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Study of the Efficacy and Safety of Glufosfamide Compared With Best Supportive Care in Metastatic Pancreatic Cancer

Primary Purpose

Pancreatic Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Glufosfamide
Sponsored by
Threshold Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring Pancreas, Cancer, Pancreatic Adenocarcinoma, Metastatic, Glufosfamide

Eligibility Criteria

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

Inclusion Criteria: At least 18 years of age Pancreatic adenocarcinoma proven either by histology (surgical biopsy) or cytology (CT- or endoscopic-guided) Metastatic pancreatic cancer Disease progression during or after treatment with gemcitabine (alone or in combination with other agents; at regular, not radiosensitizing, doses) for advanced/metastatic pancreatic cancer Measurable or nonmeasurable disease by RECIST criteria (at least one target or nontarget lesion) Recovered from reversible toxicities of prior therapy Karnofsky performance status ≥70 All women of childbearing potential and all men must agree to use effective means of contraception (surgical sterilization or the use of barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel or an IUD) from entry into the study through 6 months after the last dose Ability to understand the purposes and risks of the study and has signed a written informed consent form approved by the investigator's IRB/Ethics Committee Exclusion Criteria: More than one prior systemic therapy regimen for metastatic/locally advanced pancreatic cancer (radiosensitizing doses of 5FU or gemcitabine at the time of initial radiotherapy do not count as a prior systemic therapy regimen) Hormonal therapy, radiation therapy, biologic therapy, chemotherapy or other systemic antitumor therapy for pancreatic cancer within 14 days prior to study start Symptomatic brain metastases (baseline CT scan is not required in asymptomatic subjects) Active clinically significant infection requiring antibiotics Known HIV positive or active hepatitis B or C Recent (one year) history or symptoms of cardiovascular disease (NYHA Class 2, 3, or 4), particularly coronary artery disease, arrhythmias or conduction defects with risk of cardiovascular instability, uncontrolled hypertension, clinically significant pericardial effusion, or congestive heart failure No other active malignancies (other than treated non-melanoma skin cancer or treated in situ cancer) within the past year Major surgery within 3 weeks of the start of study treatment, without complete recovery Clinically significant abnormalities in laboratory test results (including complete blood count, chemistry panel including electrolytes, and urinalysis) (Hemoglobin <9 g/dL (may receive transfusion or erythropoietin to maintain))

Sites / Locations

  • Augusta Oncology Associates
  • Kenmar Research Institute
  • Mile High Oncology
  • Northwestern Connecticut Oncology - Hematology Associates
  • Palm Beach Institute of Hematology and Oncology
  • Hematology/Oncology of the North Shore
  • Fort Wayne Medical Oncology/Hem
  • Norton Healthcare Center
  • West Michigan Cancer Center
  • Hattiesburg Clinic Oncology
  • Columbia Comprehensive Cancer Care Clinic
  • Bond Clinic
  • Deaconess Billings Clinic
  • Office of Clinical Trials
  • New Mexico Oncology Hematology Consultants
  • Hanover Medical Specialists
  • Vita Hematology Oncology PC
  • The Family Cancer Center , PLLC
  • Center for Oncology Research and Treatment
  • JPS Center for Cancer Care
  • Northern Utah Associates
  • Cancer Outreach Association
  • Marshfield Clinic Research Foundation
  • Hospital Interzonal General de Agudos
  • Hospital Posadas
  • Policlinica Privada Instituto de Medicina Nuclear
  • Hospital Udaondo
  • Hospital Alvarez
  • Hospital Churruca - Visca
  • Instituto Medico Alexander Fleming
  • Instituto CAICI
  • Fundacao Pio XII - Hospital de Cancer de Barretos
  • Fundação Pio XII - Hospital de Câncer de Barretos
  • Hospital Vera Cruz - Clinica de Oncologia
  • Hospital Luxemburgo
  • Hospital de Clínicas da UFPR
  • Associacao de Combate ao Cancer em Goias, Hospital Araujo Jorge, Setor de Oncologia Clinica
  • Hospital Nossa Senhora da Conceicao
  • Instituto Nacional do Cancer - INCA
  • Clinica de Oncologia Medica S/C Ltda
  • Hospital do Cancer - AC Camargo
  • Grupo Paulista Oncologia Integrada
  • Department of Chemotherapy Dr. Georgi Stranski General Hospital of Pleven University
  • First Internal Department Plovdiv Regional Oncology Center with In-patient Department
  • Department of Chemotherapy Sofia Regional Oncology Center
  • Chemotherapy Clinic Queen Joanna General Hospital
  • Haematology and Oncology Clinic Military Medical Academy
  • Chemotherapy Clinic Specialized Oncology Hospital
  • Department of Chemotherapy Veliko Tarnovo Regional Oncology Center
  • Department of Medicinal Oncotherapy and Palliative Care Dr. Marko Markov Regional Oncology Center
  • Fakultni nemocnice Brno Oddeleni Klinicke Onkologie
  • Masarykuv onkologicky Ustav
  • Krajska nemocnice Pardubice,oddeleni Radiacni Onkologie
  • Onkologicka Klinika, Fakultni nemocnice Olomouc
  • Onkologicke Oddeleni, Batova krajska nemocnice Zlin
  • National Institute of Oncology
  • Szent Imre Korhaz Onkologia
  • Szent László Kórház, Onkológia
  • Vaszary Kolos Korhaz
  • Petz Aladar County Hospital, Department of Oncology
  • Baranya megyei Korhaz Onkologial osztaly
  • Bangalore Institute of Oncology
  • Curie Centre of Oncology
  • Radhakrishan Birla Cancer Centre
  • Jaslok Hospital and Research Centre
  • Sir Ganga Ram Hospital
  • Hospital Universitario "Dr. Angel Leano"
  • Hospital y Clinica OCA S.A. De C.V.
  • Hospital Central "Dr. Ignacio Morones Prieto" Departamento de Radioterapia.
  • Hospital regional ISSSTE "Merida"
  • Centro Estatal de Cancerologia
  • Hospital Clinica del Parque
  • Centro Medico ISSEMYM
  • Hospital general "5 de Diciembre" ISSSTE
  • Hospital Regional de Especialidades No. 30 IMSS
  • Hospital de Oncologia Centro Medico
  • Instituto Nacional de Ciencias Medicas u Nutricion "Salvador Zubiran"
  • Fundeni Clinical Institute
  • Trestioreanu Institute of Oncology
  • "I. Chiricuta" Institute of Oncology
  • Craiova Emergency Clinical County Hospital
  • Timisoara City Hospital
  • Institute of Medical Radiology, Russian Academy of Medical Science
  • Cheliabinsk Regional Oncology Center
  • Irkutsk Regional Oncology Center
  • Clinical Oncology Center
  • Krasnodar City Oncology Center
  • Blokhin Cancer Research Center, Dept of Clinical Pharmacology and Chemotherapy
  • Central Clinical Hospital of the presidentof the Russian Federation
  • Hertzen Research Institute of Oncology
  • Central Clinical Hospital of the Ministru of Transport n.a. Semashko
  • Orenburg, Regional Oncology Center
  • Samara Oncology Center
  • St. Petersburg, Central Research Institute of Radiology
  • Medical Academy of Postgraduate Education
  • St. Petersburg Oncology Center
  • Mechnikov State Medical Academy
  • Voronezh Regional Clinical Oncology Center
  • Yaroslavl Regional Oncology Center
  • Dnepropetrovsk City Clinical Hospital
  • Donetsk Regional Antitumor Center
  • State Communal Healthcare Institution: Kharkov Regional Clinical Oncological Center
  • Institute of Oncology under the Academy of Medical Sciences of Ukraine
  • Kiev Municipal Clinical Hospital #10, Kiev Center for Biliary, Biliary tracts and Pancreas Surgery
  • Krivoy Rog City Oncology Center
  • Lugansk Regional Clinical Oncological Center
  • Nikolaev Regional Oncology Centre
  • Odessa Regional Clinical Hospital
  • Vinnitsa Regional Clinical Oncology Center
  • Zaporozhye Medical Academy of Postgraduate Education
  • Zhitomir Regional Clinical Hospital n.a. O.F. Gerbachevsky

Outcomes

Primary Outcome Measures

Overall Survival

Secondary Outcome Measures

Objective tumor response rate
Duration of objective tumor response rate
Progression-free survival
6 month and 12 month survival
Serum CA 19-9
Pain Intensity
Performance Status

Full Information

First Posted
December 10, 2004
Last Updated
April 28, 2009
Sponsor
Threshold Pharmaceuticals
Collaborators
PPD
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1. Study Identification

Unique Protocol Identification Number
NCT00099294
Brief Title
Study of the Efficacy and Safety of Glufosfamide Compared With Best Supportive Care in Metastatic Pancreatic Cancer
Official Title
A Randomized Phase 3 Study of the Efficacy and Safety of Glufosfamide Compared With Best Supportive Care in Metastatic Pancreatic Adenocarcinoma Previously Treated With Gemcitabine
Study Type
Interventional

2. Study Status

Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
January 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Threshold Pharmaceuticals
Collaborators
PPD

4. Oversight

5. Study Description

Brief Summary
The primary objectives of the study is to evaluate the effectiveness and safety of glufosfamide in subjects with pancreatic cancer who have been previously treated with gemcitabine as measured by overall survival compared with best supportive care.
Detailed Description
TH-CR-302 is a randomized Phase 3 study that will evaluate the efficacy and safety of glufosfamide plus best supportive care (BSC) compared to BSC alone for second line treatment of metastatic pancreatic cancer. BSC includes all medical or surgical interventions that a pancreatic cancer patient should receive to palliate the cancer but excludes treatment with systemic therapies intended to kill the cancer cells. Study Hypothesis: Glufosfamide will provide benefits in survival to patients with metastatic pancreatic cancer over best supportive care. Comparison: Glufosfamide versus best supportive care.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
Pancreas, Cancer, Pancreatic Adenocarcinoma, Metastatic, Glufosfamide

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Glufosfamide
Primary Outcome Measure Information:
Title
Overall Survival
Secondary Outcome Measure Information:
Title
Objective tumor response rate
Title
Duration of objective tumor response rate
Title
Progression-free survival
Title
6 month and 12 month survival
Title
Serum CA 19-9
Title
Pain Intensity
Title
Performance Status

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: At least 18 years of age Pancreatic adenocarcinoma proven either by histology (surgical biopsy) or cytology (CT- or endoscopic-guided) Metastatic pancreatic cancer Disease progression during or after treatment with gemcitabine (alone or in combination with other agents; at regular, not radiosensitizing, doses) for advanced/metastatic pancreatic cancer Measurable or nonmeasurable disease by RECIST criteria (at least one target or nontarget lesion) Recovered from reversible toxicities of prior therapy Karnofsky performance status ≥70 All women of childbearing potential and all men must agree to use effective means of contraception (surgical sterilization or the use of barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel or an IUD) from entry into the study through 6 months after the last dose Ability to understand the purposes and risks of the study and has signed a written informed consent form approved by the investigator's IRB/Ethics Committee Exclusion Criteria: More than one prior systemic therapy regimen for metastatic/locally advanced pancreatic cancer (radiosensitizing doses of 5FU or gemcitabine at the time of initial radiotherapy do not count as a prior systemic therapy regimen) Hormonal therapy, radiation therapy, biologic therapy, chemotherapy or other systemic antitumor therapy for pancreatic cancer within 14 days prior to study start Symptomatic brain metastases (baseline CT scan is not required in asymptomatic subjects) Active clinically significant infection requiring antibiotics Known HIV positive or active hepatitis B or C Recent (one year) history or symptoms of cardiovascular disease (NYHA Class 2, 3, or 4), particularly coronary artery disease, arrhythmias or conduction defects with risk of cardiovascular instability, uncontrolled hypertension, clinically significant pericardial effusion, or congestive heart failure No other active malignancies (other than treated non-melanoma skin cancer or treated in situ cancer) within the past year Major surgery within 3 weeks of the start of study treatment, without complete recovery Clinically significant abnormalities in laboratory test results (including complete blood count, chemistry panel including electrolytes, and urinalysis) (Hemoglobin <9 g/dL (may receive transfusion or erythropoietin to maintain))
Facility Information:
Facility Name
Augusta Oncology Associates
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
Kenmar Research Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
Mile High Oncology
City
Denver
State/Province
Colorado
ZIP/Postal Code
80210
Country
United States
Facility Name
Northwestern Connecticut Oncology - Hematology Associates
City
Torrington
State/Province
Connecticut
ZIP/Postal Code
06790
Country
United States
Facility Name
Palm Beach Institute of Hematology and Oncology
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33435
Country
United States
Facility Name
Hematology/Oncology of the North Shore
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60076
Country
United States
Facility Name
Fort Wayne Medical Oncology/Hem
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46815
Country
United States
Facility Name
Norton Healthcare Center
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
West Michigan Cancer Center
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007
Country
United States
Facility Name
Hattiesburg Clinic Oncology
City
Hattiesburg
State/Province
Mississippi
ZIP/Postal Code
39401
Country
United States
Facility Name
Columbia Comprehensive Cancer Care Clinic
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65201
Country
United States
Facility Name
Bond Clinic
City
Rolla
State/Province
Missouri
ZIP/Postal Code
65401
Country
United States
Facility Name
Deaconess Billings Clinic
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
Office of Clinical Trials
City
Paramus
State/Province
New Jersey
ZIP/Postal Code
07652
Country
United States
Facility Name
New Mexico Oncology Hematology Consultants
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Facility Name
Hanover Medical Specialists
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Vita Hematology Oncology PC
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015
Country
United States
Facility Name
The Family Cancer Center , PLLC
City
Collierville
State/Province
Tennessee
ZIP/Postal Code
38017
Country
United States
Facility Name
Center for Oncology Research and Treatment
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
JPS Center for Cancer Care
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Northern Utah Associates
City
Ogden
State/Province
Utah
ZIP/Postal Code
84403
Country
United States
Facility Name
Cancer Outreach Association
City
Abingdon
State/Province
Virginia
ZIP/Postal Code
24211
Country
United States
Facility Name
Marshfield Clinic Research Foundation
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449
Country
United States
Facility Name
Hospital Interzonal General de Agudos
City
Buenos Aires
ZIP/Postal Code
1650
Country
Argentina
Facility Name
Hospital Posadas
City
Buenos Aires
ZIP/Postal Code
1706
Country
Argentina
Facility Name
Policlinica Privada Instituto de Medicina Nuclear
City
Buenos Aires
ZIP/Postal Code
B8000FTS
Country
Argentina
Facility Name
Hospital Udaondo
City
Buenos Aires
ZIP/Postal Code
C1120AAF
Country
Argentina
Facility Name
Hospital Alvarez
City
Buenos Aires
ZIP/Postal Code
C1406FWY
Country
Argentina
Facility Name
Hospital Churruca - Visca
City
Buenos Aires
ZIP/Postal Code
C1437JCP
Country
Argentina
Facility Name
Instituto Medico Alexander Fleming
City
Buenos Aires
Country
Argentina
Facility Name
Instituto CAICI
City
Santa Fe
Country
Argentina
Facility Name
Fundacao Pio XII - Hospital de Cancer de Barretos
City
Barretos
ZIP/Postal Code
14784-400
Country
Brazil
Facility Name
Fundação Pio XII - Hospital de Câncer de Barretos
City
Barretos
ZIP/Postal Code
14784-400
Country
Brazil
Facility Name
Hospital Vera Cruz - Clinica de Oncologia
City
Belo Horizonte
ZIP/Postal Code
30180-090
Country
Brazil
Facility Name
Hospital Luxemburgo
City
Belo Horizonte
ZIP/Postal Code
30380-490
Country
Brazil
Facility Name
Hospital de Clínicas da UFPR
City
Curitiba
ZIP/Postal Code
80060-900
Country
Brazil
Facility Name
Associacao de Combate ao Cancer em Goias, Hospital Araujo Jorge, Setor de Oncologia Clinica
City
Goiania
ZIP/Postal Code
74605-070
Country
Brazil
Facility Name
Hospital Nossa Senhora da Conceicao
City
Porto Alegre
ZIP/Postal Code
91350-200
Country
Brazil
Facility Name
Instituto Nacional do Cancer - INCA
City
Rio de Janeiro
ZIP/Postal Code
20231-050
Country
Brazil
Facility Name
Clinica de Oncologia Medica S/C Ltda
City
Sao Paulo
ZIP/Postal Code
01406100
Country
Brazil
Facility Name
Hospital do Cancer - AC Camargo
City
Sao Paulo
ZIP/Postal Code
01509-900
Country
Brazil
Facility Name
Grupo Paulista Oncologia Integrada
City
São Paulo
ZIP/Postal Code
01331-020
Country
Brazil
Facility Name
Department of Chemotherapy Dr. Georgi Stranski General Hospital of Pleven University
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
First Internal Department Plovdiv Regional Oncology Center with In-patient Department
City
Plovdiv
ZIP/Postal Code
4004
Country
Bulgaria
Facility Name
Department of Chemotherapy Sofia Regional Oncology Center
City
Sofia
ZIP/Postal Code
1233
Country
Bulgaria
Facility Name
Chemotherapy Clinic Queen Joanna General Hospital
City
Sofia
ZIP/Postal Code
1527
Country
Bulgaria
Facility Name
Haematology and Oncology Clinic Military Medical Academy
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Facility Name
Chemotherapy Clinic Specialized Oncology Hospital
City
Sofia
ZIP/Postal Code
1756
Country
Bulgaria
Facility Name
Department of Chemotherapy Veliko Tarnovo Regional Oncology Center
City
Tarnovo
ZIP/Postal Code
5000
Country
Bulgaria
Facility Name
Department of Medicinal Oncotherapy and Palliative Care Dr. Marko Markov Regional Oncology Center
City
Varna
ZIP/Postal Code
9010
Country
Bulgaria
Facility Name
Fakultni nemocnice Brno Oddeleni Klinicke Onkologie
City
Brno
Country
Czech Republic
Facility Name
Masarykuv onkologicky Ustav
City
Brno
Country
Czech Republic
Facility Name
Krajska nemocnice Pardubice,oddeleni Radiacni Onkologie
City
Kyjevska
Country
Czech Republic
Facility Name
Onkologicka Klinika, Fakultni nemocnice Olomouc
City
Olomouc
Country
Czech Republic
Facility Name
Onkologicke Oddeleni, Batova krajska nemocnice Zlin
City
Zlin
Country
Czech Republic
Facility Name
National Institute of Oncology
City
Budapest
Country
Hungary
Facility Name
Szent Imre Korhaz Onkologia
City
Budapest
Country
Hungary
Facility Name
Szent László Kórház, Onkológia
City
Budapest
Country
Hungary
Facility Name
Vaszary Kolos Korhaz
City
Esztergom
Country
Hungary
Facility Name
Petz Aladar County Hospital, Department of Oncology
City
Gyor
Country
Hungary
Facility Name
Baranya megyei Korhaz Onkologial osztaly
City
Rakoczi
Country
Hungary
Facility Name
Bangalore Institute of Oncology
City
Bangalore
ZIP/Postal Code
560027
Country
India
Facility Name
Curie Centre of Oncology
City
Bangalore
Country
India
Facility Name
Radhakrishan Birla Cancer Centre
City
Jaipur
ZIP/Postal Code
302004
Country
India
Facility Name
Jaslok Hospital and Research Centre
City
Mumbai
ZIP/Postal Code
400026
Country
India
Facility Name
Sir Ganga Ram Hospital
City
New Delhi
Country
India
Facility Name
Hospital Universitario "Dr. Angel Leano"
City
Zapopan
State/Province
Jalisco
ZIP/Postal Code
45200
Country
Mexico
Facility Name
Hospital y Clinica OCA S.A. De C.V.
City
Monterrey
State/Province
NL
ZIP/Postal Code
64000
Country
Mexico
Facility Name
Hospital Central "Dr. Ignacio Morones Prieto" Departamento de Radioterapia.
City
San Luis Potosi
State/Province
SLP
ZIP/Postal Code
78240
Country
Mexico
Facility Name
Hospital regional ISSSTE "Merida"
City
Merida
State/Province
Yucatan
ZIP/Postal Code
97219
Country
Mexico
Facility Name
Centro Estatal de Cancerologia
City
Chihuahua
ZIP/Postal Code
31000
Country
Mexico
Facility Name
Hospital Clinica del Parque
City
Chihuahua
ZIP/Postal Code
31000
Country
Mexico
Facility Name
Centro Medico ISSEMYM
City
Metepec
ZIP/Postal Code
52410
Country
Mexico
Facility Name
Hospital general "5 de Diciembre" ISSSTE
City
Mexicali
ZIP/Postal Code
21100
Country
Mexico
Facility Name
Hospital Regional de Especialidades No. 30 IMSS
City
Mexicali
ZIP/Postal Code
21100
Country
Mexico
Facility Name
Hospital de Oncologia Centro Medico
City
Mexico, DF
ZIP/Postal Code
06720
Country
Mexico
Facility Name
Instituto Nacional de Ciencias Medicas u Nutricion "Salvador Zubiran"
City
Mexico, DF
ZIP/Postal Code
14000
Country
Mexico
Facility Name
Fundeni Clinical Institute
City
Bucharest
Country
Romania
Facility Name
Trestioreanu Institute of Oncology
City
Bucharest
Country
Romania
Facility Name
"I. Chiricuta" Institute of Oncology
City
Cluj-Napoca
Country
Romania
Facility Name
Craiova Emergency Clinical County Hospital
City
Craiova
ZIP/Postal Code
1100
Country
Romania
Facility Name
Timisoara City Hospital
City
Timisoara
Country
Romania
Facility Name
Institute of Medical Radiology, Russian Academy of Medical Science
City
Obninsk
State/Province
Kaluzhskaya Region
ZIP/Postal Code
249020
Country
Russian Federation
Facility Name
Cheliabinsk Regional Oncology Center
City
Cheliabinsk
ZIP/Postal Code
454087
Country
Russian Federation
Facility Name
Irkutsk Regional Oncology Center
City
Irkutsk
ZIP/Postal Code
664035
Country
Russian Federation
Facility Name
Clinical Oncology Center
City
Kazan
ZIP/Postal Code
420029
Country
Russian Federation
Facility Name
Krasnodar City Oncology Center
City
Krasnodar
ZIP/Postal Code
350040
Country
Russian Federation
Facility Name
Blokhin Cancer Research Center, Dept of Clinical Pharmacology and Chemotherapy
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Central Clinical Hospital of the presidentof the Russian Federation
City
Moscow
ZIP/Postal Code
121356
Country
Russian Federation
Facility Name
Hertzen Research Institute of Oncology
City
Moscow
ZIP/Postal Code
125284
Country
Russian Federation
Facility Name
Central Clinical Hospital of the Ministru of Transport n.a. Semashko
City
Moscow
ZIP/Postal Code
129128
Country
Russian Federation
Facility Name
Orenburg, Regional Oncology Center
City
Orenburg
ZIP/Postal Code
460021
Country
Russian Federation
Facility Name
Samara Oncology Center
City
Samara
ZIP/Postal Code
443066
Country
Russian Federation
Facility Name
St. Petersburg, Central Research Institute of Radiology
City
St. Petersburg
ZIP/Postal Code
189646
Country
Russian Federation
Facility Name
Medical Academy of Postgraduate Education
City
St. Petersburg
ZIP/Postal Code
193015
Country
Russian Federation
Facility Name
St. Petersburg Oncology Center
City
St. Petersburg
Country
Russian Federation
Facility Name
Mechnikov State Medical Academy
City
St.Petersburg
ZIP/Postal Code
195065
Country
Russian Federation
Facility Name
Voronezh Regional Clinical Oncology Center
City
Voronezh
ZIP/Postal Code
394000
Country
Russian Federation
Facility Name
Yaroslavl Regional Oncology Center
City
Yaroslavl
ZIP/Postal Code
150054
Country
Russian Federation
Facility Name
Dnepropetrovsk City Clinical Hospital
City
Dnepropetrovsk
ZIP/Postal Code
49102
Country
Ukraine
Facility Name
Donetsk Regional Antitumor Center
City
Donetsk
ZIP/Postal Code
83092
Country
Ukraine
Facility Name
State Communal Healthcare Institution: Kharkov Regional Clinical Oncological Center
City
Kharkov
ZIP/Postal Code
61070
Country
Ukraine
Facility Name
Institute of Oncology under the Academy of Medical Sciences of Ukraine
City
Kiev
ZIP/Postal Code
03022
Country
Ukraine
Facility Name
Kiev Municipal Clinical Hospital #10, Kiev Center for Biliary, Biliary tracts and Pancreas Surgery
City
Kiev
ZIP/Postal Code
03039
Country
Ukraine
Facility Name
Krivoy Rog City Oncology Center
City
Krivoy Rog
ZIP/Postal Code
50048
Country
Ukraine
Facility Name
Lugansk Regional Clinical Oncological Center
City
Lugansk
ZIP/Postal Code
91047
Country
Ukraine
Facility Name
Nikolaev Regional Oncology Centre
City
Nikolaev
ZIP/Postal Code
54044
Country
Ukraine
Facility Name
Odessa Regional Clinical Hospital
City
Odessa
ZIP/Postal Code
65025
Country
Ukraine
Facility Name
Vinnitsa Regional Clinical Oncology Center
City
Vinnitsa
ZIP/Postal Code
21029
Country
Ukraine
Facility Name
Zaporozhye Medical Academy of Postgraduate Education
City
Zaporozhye
ZIP/Postal Code
69096
Country
Ukraine
Facility Name
Zhitomir Regional Clinical Hospital n.a. O.F. Gerbachevsky
City
Zhitomir
ZIP/Postal Code
10002
Country
Ukraine

12. IPD Sharing Statement

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Study of the Efficacy and Safety of Glufosfamide Compared With Best Supportive Care in Metastatic Pancreatic Cancer

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