manzoni"
City
Lecco
ZIP/Postal Code
23900
Country
Italy
Facility Name
AO Regionale S.Carlo di Potenza
City
Potenza
ZIP/Postal Code
85100
Country
Italy
Facility Name
Szpital Wojewodzki Zespolony
City
Elblag
ZIP/Postal Code
82-300
Country
Poland
Facility Name
Wojewodzki Szpital Specjalistyczny im. M.Kopernika
City
Lodz
ZIP/Postal Code
93-509
Country
Poland
Facility Name
Szpital Wojewodzki w Lomzy im. Kardynala S. Wyszynskiego
City
Lomza
ZIP/Postal Code
18-400
Country
Poland
Facility Name
Wojewodzki Szpital Specjalistyczny im. J. Korczaka
City
Slupsk
ZIP/Postal Code
76-200
Country
Poland
Facility Name
Centrum Onkologii - Instytut im. Marii Sklodowskiej - Curie
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
NZOZ Magodent - Centrum Medczyne Ostrobramska
City
Warszawa
ZIP/Postal Code
04-125
Country
Poland
Facility Name
Spitalul Judetean de Urgenta "Dr. Constantin Opris"
City
Baia-Mare
ZIP/Postal Code
430031
Country
Romania
Facility Name
Institutul Oncologic "Prof. Dr. Alex. Trestioreanu"
City
Bucharest
ZIP/Postal Code
22328
Country
Romania
Facility Name
Institutul Oncologic "Prof. Dr. Ion Chiricuta"
City
Cluj-Napoca
ZIP/Postal Code
400015
Country
Romania
Facility Name
Spitalul Clinic Judetean de Urgenta Cluj (Oncologie Medicala)
City
Cluj-Napoca
ZIP/Postal Code
400349
Country
Romania
Facility Name
Centrul de Oncologie Euroclinic
City
Iasi
ZIP/Postal Code
700106
Country
Romania
Facility Name
Institutul Regional de Oncologie Iasi
City
Iasi
ZIP/Postal Code
700483
Country
Romania
Facility Name
Spitalul Clinic Judetean de Urgenta Sibiu [Oncologie]
City
Sibiu
ZIP/Postal Code
550245
Country
Romania
Facility Name
Oncomed SRL
City
Timisoara
ZIP/Postal Code
300239
Country
Romania
Facility Name
GUZ Arkhangelsk Regional Clinical Oncological Dispensary
City
Arkhangelsk
ZIP/Postal Code
163045
Country
Russian Federation
Facility Name
GOU VPO Krasnoyarsk State Medical University n.a. prof. V.F.
City
Krasnoyarsk
ZIP/Postal Code
660022
Country
Russian Federation
Facility Name
GUZ Lipetsk Regional Oncology Dispensary [General Oncology]
City
Lipetsk
ZIP/Postal Code
398005
Country
Russian Federation
Facility Name
GUZ Regional Oncology Dispensary #2
City
Magnitogorsk
ZIP/Postal Code
455001
Country
Russian Federation
Facility Name
RAMN - Russian Cancer Research Center
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Russian Oncology Research Center n.a. N.N. Blokhin RAMN
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
MBUZ City Clinical Hospital #1 [Oncology]
City
Novosibirsk
ZIP/Postal Code
630047
Country
Russian Federation
Facility Name
FGBU "Medical Radiology Scientific Center of Minzdravsotsrazvitiya RF
City
Obninsk
ZIP/Postal Code
249036
Country
Russian Federation
Facility Name
Ryazan State Med. Univer. n.a. I.I.Pavlov based Ryazan Regio
City
Ryazan
ZIP/Postal Code
390026
Country
Russian Federation
Facility Name
GUZ Leningrad Regional Oncological Dispensary
City
Saint Petersburg
ZIP/Postal Code
188663
Country
Russian Federation
Facility Name
St. Petersburg Clinical Oncology Dispesary
City
Saint Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
Komunalnyi likuvalno-profilaktychnyi zaklad "Chernigivskyi
City
Chernihiv
ZIP/Postal Code
14029
Country
Ukraine
Facility Name
Komunalnyi zaklad Miska bahatoprofilna klinichna likarnia #4
City
Dnipropetrovsk
ZIP/Postal Code
49102
Country
Ukraine
Facility Name
Komunalno-klinichnyi likuvalno-profilaktychnyi zaklad
City
Donetsk
ZIP/Postal Code
83092
Country
Ukraine
Facility Name
DU IMR AMNU [vd khemter]
City
Kharkiv
ZIP/Postal Code
61024
Country
Ukraine
Facility Name
Kharkivskyi oblasnyi onkologichnyi klinichnyi tsentr
City
Kharkiv
ZIP/Postal Code
61070
Country
Ukraine
Facility Name
Chmelnytskyi Regional Clinical Oncology Centre [Oncology]
City
Khmelnytskyi
ZIP/Postal Code
29009
Country
Ukraine
Facility Name
Uzhgorod National University
City
Uzhgorod
ZIP/Postal Code
88000
Country
Ukraine

12. IPD Sharing Statement

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An Efficacy and Safety Study of Oral and Intravenous Palonosetron for the Prevention of Nausea and Vomiting

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