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GV1001 and Gemcitabine in Sequential Combination to Gemcitabine Monotherapy in Pancreatic Cancer

Primary Purpose

Advanced Unresectable Pancreatic Cancer

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
GV1001
Gemcitabine (Chemotherapy)
Sponsored by
Pharmexa A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Unresectable Pancreatic Cancer focused on measuring Advanced, Unresesctable, Adenocarcinoma, Pancreatic cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Histologically or cytologically confirmed, unresectable, locally advanced, or metastatic adenocarcinoma of the pancreas. Adequate hematological parameters: Hemoglobin >/= 9.5 g/dL [SI units, 5.9 mmol/L] WBC >/= 3000/mm3 [SI units, >/= 3 x 109/L] Platelets >/= 100,000/mm3 [SI units, >/= 100 x 109/L] Adequate baseline liver function: Total Bilirubin < 3x ULN and Without liver metastases: AST (SGOT) </= 2.5 x ULN ALT (SGPT) </= 2.5 x ULN With liver metastases: AST (SGOT) </= 5 x ULN ALT (SGPT) </= 5 x ULN Serum creatinine </= 1.5 mg/dL [SI units, 132 µmol/L]. Performance status ECOG 0-1. Male or female 18 - 75 years inclusive. Minimum life expectancy of 3 months. Written informed consent. Exclusion Criteria: Treatment with chemotherapy for pancreatic cancer. Treatment with other investigational drugs within the last 4 weeks prior to inclusion Immune-suppressive therapy <4 weeks prior to inclusion Chronic corticosteroid use except for asthma inhalers / topical use Radiotherapy within 8 weeks of randomisation. Other prior malignancies except for adequately treated non-melanoma skin cancers (BCC, SCC) and carcinoma in situ of the cervix. Known diagnosis of HIV (AIDS), Hepatitis B, C. Known history of or co-existing autoimmune disease. Known CNS metastases. Clinically significant serious disease or organ system disease not currently controlled on present therapy. Pregnancy or lactation. Women of childbearing potential not using reliable and adequate contraceptive methods* Known sensitivity to any components of vaccine, gemcitabine or GM-CSF. Unable for any other reason to comply with the protocol (treatment or assessments). Adequate contraceptive methods are defined as the use of oral, implanted, injectable, mechanical or barrier products for the prevention of pregnancy; or women who are practising abstinence; or where the partner is sterile, for example a vasectomy.

Sites / Locations

  • University of South Alabama Mitchell Cancer Institute
  • Genesis Cancer Center
  • Scripps Clinic Torrey Pines
  • Desert Hematology Oncology Medical Group, Inc.
  • The Center for Hematology-Oncology
  • Tampa General Hospital Usf Digestive Disorders Centre
  • Palm Beach Cancer Institute
  • Portneuf Cancer Center
  • Oncology Hematology Associates of Central Illinois, PC
  • Hematology Oncology Specialists, Covington
  • Berskhire Hematology Oncology PC
  • Billings Clinic
  • Carolinas Hematology Oncology Associates
  • Gabrail Cancer Center
  • Toledo Community Hospital Oncology Program
  • Southwest Regional Cancer Center
  • Mary Crowley Medical Research Center (MCMRC)Texas Oncology-Presbyrerian Hospital of Dallas
  • Mary Crowley Medical Research Center, Worth St.
  • Oncology Consultants, PA
  • St George Hospital, Department of Medical Oncology
  • Westmead Hospital, Dept. of Medical Oncology and Palliative Care
  • The Townsville Hospital, Townsville Cancer Centre
  • Flinders Medical Centre, Medical Oncology - Clinical Trials
  • Dept. of Clinical Haematology / Oncology,the Queen Elizabeth Hospital
  • Royal Hobart Hospital, Centre for Clinical Research
  • Box Hill Hospital, ECRU Oncology
  • The Alfred Hospital, Medical Oncology Unit
  • Fremantle Hospital, Haemtology Department
  • Sir Charles Gairdner Hospital
  • Mount Medical Centre, Perth Oncology
  • Royal Perth Hospital, Department of Medical Oncology
  • Wesley Research Institute Limited
  • Erasms University Hospital
  • Hospital De Jolimont
  • Ghent University Hospital, Digestive Oncology
  • Oncology Department, Herlev Hospital
  • Odense Universitetshospital, Onkologisk afd. R
  • Oncology Department, Århus Hospital
  • Centre d'Etudes Cliniques en Oncologie, Centre Paul Papin
  • Oncologie Medicale, Clinic Pasteur
  • Hepatogastroenterology Dpt, University Hospital Center of Grenoble
  • Service de Medicine Interne, CHRU de Lille
  • Oncologie Midicale CHR Lorient
  • Hôpital de la Roche / Yon <<Les Oudaires>>, Centre Hospitalier Départmentale
  • Oncologie Médicale, Centre Cathrine de Siennes
  • Service de Cancerologie, Hospital Europeen Georges Pompidou
  • Medical Oncology Dpt, Armoricaine Private Hospital of Radiology
  • Clinic Saint Vincent
  • Oncology Trials Unit, Cork University Hospital
  • Cancer Clinical Trials Unit, Beaumont Hospital
  • Cancer Research Unit, Mater Misericordlae University Hospital
  • Department of Medical Oncology, Amnch
  • Oncology Research Team, Mater Private University Hospital
  • Medical Oncology, University "Politecnica Delle Marche", Oncologia Medica Universita
  • Policlinico Universitario "Mater Domini", Unita Oncologia
  • Hospital "Careggi", Medical Oncology
  • Azienda Ospedaliera, Arcispedale S. Maria Nuova
  • Hospital "G.B. Rossi", Surgical and Gastroenterological Dept. Borgo Roma
  • VU University Medical Center
  • Department of Oncology, Haukeland University Hospital, G.I. & Urogenital Oncology
  • Sorlandet Hospital, Senter for Kreftbehandling
  • Ullevål Universitetssykehus, Gastrokirurgisk afd.
  • Department of Oncology, University Hospital of Northern-Norway
  • Bialstocki Osrodek Onkologiczny, Oddzial Chemioterapii Nowotworow I Chorob Wewnetrznych
  • W.S2.Z, Krolewiecka
  • Wojewodzki Szpital Specjalistyczny im.Rydgiera, Oddzial Chemioterapii
  • Klinika Chemioterapii Uniwersytetu Medycznego w Lodzi, Medical University
  • Zaklad Opieki Zdrowotnej MSWiA
  • Centrum Onkologii, Wosewodzki Osrodek Onkologii
  • Dolnoslaskie Centrum Onkologii, Oddzial Chemioterapii
  • Hospital Clinic I Provincial De Barcelona
  • Medical Oncology Department, General Hospital of Baza
  • Medical Oncology Department, Virgen de Las Nieves Hospital
  • Hospital Universitario Gregorio Marañón, Departamento de Oncología
  • Clínica Puerta de Hierro, Departamento de Oncología
  • Hospital Universitario La Paz, Departamento de Oncología
  • H. Monteprincipe
  • Fundaciόn Hospital de Alcorcόn, Unidad de Oncología
  • HRU Carlos Haya, Medical Oncology Unit
  • Oncology Department, Clinic Universitary Hospital
  • Digestive Unit, Universitary Hospital Virgen de La Macarena
  • Sahlgrenska Hospital, Head Division for Upper GI Surgery
  • University Hospital, Department Of surgery and Gasterenterology
  • Department of Oncology, Malmö University Hospital
  • Karolinska Institute / Hospital Solna, Department of Oncology
  • Department of Oncology, Karolinska Universitetssjukhuset

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Gemcitabine

GV1001

Arm Description

Gemcitabine alone treatment.

GV1001 in sequential combination with Gemcitabine

Outcomes

Primary Outcome Measures

Overall survival time

Secondary Outcome Measures

Progression Free Survival

Full Information

First Posted
July 14, 2006
Last Updated
May 16, 2008
Sponsor
Pharmexa A/S
Collaborators
ICON Clinical Research, ORION Clinical Services, CIRION Central Laboratory, Dorevitch, Syneos Health
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1. Study Identification

Unique Protocol Identification Number
NCT00358566
Brief Title
GV1001 and Gemcitabine in Sequential Combination to Gemcitabine Monotherapy in Pancreatic Cancer
Official Title
"Primovax" - A Phase III Trial Comparing GV1001 and Gemcitabine in Sequential Combination to Gemcitabine Monotherapy in Advanced Un-Resectable Pancreatic Cancer.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2008
Overall Recruitment Status
Terminated
Why Stopped
Preliminary data showed no survival benefit in the GV1001 group compared to the gemcitabine group.
Study Start Date
June 2006 (undefined)
Primary Completion Date
August 2008 (Anticipated)
Study Completion Date
August 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Pharmexa A/S
Collaborators
ICON Clinical Research, ORION Clinical Services, CIRION Central Laboratory, Dorevitch, Syneos Health

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To investigate the efficacy of GV1001 in sequential combination with gemcitabine in locally advanced and metastatic adenocarcinoma of the pancreas.
Detailed Description
The trial is a Phase III, multinational, multicentre, controlled, randomised open-label trial. It will involve 520 advanced pancreatic cancer patients. Patients will be randomly assigned to receive Gemcitabine alone or GV1001 plus GM-CSF followed by addition of Gemcitabine at the time of 1st progression of disease. The experimental treatment is given prior to the current standard treatment in 50% of the patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Unresectable Pancreatic Cancer
Keywords
Advanced, Unresesctable, Adenocarcinoma, Pancreatic cancer

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Gemcitabine
Arm Type
Active Comparator
Arm Description
Gemcitabine alone treatment.
Arm Title
GV1001
Arm Type
Experimental
Arm Description
GV1001 in sequential combination with Gemcitabine
Intervention Type
Biological
Intervention Name(s)
GV1001
Other Intervention Name(s)
INN-name: Termotide
Intervention Description
0.56mg GV1001 day 1, 3, 5, 8, 15, 22, week 6 and every 4 weeks thereafter. When gemcitabine is add it is given in cycles of once a week for 3 weeks and 1 week. Gemcitabine is dosed as per the SmPC.
Intervention Type
Drug
Intervention Name(s)
Gemcitabine (Chemotherapy)
Other Intervention Name(s)
Gemzar
Intervention Description
Gemcitabine is given as per the Burris regime and the SmPC, i.e. 7 weeks, followed by cycles of 1 weeks rest and 3 weeks chemotherapy.
Primary Outcome Measure Information:
Title
Overall survival time
Time Frame
12 month
Secondary Outcome Measure Information:
Title
Progression Free Survival
Time Frame
Time of progression

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically or cytologically confirmed, unresectable, locally advanced, or metastatic adenocarcinoma of the pancreas. Adequate hematological parameters: Hemoglobin >/= 9.5 g/dL [SI units, 5.9 mmol/L] WBC >/= 3000/mm3 [SI units, >/= 3 x 109/L] Platelets >/= 100,000/mm3 [SI units, >/= 100 x 109/L] Adequate baseline liver function: Total Bilirubin < 3x ULN and Without liver metastases: AST (SGOT) </= 2.5 x ULN ALT (SGPT) </= 2.5 x ULN With liver metastases: AST (SGOT) </= 5 x ULN ALT (SGPT) </= 5 x ULN Serum creatinine </= 1.5 mg/dL [SI units, 132 µmol/L]. Performance status ECOG 0-1. Male or female 18 - 75 years inclusive. Minimum life expectancy of 3 months. Written informed consent. Exclusion Criteria: Treatment with chemotherapy for pancreatic cancer. Treatment with other investigational drugs within the last 4 weeks prior to inclusion Immune-suppressive therapy <4 weeks prior to inclusion Chronic corticosteroid use except for asthma inhalers / topical use Radiotherapy within 8 weeks of randomisation. Other prior malignancies except for adequately treated non-melanoma skin cancers (BCC, SCC) and carcinoma in situ of the cervix. Known diagnosis of HIV (AIDS), Hepatitis B, C. Known history of or co-existing autoimmune disease. Known CNS metastases. Clinically significant serious disease or organ system disease not currently controlled on present therapy. Pregnancy or lactation. Women of childbearing potential not using reliable and adequate contraceptive methods* Known sensitivity to any components of vaccine, gemcitabine or GM-CSF. Unable for any other reason to comply with the protocol (treatment or assessments). Adequate contraceptive methods are defined as the use of oral, implanted, injectable, mechanical or barrier products for the prevention of pregnancy; or women who are practising abstinence; or where the partner is sterile, for example a vasectomy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ask Aabenhus, MSc. (Pharm)
Organizational Affiliation
Pharmexa A/S
Official's Role
Study Director
Facility Information:
Facility Name
University of South Alabama Mitchell Cancer Institute
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36688
Country
United States
Facility Name
Genesis Cancer Center
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
Country
United States
Facility Name
Scripps Clinic Torrey Pines
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Desert Hematology Oncology Medical Group, Inc.
City
Rancho Mirage
State/Province
California
ZIP/Postal Code
92270
Country
United States
Facility Name
The Center for Hematology-Oncology
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
Tampa General Hospital Usf Digestive Disorders Centre
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Palm Beach Cancer Institute
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Facility Name
Portneuf Cancer Center
City
Pocatello
State/Province
Idaho
ZIP/Postal Code
83204
Country
United States
Facility Name
Oncology Hematology Associates of Central Illinois, PC
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61615
Country
United States
Facility Name
Hematology Oncology Specialists, Covington
City
Covington
State/Province
Louisiana
ZIP/Postal Code
70433
Country
United States
Facility Name
Berskhire Hematology Oncology PC
City
Pittsfield
State/Province
Massachusetts
ZIP/Postal Code
01201
Country
United States
Facility Name
Billings Clinic
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
Carolinas Hematology Oncology Associates
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
Gabrail Cancer Center
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Toledo Community Hospital Oncology Program
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43617
Country
United States
Facility Name
Southwest Regional Cancer Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Mary Crowley Medical Research Center (MCMRC)Texas Oncology-Presbyrerian Hospital of Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Mary Crowley Medical Research Center, Worth St.
City
Dallas
State/Province
Texas
ZIP/Postal Code
75249
Country
United States
Facility Name
Oncology Consultants, PA
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Facility Name
St George Hospital, Department of Medical Oncology
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
NSW 2217
Country
Australia
Facility Name
Westmead Hospital, Dept. of Medical Oncology and Palliative Care
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
NSW 2145
Country
Australia
Facility Name
The Townsville Hospital, Townsville Cancer Centre
City
Douglas
State/Province
Queensland
ZIP/Postal Code
QLD 4814
Country
Australia
Facility Name
Flinders Medical Centre, Medical Oncology - Clinical Trials
City
Bedford Park
State/Province
South Australia
ZIP/Postal Code
SA 5042
Country
Australia
Facility Name
Dept. of Clinical Haematology / Oncology,the Queen Elizabeth Hospital
City
Woodville South
State/Province
South Australia
Country
Australia
Facility Name
Royal Hobart Hospital, Centre for Clinical Research
City
Hobart
State/Province
Tasmania
ZIP/Postal Code
TAS 7000
Country
Australia
Facility Name
Box Hill Hospital, ECRU Oncology
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
VIC 3128
Country
Australia
Facility Name
The Alfred Hospital, Medical Oncology Unit
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
VIC 3004
Country
Australia
Facility Name
Fremantle Hospital, Haemtology Department
City
Fremantle
State/Province
Western Australia
ZIP/Postal Code
WA 6160
Country
Australia
Facility Name
Sir Charles Gairdner Hospital
City
Nedlands
State/Province
Western Australia
Country
Australia
Facility Name
Mount Medical Centre, Perth Oncology
City
Perth
State/Province
Western Australia
ZIP/Postal Code
WA 6000
Country
Australia
Facility Name
Royal Perth Hospital, Department of Medical Oncology
City
Perth
State/Province
Western Australia
ZIP/Postal Code
WA 6000
Country
Australia
Facility Name
Wesley Research Institute Limited
City
Auchenflower Qld
Country
Australia
Facility Name
Erasms University Hospital
City
Brussels
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Hospital De Jolimont
City
Bruxelles
ZIP/Postal Code
7100
Country
Belgium
Facility Name
Ghent University Hospital, Digestive Oncology
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Oncology Department, Herlev Hospital
City
Herlev
Country
Denmark
Facility Name
Odense Universitetshospital, Onkologisk afd. R
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Oncology Department, Århus Hospital
City
Århus
Country
Denmark
Facility Name
Centre d'Etudes Cliniques en Oncologie, Centre Paul Papin
City
Angers Cedex 01
ZIP/Postal Code
49933
Country
France
Facility Name
Oncologie Medicale, Clinic Pasteur
City
Evreux
ZIP/Postal Code
27000
Country
France
Facility Name
Hepatogastroenterology Dpt, University Hospital Center of Grenoble
City
Grenoble Cedex
Country
France
Facility Name
Service de Medicine Interne, CHRU de Lille
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Oncologie Midicale CHR Lorient
City
Lorient
ZIP/Postal Code
56100
Country
France
Facility Name
Hôpital de la Roche / Yon <<Les Oudaires>>, Centre Hospitalier Départmentale
City
Moreau
ZIP/Postal Code
85925
Country
France
Facility Name
Oncologie Médicale, Centre Cathrine de Siennes
City
Nantes
ZIP/Postal Code
44200
Country
France
Facility Name
Service de Cancerologie, Hospital Europeen Georges Pompidou
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Medical Oncology Dpt, Armoricaine Private Hospital of Radiology
City
Saint Brieuc
Country
France
Facility Name
Clinic Saint Vincent
City
Saint Gregoire
ZIP/Postal Code
35760
Country
France
Facility Name
Oncology Trials Unit, Cork University Hospital
City
Cork
Country
Ireland
Facility Name
Cancer Clinical Trials Unit, Beaumont Hospital
City
Dublin
Country
Ireland
Facility Name
Cancer Research Unit, Mater Misericordlae University Hospital
City
Dublin
Country
Ireland
Facility Name
Department of Medical Oncology, Amnch
City
Dublin
Country
Ireland
Facility Name
Oncology Research Team, Mater Private University Hospital
City
Dublin
Country
Ireland
Facility Name
Medical Oncology, University "Politecnica Delle Marche", Oncologia Medica Universita
City
Ancona
ZIP/Postal Code
60100
Country
Italy
Facility Name
Policlinico Universitario "Mater Domini", Unita Oncologia
City
Catanzaro
ZIP/Postal Code
88100
Country
Italy
Facility Name
Hospital "Careggi", Medical Oncology
City
Firenze
ZIP/Postal Code
50139
Country
Italy
Facility Name
Azienda Ospedaliera, Arcispedale S. Maria Nuova
City
Reggio Emilia
ZIP/Postal Code
42100
Country
Italy
Facility Name
Hospital "G.B. Rossi", Surgical and Gastroenterological Dept. Borgo Roma
City
Verona
ZIP/Postal Code
37134
Country
Italy
Facility Name
VU University Medical Center
City
Amsterdam
ZIP/Postal Code
1081 HV
Country
Netherlands
Facility Name
Department of Oncology, Haukeland University Hospital, G.I. & Urogenital Oncology
City
Bergen
Country
Norway
Facility Name
Sorlandet Hospital, Senter for Kreftbehandling
City
Kristiansand
ZIP/Postal Code
4604
Country
Norway
Facility Name
Ullevål Universitetssykehus, Gastrokirurgisk afd.
City
Oslo
ZIP/Postal Code
0407
Country
Norway
Facility Name
Department of Oncology, University Hospital of Northern-Norway
City
Tromsoe
Country
Norway
Facility Name
Bialstocki Osrodek Onkologiczny, Oddzial Chemioterapii Nowotworow I Chorob Wewnetrznych
City
Bialystok
ZIP/Postal Code
15-027
Country
Poland
Facility Name
W.S2.Z, Krolewiecka
City
Elblag
ZIP/Postal Code
82-300
Country
Poland
Facility Name
Wojewodzki Szpital Specjalistyczny im.Rydgiera, Oddzial Chemioterapii
City
Krakow
ZIP/Postal Code
31-826
Country
Poland
Facility Name
Klinika Chemioterapii Uniwersytetu Medycznego w Lodzi, Medical University
City
Lodz
Country
Poland
Facility Name
Zaklad Opieki Zdrowotnej MSWiA
City
Olsztyn
ZIP/Postal Code
10-228
Country
Poland
Facility Name
Centrum Onkologii, Wosewodzki Osrodek Onkologii
City
Opole
ZIP/Postal Code
45-060
Country
Poland
Facility Name
Dolnoslaskie Centrum Onkologii, Oddzial Chemioterapii
City
Wroclaw
ZIP/Postal Code
53-143
Country
Poland
Facility Name
Hospital Clinic I Provincial De Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Medical Oncology Department, General Hospital of Baza
City
Granada
Country
Spain
Facility Name
Medical Oncology Department, Virgen de Las Nieves Hospital
City
Granada
Country
Spain
Facility Name
Hospital Universitario Gregorio Marañón, Departamento de Oncología
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Clínica Puerta de Hierro, Departamento de Oncología
City
Madrid
ZIP/Postal Code
28035
Country
Spain
Facility Name
Hospital Universitario La Paz, Departamento de Oncología
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
H. Monteprincipe
City
Madrid
ZIP/Postal Code
28660
Country
Spain
Facility Name
Fundaciόn Hospital de Alcorcόn, Unidad de Oncología
City
Madrid
ZIP/Postal Code
28922
Country
Spain
Facility Name
HRU Carlos Haya, Medical Oncology Unit
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Oncology Department, Clinic Universitary Hospital
City
Malaga
Country
Spain
Facility Name
Digestive Unit, Universitary Hospital Virgen de La Macarena
City
Seville
Country
Spain
Facility Name
Sahlgrenska Hospital, Head Division for Upper GI Surgery
City
Goteborg
ZIP/Postal Code
413 45
Country
Sweden
Facility Name
University Hospital, Department Of surgery and Gasterenterology
City
Lund
ZIP/Postal Code
221 85
Country
Sweden
Facility Name
Department of Oncology, Malmö University Hospital
City
Malmö
Country
Sweden
Facility Name
Karolinska Institute / Hospital Solna, Department of Oncology
City
Stockholm
ZIP/Postal Code
171 76
Country
Sweden
Facility Name
Department of Oncology, Karolinska Universitetssjukhuset
City
Stockholm
ZIP/Postal Code
SE- 171 76
Country
Sweden

12. IPD Sharing Statement

Learn more about this trial

GV1001 and Gemcitabine in Sequential Combination to Gemcitabine Monotherapy in Pancreatic Cancer

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