Back to resultsA Study Comparing CO-1.01 With Gemcitabine as First Line Therapy in Patients With Metastatic Pancreatic Adenocarcinoma (LEAP)
Primary Purpose
Metastatic Pancreatic Adenocarcinoma
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
CO-1.01
Gemcitabine
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Pancreatic Adenocarcinoma focused on measuring cancer, metastatic, pancreatic, pancreas, adenocarcinoma, gemcitabine, human equilibrative nucleoside transporter-1 (hENT1), CO-1.01, CO-101, CO101, Stage 4, Stage IV
Eligibility Criteria
Inclusion Criteria:
- Metastatic pancreatic ductal adenocarcinoma (i.e., Stage 4).
- Histological/cytological confirmation of metastatic tissue (not primary tumor) by a central pathology laboratory (H&E stain) to ensure sufficient material is available for later hENT1 analysis.
- Adjuvant chemotherapy/radiotherapy ≥ 6 months prior to randomization.
- Palliative radiotherapy (if administered) ≥ 1 month prior to randomization.
- CT scan ≤30 days prior to randomization
- Performance Status (ECOG) 0 or 1.
- Estimated life expectancy ≥ 12 weeks.
- Age ≥ 18 years.
- Adequate hematological and biological function.
- Written consent on an Institutional Review Board/Institutional Ethics Committee-approved Informed Consent Form prior to any study-specific evaluation.
Exclusion Criteria:
- Prior palliative chemotherapy for pancreatic cancer.
- Radical pancreatic resections (e.g., Whipple procedure) are not allowed < 6 months prior to randomization. Exploratory laparotomy, palliative (e.g., bypass) surgery, or other procedures (e.g., stents) are not allowed < 14 days prior to randomization. In both cases the patient must be sufficiently recovered and stable.
- Symptomatic brain metastases.
- Participation in other investigational drug clinical studies ≤ 30 days prior to randomization.
- Concomitant treatment with prohibited medications.
- History of allergy to gemcitabine or eggs.
- Presence of any serious or unstable concomitant systemic disorder incompatible with the clinical study (e.g., substance abuse, uncontrolled intercurrent illness including active infection, arterial thrombosis, symptomatic pulmonary embolism).
- Any disorder that would hamper protocol compliance.
- Prior nonpancreatic malignancy treated with chemotherapy. Prior malignancies treated with surgery or radiotherapy alone must be in remission ≥ 3 years. The following prior malignancies are allowable irrespective of when they occurred: in situ carcinoma of the cervix, in situ ductal breast cancer, low-grade local bladder cancer, and nonmelanotic skin cancer.
- Females who are pregnant or breastfeeding.
- Refusal to use adequate contraception for fertile patients (females and males during the study and for 6 months after the last study treatment). Adequate forms of contraception are double-barrier methods (condoms or diaphragm with spermicidal jelly or foam); oral, depot, or injectable contraceptives; intrauterine devices; tubal ligation.
- Any other reason the investigator considers the patient should not participate in the study.
Sites / Locations
- Arizona Center for Hematology Oncology
- Wilshire Oncology Medical Group, Inc.
- White Memorial Medical Center
- Cancer Care Institute
- Newport Cancer Care Medical
- Hematology Oncology Associates
- Sharp Clinical Oncology Research
- Rocky Mountain Cancer Centers
- Hartford Hospital Clinical Research
- Oncology Associates of Bridgeport
- Annapolis Oncology Center
- Virginia Piper Cancer Institute
- The Cancer Institute of New Jersey
- New Mexico Cancer Care Alliance
- Arena Oncology Associates, PC
- Bend Memorial Clinic
- Cancer Center of the Carolinas
- Cancer Specialists of South Texas, P.A.
- Valley Cancer Associates
- South Texas Oncology and Hematology, PA
- Medical College of Wisconsin
- Policlínica Privada Instituto de Medicina Nuclear
- Instituto Especializado Alexander Fleming
- Hospital de Gastroenterología
- Clínica Universitaria Reina Fabiola
- ISIS Centro Especializado
- Newcastle Private Hospital
- Port Macquarie Base Hospital
- Southern Medical Day Oncology Care Centre
- Flinders Medical Centre
- Saint Vincent's Hospital
- Border Medical Oncology, Murray Valley Private Hospital
- Universitair Ziekenhuis Antwerpen
- Cliniques Universitaires Saint Luc
- Centre Hospitalier de Jolimont-Lobbes
- Hospital Universitario
- Santa Casa de Misericordia de Belo Horizonte
- Irmandade da Santa
- Hospital São Lucas - PUCRS
- CEPON-Centro de pesquisas Oncologicas
- Hospital do Cancer de Barretos
- Fundacao Hospital
- Faculdade de Medicina do ABC
- Instituto Nacional do Cancer
- Cross Cancer Institute
- Centre Hospitalier de la Cote Basque
- Hôpital Saint André, Service d'Oncologie Médicale
- Clinique François Chénieux
- Centre Hospitalier Régional Universitaire Hôpital Saint Eloi
- Centre Regional de Lutte contre le Cancer Val d'Aurelle
- Centre René Gauducheau
- Institut Gustave-Roussy - Centre de Lutte Contre le Cancer
- Ludwig-Maximilians-Universität, Medizinische Klinik und Poliklinikversität München
- Klinikum der Ernst-Moritz-Arndt-Universität
- Knappschaftskrankenhaus Bochum-Langendreer
- Universitätsklinikum Jena
- Charité Universitätsmedizin Berlin
- Universitätsklinikum Carl Gustav Carus
- Klinik der Otto-Von-Guericke-Universität Magdeburg
- Medizinische Universitätsklinik Ulm, Abt. Innere Medizin I
- Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi
- Fondazione San Raffaele del Monte Tabor
- Instituto Oncologico Veneto, Oncologia Medica 1
- Ospedali Riuniti di Ancona
- Centro Ricerche Cliniche di Verona
- Vrije Universiteit Medisch Centrum
- Sørlandet sykehus HF
- Oslo Universitetssykehus, Ullevål
- Republic Clinical Oncology Center
- Sverdlovsk Regional Oncology Center
- Regional Oncology Center
- Clinical Oncology Center #1
- Kursk Regional Oncology Center
- Blokhin Cancer Research Center
- Novosibirsk, City Clinical Hospital #1
- Leningrad Regional Clinical Hospital
- Mechnikov St. Petersburg State Medical Academy
- St. Petersburg City Oncology Center
- Tambov Regional Oncology Center
- Tula Regional Oncology Center
- Regional Clinical Oncology Hospital
- Lanssjukhuset Ryhov
- Linköping University Hospital
- Växjö Centrallasarettet
- Dnipropetrovsk City Multispecialty Clinical Hospital #4, Department of Chemotherapy, Dnipropetrovsk State Medical Academy, Department of Oncology and Medical Radiology
- Public Clinical Treatment and Prophylaxis Institution "Donetsk Regional Antitumor Center", Oncosurgery Department #6
- "Public Healthcare Institution ""Kharkiv Regional Clinical Oncology Center"", Abdominal Department
- National Cancer Institute, Department of Tumors of Abdominal Cavity and Retroperitoneum
- State Regional Diagnostics and Treatment Oncology Center, Chemotherapy Department
- Mykolayiv Regional Oncology Center, Surgery Department #1
- Zakarpatya Regional Clinical Oncology Center, Chemotherapy Department
- Clinical Facility: Public Institution "Zaporizhya City Clinical Hospital #3", Regional Center of Hepatic, Biliary Tract and Pancreatic Surgery, Surgery Department #1
- Hammersmith Hospital
- Christie Hospital
- Beatson West of Scotland Cancer Centre, Cancer Research UK Clinical Trials Unit (CTU)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
CO-1.01
gemcitabine
Arm Description
Outcomes
Primary Outcome Measures
Overall Survival in Patients With Low High Human Equilibrative Nucleoside Transporter 1 (hENT1) Expression
Secondary Outcome Measures
Overall Survival in All Patients and Patients With hENT1 Expression
ORR, Duration of Response, and Progression Free Survival (PFS) in Patients With Measurable/Evaluable Disease, Using RECIST 1.1, up to 1.5 Years
Cancer Antigen (CA)19-9 Response Rates
Drug Tolerability and Toxicity
Change From Baseline in Pain Severity
Change From Baseline in Health Status
Pharmacokinetic (PK) Profile of CO-1.01 Based on Sparse Sampling
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01124786
Brief Title
A Study Comparing CO-1.01 With Gemcitabine as First Line Therapy in Patients With Metastatic Pancreatic Adenocarcinoma (LEAP)
Official Title
A Phase II Randomized, Open-Label, Multicenter Study Comparing CO-1.01 With Gemcitabine as First-Line Therapy in Patients With Metastatic Pancreatic Adenocarcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Clovis Oncology, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine whether CO-1.01 is safe and effective in the treatment of patients with metastatic pancreatic cancer and low hENT1 expression compared with gemcitabine.
Detailed Description
Pancreatic cancer is a very serious form of cancer. The majority of patients present with unresectable disease, and the condition is often not diagnosed until the cancer is relatively advanced. The standard first-line treatment for patients with unresectable pancreatic cancer is gemcitabine monotherapy. Unfortunately many of these patients fail to derive benefit from this treatment. No clinical or molecular marker has been established to predict benefit from gemcitabine therapy, so patients are treated empirically until evidence of disease progression or worsening performance status.
The potential for human equilibrative nucleoside transporter-1 (hENT1) expression to predict survival in gemcitabine-treated patients has been studied, and data suggest that patients with low levels of tumor cell hENT1 expression derive less benefit from gemcitabine treatment than patients with high levels of tumor cell hENT1 expression. These data support the hypothesis to be tested in this study that patients with pancreatic tumors expressing low levels of hENT1 will derive minimal benefit from gemcitabine, but will receive benefit from CO-1.01 (gemcitabine elaidate) which enters tumor cells in a hENT1-independent fashion.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Pancreatic Adenocarcinoma
Keywords
cancer, metastatic, pancreatic, pancreas, adenocarcinoma, gemcitabine, human equilibrative nucleoside transporter-1 (hENT1), CO-1.01, CO-101, CO101, Stage 4, Stage IV
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
367 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CO-1.01
Arm Type
Experimental
Arm Title
gemcitabine
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
CO-1.01
Intervention Description
1250 mg/m2 intravenous infusion weekly for 3 weeks every 4 weeks
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Description
1000 mg/m2 intravenous infusion weekly for 7 weeks followed by 1 week rest, then weekly for 3 weeks every 4 weeks
Primary Outcome Measure Information:
Title
Overall Survival in Patients With Low High Human Equilibrative Nucleoside Transporter 1 (hENT1) Expression
Time Frame
Monthly follow up after treatment discontinuation until death, up to 1.5 years.
Secondary Outcome Measure Information:
Title
Overall Survival in All Patients and Patients With hENT1 Expression
Time Frame
Monthly follow up after treatment discontinuation until death, up to 1.5 years
Title
ORR, Duration of Response, and Progression Free Survival (PFS) in Patients With Measurable/Evaluable Disease, Using RECIST 1.1, up to 1.5 Years
Time Frame
Every 8 weeks
Title
Cancer Antigen (CA)19-9 Response Rates
Time Frame
Every 4 weeks, up to 1.5 years
Title
Drug Tolerability and Toxicity
Time Frame
Every week, up to 1.5 years
Title
Change From Baseline in Pain Severity
Time Frame
Every 4 weeks, up to 1.5 years
Title
Change From Baseline in Health Status
Time Frame
Every 4 weeks, up to 1.5 years
Title
Pharmacokinetic (PK) Profile of CO-1.01 Based on Sparse Sampling
Time Frame
30 days after first dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Metastatic pancreatic ductal adenocarcinoma (i.e., Stage 4).
Histological/cytological confirmation of metastatic tissue (not primary tumor) by a central pathology laboratory (H&E stain) to ensure sufficient material is available for later hENT1 analysis.
Adjuvant chemotherapy/radiotherapy ≥ 6 months prior to randomization.
Palliative radiotherapy (if administered) ≥ 1 month prior to randomization.
CT scan ≤30 days prior to randomization
Performance Status (ECOG) 0 or 1.
Estimated life expectancy ≥ 12 weeks.
Age ≥ 18 years.
Adequate hematological and biological function.
Written consent on an Institutional Review Board/Institutional Ethics Committee-approved Informed Consent Form prior to any study-specific evaluation.
Exclusion Criteria:
Prior palliative chemotherapy for pancreatic cancer.
Radical pancreatic resections (e.g., Whipple procedure) are not allowed < 6 months prior to randomization. Exploratory laparotomy, palliative (e.g., bypass) surgery, or other procedures (e.g., stents) are not allowed < 14 days prior to randomization. In both cases the patient must be sufficiently recovered and stable.
Symptomatic brain metastases.
Participation in other investigational drug clinical studies ≤ 30 days prior to randomization.
Concomitant treatment with prohibited medications.
History of allergy to gemcitabine or eggs.
Presence of any serious or unstable concomitant systemic disorder incompatible with the clinical study (e.g., substance abuse, uncontrolled intercurrent illness including active infection, arterial thrombosis, symptomatic pulmonary embolism).
Any disorder that would hamper protocol compliance.
Prior nonpancreatic malignancy treated with chemotherapy. Prior malignancies treated with surgery or radiotherapy alone must be in remission ≥ 3 years. The following prior malignancies are allowable irrespective of when they occurred: in situ carcinoma of the cervix, in situ ductal breast cancer, low-grade local bladder cancer, and nonmelanotic skin cancer.
Females who are pregnant or breastfeeding.
Refusal to use adequate contraception for fertile patients (females and males during the study and for 6 months after the last study treatment). Adequate forms of contraception are double-barrier methods (condoms or diaphragm with spermicidal jelly or foam); oral, depot, or injectable contraceptives; intrauterine devices; tubal ligation.
Any other reason the investigator considers the patient should not participate in the study.
Facility Information:
Facility Name
Arizona Center for Hematology Oncology
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85306
Country
United States
Facility Name
Wilshire Oncology Medical Group, Inc.
City
Corona
State/Province
California
ZIP/Postal Code
92879
Country
United States
Facility Name
White Memorial Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Cancer Care Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90036
Country
United States
Facility Name
Newport Cancer Care Medical
City
Newport Beach
State/Province
California
ZIP/Postal Code
92660
Country
United States
Facility Name
Hematology Oncology Associates
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
Facility Name
Sharp Clinical Oncology Research
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Rocky Mountain Cancer Centers
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Hartford Hospital Clinical Research
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06102
Country
United States
Facility Name
Oncology Associates of Bridgeport
City
Trumbull
State/Province
Connecticut
ZIP/Postal Code
06611
Country
United States
Facility Name
Annapolis Oncology Center
City
Annapolis
State/Province
Maryland
ZIP/Postal Code
21401
Country
United States
Facility Name
Virginia Piper Cancer Institute
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
The Cancer Institute of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
New Mexico Cancer Care Alliance
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Facility Name
Arena Oncology Associates, PC
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Bend Memorial Clinic
City
Bend
State/Province
Oregon
ZIP/Postal Code
97701
Country
United States
Facility Name
Cancer Center of the Carolinas
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Cancer Specialists of South Texas, P.A.
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78412
Country
United States
Facility Name
Valley Cancer Associates
City
Harlingen
State/Province
Texas
ZIP/Postal Code
78550
Country
United States
Facility Name
South Texas Oncology and Hematology, PA
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Policlínica Privada Instituto de Medicina Nuclear
City
Buenos Aires
State/Province
Bahia Blanca
ZIP/Postal Code
B8000FJI
Country
Argentina
Facility Name
Instituto Especializado Alexander Fleming
City
Cuidad Autónoma de Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
C1426ANZ
Country
Argentina
Facility Name
Hospital de Gastroenterología
City
Loma Hermosa
State/Province
Buenos Aires
ZIP/Postal Code
B1657BHD
Country
Argentina
Facility Name
Clínica Universitaria Reina Fabiola
City
Córdoba
ZIP/Postal Code
X5004FHP
Country
Argentina
Facility Name
ISIS Centro Especializado
City
Santa Fe
ZIP/Postal Code
S3000FFU
Country
Argentina
Facility Name
Newcastle Private Hospital
City
New Lambton Heights
State/Province
New South Wales
ZIP/Postal Code
2305
Country
Australia
Facility Name
Port Macquarie Base Hospital
City
Port Macquarie
State/Province
New South Wales
ZIP/Postal Code
2444
Country
Australia
Facility Name
Southern Medical Day Oncology Care Centre
City
Wollongong
State/Province
New South Wales
ZIP/Postal Code
2500
Country
Australia
Facility Name
Flinders Medical Centre
City
Bedford Park
State/Province
South Australia
ZIP/Postal Code
5042
Country
Australia
Facility Name
Saint Vincent's Hospital
City
Fitzroy
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
Facility Name
Border Medical Oncology, Murray Valley Private Hospital
City
Wodonga
State/Province
Victoria
ZIP/Postal Code
3690
Country
Australia
Facility Name
Universitair Ziekenhuis Antwerpen
City
Edegem
State/Province
Antwerpen
ZIP/Postal Code
2650
Country
Belgium
Facility Name
Cliniques Universitaires Saint Luc
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Centre Hospitalier de Jolimont-Lobbes
City
Haine-Saint-Paul
ZIP/Postal Code
7100
Country
Belgium
Facility Name
Hospital Universitario
City
Brasilia
State/Province
Distrito Federal
ZIP/Postal Code
70840
Country
Brazil
Facility Name
Santa Casa de Misericordia de Belo Horizonte
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
60430-230
Country
Brazil
Facility Name
Irmandade da Santa
City
Porto Alegre
State/Province
Rio Grande do Sul
ZIP/Postal Code
90020
Country
Brazil
Facility Name
Hospital São Lucas - PUCRS
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90610-000
Country
Brazil
Facility Name
CEPON-Centro de pesquisas Oncologicas
City
Florianópolis
State/Province
Santa Catarina
ZIP/Postal Code
88034-000
Country
Brazil
Facility Name
Hospital do Cancer de Barretos
City
Barretos
State/Province
Sao Paulo
ZIP/Postal Code
14784-400
Country
Brazil
Facility Name
Fundacao Hospital
City
Jau
State/Province
Sao Paulo
ZIP/Postal Code
17210
Country
Brazil
Facility Name
Faculdade de Medicina do ABC
City
Santo Andre
State/Province
Sao Paulo
ZIP/Postal Code
09060-650
Country
Brazil
Facility Name
Instituto Nacional do Cancer
City
Rio de Janeiro
ZIP/Postal Code
20231
Country
Brazil
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
Centre Hospitalier de la Cote Basque
City
Bayonne Cedex
ZIP/Postal Code
64109
Country
France
Facility Name
Hôpital Saint André, Service d'Oncologie Médicale
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
Clinique François Chénieux
City
Limoges Cedex
ZIP/Postal Code
87039
Country
France
Facility Name
Centre Hospitalier Régional Universitaire Hôpital Saint Eloi
City
Montpellier Cedex 5
ZIP/Postal Code
34295
Country
France
Facility Name
Centre Regional de Lutte contre le Cancer Val d'Aurelle
City
Montpellier
ZIP/Postal Code
34298
Country
France
Facility Name
Centre René Gauducheau
City
Saint Herblain cedex
ZIP/Postal Code
44805
Country
France
Facility Name
Institut Gustave-Roussy - Centre de Lutte Contre le Cancer
City
Villejuif Cedex
ZIP/Postal Code
94805
Country
France
Facility Name
Ludwig-Maximilians-Universität, Medizinische Klinik und Poliklinikversität München
City
München
State/Province
Bayern
ZIP/Postal Code
81377
Country
Germany
Facility Name
Klinikum der Ernst-Moritz-Arndt-Universität
City
Greifswald
State/Province
Mecklenburg-Vorpommern
ZIP/Postal Code
17475
Country
Germany
Facility Name
Knappschaftskrankenhaus Bochum-Langendreer
City
Bochum
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
44892
Country
Germany
Facility Name
Universitätsklinikum Jena
City
Jena
State/Province
Thueringen
ZIP/Postal Code
07740
Country
Germany
Facility Name
Charité Universitätsmedizin Berlin
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Universitätsklinikum Carl Gustav Carus
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Klinik der Otto-Von-Guericke-Universität Magdeburg
City
Magdeburg
ZIP/Postal Code
39120
Country
Germany
Facility Name
Medizinische Universitätsklinik Ulm, Abt. Innere Medizin I
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi
City
Bologna
State/Province
Emilia-Romagna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Fondazione San Raffaele del Monte Tabor
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
Instituto Oncologico Veneto, Oncologia Medica 1
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Ospedali Riuniti di Ancona
City
Torrette di Ancona
ZIP/Postal Code
60020
Country
Italy
Facility Name
Centro Ricerche Cliniche di Verona
City
Verona
ZIP/Postal Code
37134
Country
Italy
Facility Name
Vrije Universiteit Medisch Centrum
City
Amsterdam
State/Province
Noord-Holland
ZIP/Postal Code
1081 HV
Country
Netherlands
Facility Name
Sørlandet sykehus HF
City
Kristiansand
ZIP/Postal Code
4604
Country
Norway
Facility Name
Oslo Universitetssykehus, Ullevål
City
Oslo
ZIP/Postal Code
0407
Country
Norway
Facility Name
Republic Clinical Oncology Center
City
Izhevsk
State/Province
Republic of Udmurtia
ZIP/Postal Code
426067
Country
Russian Federation
Facility Name
Sverdlovsk Regional Oncology Center
City
Ekaterinburg
ZIP/Postal Code
620036
Country
Russian Federation
Facility Name
Regional Oncology Center
City
Irkutsk
ZIP/Postal Code
664035
Country
Russian Federation
Facility Name
Clinical Oncology Center #1
City
Krasnodar
ZIP/Postal Code
350040
Country
Russian Federation
Facility Name
Kursk Regional Oncology Center
City
Kursk
ZIP/Postal Code
305035
Country
Russian Federation
Facility Name
Blokhin Cancer Research Center
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Novosibirsk, City Clinical Hospital #1
City
Novosibirsk
ZIP/Postal Code
630047
Country
Russian Federation
Facility Name
Leningrad Regional Clinical Hospital
City
St. Petersburg
ZIP/Postal Code
194291
Country
Russian Federation
Facility Name
Mechnikov St. Petersburg State Medical Academy
City
St. Petersburg
ZIP/Postal Code
195067
Country
Russian Federation
Facility Name
St. Petersburg City Oncology Center
City
St. Petersburg
ZIP/Postal Code
197785
Country
Russian Federation
Facility Name
Tambov Regional Oncology Center
City
Tambov
ZIP/Postal Code
392013
Country
Russian Federation
Facility Name
Tula Regional Oncology Center
City
Tula
ZIP/Postal Code
300053
Country
Russian Federation
Facility Name
Regional Clinical Oncology Hospital
City
Yaroslavl
ZIP/Postal Code
150040
Country
Russian Federation
Facility Name
Lanssjukhuset Ryhov
City
Jonkoping
ZIP/Postal Code
551 85
Country
Sweden
Facility Name
Linköping University Hospital
City
Linköping
ZIP/Postal Code
581 85
Country
Sweden
Facility Name
Växjö Centrallasarettet
City
Växjö
ZIP/Postal Code
351 85
Country
Sweden
Facility Name
Dnipropetrovsk City Multispecialty Clinical Hospital #4, Department of Chemotherapy, Dnipropetrovsk State Medical Academy, Department of Oncology and Medical Radiology
City
Dnipropetrovsk
ZIP/Postal Code
49102
Country
Ukraine
Facility Name
Public Clinical Treatment and Prophylaxis Institution "Donetsk Regional Antitumor Center", Oncosurgery Department #6
City
Donetsk
ZIP/Postal Code
83092
Country
Ukraine
Facility Name
"Public Healthcare Institution ""Kharkiv Regional Clinical Oncology Center"", Abdominal Department
City
Kharkiv
ZIP/Postal Code
61070
Country
Ukraine
Facility Name
National Cancer Institute, Department of Tumors of Abdominal Cavity and Retroperitoneum
City
Kiev
ZIP/Postal Code
03022
Country
Ukraine
Facility Name
State Regional Diagnostics and Treatment Oncology Center, Chemotherapy Department
City
Lviv
ZIP/Postal Code
79031
Country
Ukraine
Facility Name
Mykolayiv Regional Oncology Center, Surgery Department #1
City
Mykolayiv
ZIP/Postal Code
54044
Country
Ukraine
Facility Name
Zakarpatya Regional Clinical Oncology Center, Chemotherapy Department
City
Uzhorod
ZIP/Postal Code
88014
Country
Ukraine
Facility Name
Clinical Facility: Public Institution "Zaporizhya City Clinical Hospital #3", Regional Center of Hepatic, Biliary Tract and Pancreatic Surgery, Surgery Department #1
City
Zaporizhya
ZIP/Postal Code
69032
Country
Ukraine
Facility Name
Hammersmith Hospital
City
London
State/Province
England
ZIP/Postal Code
W12 0HS
Country
United Kingdom
Facility Name
Christie Hospital
City
Manchester
State/Province
England
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Beatson West of Scotland Cancer Centre, Cancer Research UK Clinical Trials Unit (CTU)
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G12 0YN
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
A Study Comparing CO-1.01 With Gemcitabine as First Line Therapy in Patients With Metastatic Pancreatic Adenocarcinoma (LEAP)
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