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Study of Proxinium Plus Best Supportive Care Versus Best Supportive Care for Patients With Advanced Head and Neck Cancer

Primary Purpose

Carcinoma, Squamous Cell of Head and Neck, Carcinoma, Squamous Cell, Neoplasms, Squamous Cell

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Proxinium
Sponsored by
Sesen Bio, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Squamous Cell of Head and Neck

Eligibility Criteria

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

Inclusion Criteria:

Disease Characteristics

  • The patient must be 18 years of age or older.
  • The patient must have squamous cell carcinoma of the head and neck.
  • The squamous cell carcinoma must be Ep-CAM positive.
  • ECOG performance status of 0, 1, 2 or 3.
  • 12 week life expectancy

Prior/Concurrent Therapy

  • The patient must have received therapy for their primary disease (eg, surgery and/or radiotherapy, chemo-radiotherapy or chemotherapy).
  • The patient must have been diagnosed with persistent or recurrent disease or a second primary tumour.
  • The patient's disease must be refractory.
  • There must be at least 2 weeks between the last dose of chemotherapy or radiotherapy and receiving study drug or 4 weeks between the last dose of an experimental drug and receiving study drug.

Patient Characteristics

  • The patient must have adequate hepatic function [alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × upper limit of normal (ULN) and bilirubin level ≤1.5 × ULN].
  • The patient must have adequate renal function (serum creatinine < 1.5 × ULN).
  • The patient must have the following hematological values: granulocytes ≥1500/μL, platelets ≥75 000/μL and hemoglobin >8 g/dL.
  • The patient must have prothrombin time and partial thromboplastin time within normal limits.

Other

• Women of childbearing potential and male patients must agree to use a highly effective contraceptive method.

Exclusion Criteria:

  • The patient has clinically significant distant metastases.
  • The patient is eligible to have surgical resection or radiotherapy, chemo-radiotherapy or chemotherapy.
  • The patient has a nasopharyngeal tumour.
  • The patient has AIDS, hepatitis C or hepatitis B.
  • The patient has clinically significant renal or hepatic disease.
  • Tumors are prone to bleeding.
  • The patient is pregnant or lactating.
  • The patient requires 'blood thinning' medications and can not safely discontinue the medication.
  • The patient is currently enrolled in another clinical trial.

Sites / Locations

  • Hospital Italiano Regional del Sur
  • Hospital Municipal de Agudos Leonidas Lucero
  • Centro de Estudio y Tratamiento de las Enfermedades Neoplasicas (CETEN)
  • Hospital de Clinicas "Jose de San Martin"
  • Hospital Nacional Alejandro Posadas
  • Hospital Universitario Austral
  • Instituto Medico Platense
  • Hospital Italiano Garibaldi
  • Hospital de Câncer de Barretos - Fundação Pio XII
  • Cettro - Centro de Tratamento Oncológico Ltda.
  • Centro Regional Integrado de Oncologia - CRIO
  • Hospital Araújo Jorge
  • Hospital Amaral Carvalho
  • Pro-Onco Centro De Tratamento Oncológico S/C Ltda
  • Biocor - Hospital de Doenças Cardiovasculares Ltda
  • CECAN - Centro do Câncer Francisco Cunha Filho
  • Hospital São Lucas da PUCRS
  • Irmandade Santa Casa de Misericórdia de Porto Alegre
  • Instituto Ribeirãopretano de Combate ao Câncer
  • INCA - Instituto Nacional do Câncer
  • SOS Vida - Soluções em Saúde
  • Santo André Diagnósticos e Tratamentos Ltda
  • Grupo de Pesquisas Médicas
  • Hospital das Clínicas - Faculdade de Medicina da Universidade de São Paulo
  • Hospital Do Câncer A. C. Camargo
  • Clinical Hospital "Sestre milosrdnice"
  • Clinical Hospital Centre Zagreb, Clinic for ENT, Department for Head and Neck Surgery
  • Universtity Hospital for Tumors, Department for Head and Neck Surgery
  • Centre Georges-Francois Leclerc
  • Clinique Guillaume Le Conquerant
  • Centre Régional de Lutte contre le Cancer Val d'Aurelle
  • Charité -Universitätsmedizin Berlin
  • Medizinische Hochschule Hannover
  • Universität Heidelberg
  • Universitätsklinikum Köln
  • Universitätsklinikum Leipzig
  • Universitätsklinikum Schleswig Holstein
  • Johannes Gutenberg-Universität
  • Klinikum der Philipps-Universität Marburg
  • Universitätsklinikum Tübingen
  • Fovarosi Onkormanyzat Uzsoki utcai Korhaza, Fej-nyaksebeszet
  • Orszagos Onkologiai Intezet
  • Debreceni Egyetem OEC, Onkologiai Tanszek
  • Petz Aladar Megyei Korhaz, Ful-orr-gege, Fej, Nyak Sebeszet
  • Department of Medical Oncology, Bangalore Institute of Oncology
  • Kidwai Memorial Institute of Oncology
  • Global Hospitals
  • MNJ Institute of Oncology
  • Nizam's Institute of Medical Sciences
  • Birla Cancer Institute SMS Medical College Hospital
  • SK Soni Hospital
  • Soumya Hospita
  • Amrita Institute of Medical Sciences and Research Centre
  • Netaji Subash Chandra Bose Cancer Research Institute
  • Orchid Nursing Home
  • Department of Medical Oncology Dayanand Medical College & Hospital
  • Asian Institute of Oncology, S L Raheja Hospital
  • Tata Memorial Hospital
  • Department of Medical Oncology AIIMS, Institute Rotary Cancer Hospital
  • Department of Medical Oncology Rajiv Gandhi Cancer Institute and Research Centre
  • Regional Cancer Centre
  • Soroka University Medical Center
  • The Lady Davis Carmel Medical Center
  • Haddasa Ein Carem Hospital
  • Rabin Medical Center
  • Kaplan Medical Center
  • Tel Aviv University Medical School
  • Sheba - Medical Center
  • Azienda Ospedaliera San Gerardo
  • IRCCS Policlinico San Matteo
  • Azienda Ospedaliera Pisana
  • Hospital Clínica del Parque
  • Centro Anticanceroso de la Cruz Roja Mexicana de Mérida
  • OCA Hospital
  • Hospital Central "Dr. Ignacio Morones Prieto"
  • Hospital "Dr. Angel Leaño"
  • Swietokrzyskie Centrum Onkologii
  • Wojewodzki Szpital Specjalistyczny im. L.Rydygiera
  • Wojewodzki Szpital Specjalistyczny im. Mikolaja Kopernika, Regionalny Osrodek Onkologiczny
  • Zaklad Opieki Zdrowotnej MSWiA z Warminsko-Mazurskim Centrum Onkologii
  • Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Opolskie Centrum Onkologii
  • Wielkopolskie Centrum Onkologii
  • Centrum Onkologii Instytut im. M. Sklodowskiej-Curie
  • "Prof. Dr. I. Chiricuta" Institute of Oncology Medical Oncology and Radiotherapy II Department
  • Oradea Clinical County Hospital Department of Medical Oncology
  • Regional Oncology Dispensary
  • Sverdlovsk Regional Oncology Dispensary
  • State Medical Institution Kursk Regional Oncology Dispensary Out-patient department
  • Central Clinical Hospital #2 after MA Semashko OAO "RRW"
  • Moscow Scientific-Research Oncology Institute after P.A. Gertsen
  • SI Russian Oncology Scientific Center after NN Blokhin RAMS
  • PHI OAO RRW Railway Clinical Hospital at station Gorkiy
  • Stavropol Regional Oncology Center, Pyatigorsk branch Out-patient department
  • PHI Dorozhnaya Clinical Hospital at Saratov II Station of Pryvolzhskaya railway OAO Russian Railways
  • SIH Leningrad Regional Oncology Dispansery
  • SPBSIH City Clinical Oncology Dispensary
  • Tambov Regional Oncological Dispensary Surgery Department
  • Republican Clinical Oncological Dispenser Radiological Therapy
  • State Medical Institution Regional Clinical Oncology Dispensary
  • Institute for Oncology and Radiology of Serbia
  • Military Medical Academy (MMA) Clinic for Maxillofacial Surgery
  • Teaching Hospital with Policlinic of F. D. Roosevelt Department of Otorhinolaryngology and Surgery
  • Oncology Institute of St. Elisabeth Clinic of Stomatology and Maxillofacial Surgery
  • Teaching Hospital with Policlinic Bratislava 1st Clinic of Otorhinolaryngology
  • Vychodoslovensky oncologicky ustav a.s.
  • Teaching Hospital with Policlinic Nové Zámky Clinic of Otorhinolaryngology
  • Hospital Santa Creu i Sant Pau
  • Hospital Vall d'Hebron
  • Hospital 12 de Octubre
  • Hospital Ramón y Cajal
  • Hospital Provincial de Pontevedra
  • Hospital Universitario de Salamanca
  • Chernovtsy Regional Oncology Center
  • Kharkov Regional Clinical Oncology Dispensary
  • Institute of Oncology of AMS of Ukraine
  • Institute of Otolaryngology
  • Volyn Regional Oncology Dispensary
  • Uzhgorod National University
  • Zaporozhye Regional Clinical Oncology Dispensary
  • University Hospital Aintree
  • Royal Marsden Hospital
  • Christie Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

1

2

Arm Description

Proxinium plus Best Supportive Care

Best Supportive Care

Outcomes

Primary Outcome Measures

Survival

Secondary Outcome Measures

Tumour response, safety and quality of life

Full Information

First Posted
December 14, 2006
Last Updated
December 22, 2015
Sponsor
Sesen Bio, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00412776
Brief Title
Study of Proxinium Plus Best Supportive Care Versus Best Supportive Care for Patients With Advanced Head and Neck Cancer
Official Title
A Randomized, Multicentre Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of Proxinium Plus Best Supportive Care Versus Best Supportive Care Alone in Patients With Advanced SCCHN Who Have Received at Least One Anti-cancer Treatment Regimen for Advanced Disease
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Terminated
Why Stopped
Corporate reasons unrelated to safety and efficacy
Study Start Date
December 2005 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sesen Bio, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to compare the safety and efficacy of Proxinium plus best supportive care with best supportive care only for patients with squamous cell head and neck cancer.
Detailed Description
Head and neck cancer is a general description of a disease that includes several types of soft tissue carcinomas that develop in the head and neck regions. Proxinium is a recombinant fusion protein that binds to the epithelial cell adhesion molecule (Ep-CAM) that is highly expressed on squamous cell carcinomas of the head and neck (SCCHN). Proxinium is administered via intratumoural injection. The primary objective of the study is to compare the overall survival time for patients treated with intratumourally injected Proxinium plus BSC versus BSC alone. Secondary objectives of the study include comparison of locoregional tumour control, local progression-free survival, symptomatic benefit and safety profile in patients who receive Proxinium plus BSC versus patients who receive BSC

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Squamous Cell of Head and Neck, Carcinoma, Squamous Cell, Neoplasms, Squamous Cell, Head and Neck Neoplasms, Mouth Neoplasms, Head and Neck Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
165 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Proxinium plus Best Supportive Care
Arm Title
2
Arm Type
No Intervention
Arm Description
Best Supportive Care
Intervention Type
Drug
Intervention Name(s)
Proxinium
Intervention Description
700 µg Proxinium, once weekly until complete resolution of all target tumours or radiographic tumour progression
Primary Outcome Measure Information:
Title
Survival
Time Frame
Death or 12 months from the date that the last patient required for efficacy analysis has been randomized
Secondary Outcome Measure Information:
Title
Tumour response, safety and quality of life
Time Frame
Death or 12 months from the date that the last patient required for efficacy analysis has been randomized

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Disease Characteristics The patient must be 18 years of age or older. The patient must have squamous cell carcinoma of the head and neck. The squamous cell carcinoma must be Ep-CAM positive. ECOG performance status of 0, 1, 2 or 3. 12 week life expectancy Prior/Concurrent Therapy The patient must have received therapy for their primary disease (eg, surgery and/or radiotherapy, chemo-radiotherapy or chemotherapy). The patient must have been diagnosed with persistent or recurrent disease or a second primary tumour. The patient's disease must be refractory. There must be at least 2 weeks between the last dose of chemotherapy or radiotherapy and receiving study drug or 4 weeks between the last dose of an experimental drug and receiving study drug. Patient Characteristics The patient must have adequate hepatic function [alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × upper limit of normal (ULN) and bilirubin level ≤1.5 × ULN]. The patient must have adequate renal function (serum creatinine < 1.5 × ULN). The patient must have the following hematological values: granulocytes ≥1500/μL, platelets ≥75 000/μL and hemoglobin >8 g/dL. The patient must have prothrombin time and partial thromboplastin time within normal limits. Other • Women of childbearing potential and male patients must agree to use a highly effective contraceptive method. Exclusion Criteria: The patient has clinically significant distant metastases. The patient is eligible to have surgical resection or radiotherapy, chemo-radiotherapy or chemotherapy. The patient has a nasopharyngeal tumour. The patient has AIDS, hepatitis C or hepatitis B. The patient has clinically significant renal or hepatic disease. Tumors are prone to bleeding. The patient is pregnant or lactating. The patient requires 'blood thinning' medications and can not safely discontinue the medication. The patient is currently enrolled in another clinical trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wendy Cuthbert
Organizational Affiliation
Viventia Biotech Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Hospital Italiano Regional del Sur
City
Bahia Blanca
Country
Argentina
Facility Name
Hospital Municipal de Agudos Leonidas Lucero
City
Bahia Blanca
Country
Argentina
Facility Name
Centro de Estudio y Tratamiento de las Enfermedades Neoplasicas (CETEN)
City
Buenos Aires
Country
Argentina
Facility Name
Hospital de Clinicas "Jose de San Martin"
City
Buenos Aires
Country
Argentina
Facility Name
Hospital Nacional Alejandro Posadas
City
Buenos Aires
Country
Argentina
Facility Name
Hospital Universitario Austral
City
Buenos Aires
Country
Argentina
Facility Name
Instituto Medico Platense
City
La Plata
Country
Argentina
Facility Name
Hospital Italiano Garibaldi
City
Rosario
Country
Argentina
Facility Name
Hospital de Câncer de Barretos - Fundação Pio XII
City
Barretos
Country
Brazil
Facility Name
Cettro - Centro de Tratamento Oncológico Ltda.
City
Brasilia
Country
Brazil
Facility Name
Centro Regional Integrado de Oncologia - CRIO
City
Fortaleza
Country
Brazil
Facility Name
Hospital Araújo Jorge
City
Goiania - GO
Country
Brazil
Facility Name
Hospital Amaral Carvalho
City
Jau
Country
Brazil
Facility Name
Pro-Onco Centro De Tratamento Oncológico S/C Ltda
City
Londrina
Country
Brazil
Facility Name
Biocor - Hospital de Doenças Cardiovasculares Ltda
City
Nova Lima
Country
Brazil
Facility Name
CECAN - Centro do Câncer Francisco Cunha Filho
City
Piracicaba
Country
Brazil
Facility Name
Hospital São Lucas da PUCRS
City
Porto Alegre - RS
Country
Brazil
Facility Name
Irmandade Santa Casa de Misericórdia de Porto Alegre
City
Porto Alegre - RS
Country
Brazil
Facility Name
Instituto Ribeirãopretano de Combate ao Câncer
City
Riberao Preto-SP
Country
Brazil
Facility Name
INCA - Instituto Nacional do Câncer
City
Rio de Janeiro
Country
Brazil
Facility Name
SOS Vida - Soluções em Saúde
City
Salvador - BA
Country
Brazil
Facility Name
Santo André Diagnósticos e Tratamentos Ltda
City
Santo Andre-SP
Country
Brazil
Facility Name
Grupo de Pesquisas Médicas
City
São Paulo - SP
Country
Brazil
Facility Name
Hospital das Clínicas - Faculdade de Medicina da Universidade de São Paulo
City
São Paulo - SP
Country
Brazil
Facility Name
Hospital Do Câncer A. C. Camargo
City
São Paulo
Country
Brazil
Facility Name
Clinical Hospital "Sestre milosrdnice"
City
Zagreb
Country
Croatia
Facility Name
Clinical Hospital Centre Zagreb, Clinic for ENT, Department for Head and Neck Surgery
City
Zagreb
Country
Croatia
Facility Name
Universtity Hospital for Tumors, Department for Head and Neck Surgery
City
Zagreb
Country
Croatia
Facility Name
Centre Georges-Francois Leclerc
City
Dijon
Country
France
Facility Name
Clinique Guillaume Le Conquerant
City
Le Havre
Country
France
Facility Name
Centre Régional de Lutte contre le Cancer Val d'Aurelle
City
Montpellier
Country
France
Facility Name
Charité -Universitätsmedizin Berlin
City
Berlin
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
Country
Germany
Facility Name
Universität Heidelberg
City
Heidelberg
Country
Germany
Facility Name
Universitätsklinikum Köln
City
Köln
Country
Germany
Facility Name
Universitätsklinikum Leipzig
City
Leipzig
Country
Germany
Facility Name
Universitätsklinikum Schleswig Holstein
City
Lübeck
Country
Germany
Facility Name
Johannes Gutenberg-Universität
City
Mainz
Country
Germany
Facility Name
Klinikum der Philipps-Universität Marburg
City
Marburg
Country
Germany
Facility Name
Universitätsklinikum Tübingen
City
Tübingen
Country
Germany
Facility Name
Fovarosi Onkormanyzat Uzsoki utcai Korhaza, Fej-nyaksebeszet
City
Budapest
Country
Hungary
Facility Name
Orszagos Onkologiai Intezet
City
Budapest
Country
Hungary
Facility Name
Debreceni Egyetem OEC, Onkologiai Tanszek
City
Debrecen
Country
Hungary
Facility Name
Petz Aladar Megyei Korhaz, Ful-orr-gege, Fej, Nyak Sebeszet
City
Gyor
Country
Hungary
Facility Name
Department of Medical Oncology, Bangalore Institute of Oncology
City
Bangalore
Country
India
Facility Name
Kidwai Memorial Institute of Oncology
City
Bangalore
Country
India
Facility Name
Global Hospitals
City
Hyderabaad
Country
India
Facility Name
MNJ Institute of Oncology
City
Hyderabaad
Country
India
Facility Name
Nizam's Institute of Medical Sciences
City
Hyderabaad
Country
India
Facility Name
Birla Cancer Institute SMS Medical College Hospital
City
Jaipur
Country
India
Facility Name
SK Soni Hospital
City
Jaipur
Country
India
Facility Name
Soumya Hospita
City
Karkhana
Country
India
Facility Name
Amrita Institute of Medical Sciences and Research Centre
City
Kochin
Country
India
Facility Name
Netaji Subash Chandra Bose Cancer Research Institute
City
Kolkata
Country
India
Facility Name
Orchid Nursing Home
City
Kolkata
Country
India
Facility Name
Department of Medical Oncology Dayanand Medical College & Hospital
City
Ludhiana
Country
India
Facility Name
Asian Institute of Oncology, S L Raheja Hospital
City
Mumbai
Country
India
Facility Name
Tata Memorial Hospital
City
Mumbai
Country
India
Facility Name
Department of Medical Oncology AIIMS, Institute Rotary Cancer Hospital
City
New Delhi
Country
India
Facility Name
Department of Medical Oncology Rajiv Gandhi Cancer Institute and Research Centre
City
New Delhi
Country
India
Facility Name
Regional Cancer Centre
City
Trivandrum
Country
India
Facility Name
Soroka University Medical Center
City
Beer Sheva
Country
Israel
Facility Name
The Lady Davis Carmel Medical Center
City
Haifa
Country
Israel
Facility Name
Haddasa Ein Carem Hospital
City
Jerusalem
Country
Israel
Facility Name
Rabin Medical Center
City
Petach Tikva
Country
Israel
Facility Name
Kaplan Medical Center
City
Rehovot
Country
Israel
Facility Name
Tel Aviv University Medical School
City
Tel Aviv
Country
Israel
Facility Name
Sheba - Medical Center
City
Tel-Hashomer
Country
Israel
Facility Name
Azienda Ospedaliera San Gerardo
City
Monza
Country
Italy
Facility Name
IRCCS Policlinico San Matteo
City
Pavia
Country
Italy
Facility Name
Azienda Ospedaliera Pisana
City
Pisa
Country
Italy
Facility Name
Hospital Clínica del Parque
City
Chihuahua, Chih.
Country
Mexico
Facility Name
Centro Anticanceroso de la Cruz Roja Mexicana de Mérida
City
Merida
Country
Mexico
Facility Name
OCA Hospital
City
Monterrey N.L.
Country
Mexico
Facility Name
Hospital Central "Dr. Ignacio Morones Prieto"
City
San Luis Potosi, SLP
Country
Mexico
Facility Name
Hospital "Dr. Angel Leaño"
City
Zapopan, Jalisco
Country
Mexico
Facility Name
Swietokrzyskie Centrum Onkologii
City
Kielce
Country
Poland
Facility Name
Wojewodzki Szpital Specjalistyczny im. L.Rydygiera
City
Krakow
Country
Poland
Facility Name
Wojewodzki Szpital Specjalistyczny im. Mikolaja Kopernika, Regionalny Osrodek Onkologiczny
City
Lodz
Country
Poland
Facility Name
Zaklad Opieki Zdrowotnej MSWiA z Warminsko-Mazurskim Centrum Onkologii
City
Olsztyn
Country
Poland
Facility Name
Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Opolskie Centrum Onkologii
City
Opole
Country
Poland
Facility Name
Wielkopolskie Centrum Onkologii
City
Poznan
Country
Poland
Facility Name
Centrum Onkologii Instytut im. M. Sklodowskiej-Curie
City
Warszawa
Country
Poland
Facility Name
"Prof. Dr. I. Chiricuta" Institute of Oncology Medical Oncology and Radiotherapy II Department
City
Cluj-Napoca
Country
Romania
Facility Name
Oradea Clinical County Hospital Department of Medical Oncology
City
Oradea
Country
Romania
Facility Name
Regional Oncology Dispensary
City
Astrakhan
Country
Russian Federation
Facility Name
Sverdlovsk Regional Oncology Dispensary
City
Ekaterinburg
Country
Russian Federation
Facility Name
State Medical Institution Kursk Regional Oncology Dispensary Out-patient department
City
Kursk
Country
Russian Federation
Facility Name
Central Clinical Hospital #2 after MA Semashko OAO "RRW"
City
Moscow
Country
Russian Federation
Facility Name
Moscow Scientific-Research Oncology Institute after P.A. Gertsen
City
Moscow
Country
Russian Federation
Facility Name
SI Russian Oncology Scientific Center after NN Blokhin RAMS
City
Moscow
Country
Russian Federation
Facility Name
PHI OAO RRW Railway Clinical Hospital at station Gorkiy
City
Nizhniy Novgorod
Country
Russian Federation
Facility Name
Stavropol Regional Oncology Center, Pyatigorsk branch Out-patient department
City
Pyatigorsk
Country
Russian Federation
Facility Name
PHI Dorozhnaya Clinical Hospital at Saratov II Station of Pryvolzhskaya railway OAO Russian Railways
City
Saratov
Country
Russian Federation
Facility Name
SIH Leningrad Regional Oncology Dispansery
City
St. Petersburg
Country
Russian Federation
Facility Name
SPBSIH City Clinical Oncology Dispensary
City
St. Petersburg
Country
Russian Federation
Facility Name
Tambov Regional Oncological Dispensary Surgery Department
City
Tambov
Country
Russian Federation
Facility Name
Republican Clinical Oncological Dispenser Radiological Therapy
City
Ufa
Country
Russian Federation
Facility Name
State Medical Institution Regional Clinical Oncology Dispensary
City
Ulyanovsk
Country
Russian Federation
Facility Name
Institute for Oncology and Radiology of Serbia
City
Belgrade
Country
Serbia
Facility Name
Military Medical Academy (MMA) Clinic for Maxillofacial Surgery
City
Belgrade
Country
Serbia
Facility Name
Teaching Hospital with Policlinic of F. D. Roosevelt Department of Otorhinolaryngology and Surgery
City
Banská Bystrica
Country
Slovakia
Facility Name
Oncology Institute of St. Elisabeth Clinic of Stomatology and Maxillofacial Surgery
City
Bratislava
Country
Slovakia
Facility Name
Teaching Hospital with Policlinic Bratislava 1st Clinic of Otorhinolaryngology
City
Bratislava
Country
Slovakia
Facility Name
Vychodoslovensky oncologicky ustav a.s.
City
Kosice
Country
Slovakia
Facility Name
Teaching Hospital with Policlinic Nové Zámky Clinic of Otorhinolaryngology
City
Nove Zamky
Country
Slovakia
Facility Name
Hospital Santa Creu i Sant Pau
City
Barcelona
Country
Spain
Facility Name
Hospital Vall d'Hebron
City
Barcelona
Country
Spain
Facility Name
Hospital 12 de Octubre
City
Madrid
Country
Spain
Facility Name
Hospital Ramón y Cajal
City
Madrid
Country
Spain
Facility Name
Hospital Provincial de Pontevedra
City
Pontevedra
Country
Spain
Facility Name
Hospital Universitario de Salamanca
City
Salamanca, Castilla y León
Country
Spain
Facility Name
Chernovtsy Regional Oncology Center
City
Chernivtsy
Country
Ukraine
Facility Name
Kharkov Regional Clinical Oncology Dispensary
City
Kharkov
Country
Ukraine
Facility Name
Institute of Oncology of AMS of Ukraine
City
Kiev
Country
Ukraine
Facility Name
Institute of Otolaryngology
City
Kiev
Country
Ukraine
Facility Name
Volyn Regional Oncology Dispensary
City
Lutsk
Country
Ukraine
Facility Name
Uzhgorod National University
City
Uzhorod
Country
Ukraine
Facility Name
Zaporozhye Regional Clinical Oncology Dispensary
City
Zaporozhye
Country
Ukraine
Facility Name
University Hospital Aintree
City
Liverpool
Country
United Kingdom
Facility Name
Royal Marsden Hospital
City
London
Country
United Kingdom
Facility Name
Christie Hospital
City
Manchester
Country
United Kingdom

12. IPD Sharing Statement

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Study of Proxinium Plus Best Supportive Care Versus Best Supportive Care for Patients With Advanced Head and Neck Cancer

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