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

May 16, 2008 updated by: Pharmexa A/S

"Primovax" - A Phase III Trial Comparing GV1001 and Gemcitabine in Sequential Combination to Gemcitabine Monotherapy in Advanced Un-Resectable Pancreatic Cancer.

To investigate the efficacy of GV1001 in sequential combination with gemcitabine in locally advanced and metastatic adenocarcinoma of the pancreas.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

360

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Auchenflower Qld, Australia
        • Wesley Research Institute Limited
    • New South Wales
      • Kogarah, New South Wales, Australia, NSW 2217
        • St George Hospital, Department of Medical Oncology
      • Westmead, New South Wales, Australia, NSW 2145
        • Westmead Hospital, Dept. of Medical Oncology and Palliative Care
    • Queensland
      • Douglas, Queensland, Australia, QLD 4814
        • The Townsville Hospital, Townsville Cancer Centre
    • South Australia
      • Bedford Park, South Australia, Australia, SA 5042
        • Flinders Medical Centre, Medical Oncology - Clinical Trials
      • Woodville South, South Australia, Australia
        • Dept. of Clinical Haematology / Oncology,the Queen Elizabeth Hospital
    • Tasmania
      • Hobart, Tasmania, Australia, TAS 7000
        • Royal Hobart Hospital, Centre for Clinical Research
    • Victoria
      • Box Hill, Victoria, Australia, VIC 3128
        • Box Hill Hospital, ECRU Oncology
      • Melbourne, Victoria, Australia, VIC 3004
        • The Alfred Hospital, Medical Oncology Unit
    • Western Australia
      • Fremantle, Western Australia, Australia, WA 6160
        • Fremantle Hospital, Haemtology Department
      • Nedlands, Western Australia, Australia
        • Sir Charles Gairdner Hospital
      • Perth, Western Australia, Australia, WA 6000
        • Mount Medical Centre, Perth Oncology
      • Perth, Western Australia, Australia, WA 6000
        • Royal Perth Hospital, Department of Medical Oncology
  • Belgium
      • Brussels, Belgium, 1070
        • Erasms University Hospital
      • Bruxelles, Belgium, 7100
        • Hospital de Jolimont
      • Ghent, Belgium, 9000
        • Ghent University Hospital, Digestive Oncology
  • Denmark
      • Herlev, Denmark
        • Oncology Department, Herlev Hospital
      • Odense, Denmark, 5000
        • Odense Universitetshospital, Onkologisk afd. R
      • Århus, Denmark
        • Oncology Department, Århus Hospital
  • France
      • Angers Cedex 01, France, 49933
        • Centre d'Etudes Cliniques en Oncologie, Centre Paul Papin
      • Evreux, France, 27000
        • Oncologie Medicale, Clinic Pasteur
      • Grenoble Cedex, France
        • Hepatogastroenterology Dpt, University Hospital Center of Grenoble
      • Lille, France, 59037
        • Service de Medicine Interne, CHRU de Lille
      • Lorient, France, 56100
        • Oncologie Midicale CHR Lorient
      • Moreau, France, 85925
        • Hôpital de la Roche / Yon <<Les Oudaires>>, Centre Hospitalier Départmentale
      • Nantes, France, 44200
        • Oncologie Médicale, Centre Cathrine de Siennes
      • Paris, France, 75015
        • Service de Cancerologie, Hospital Europeen Georges Pompidou
      • Saint Brieuc, France
        • Medical Oncology Dpt, Armoricaine Private Hospital of Radiology
      • Saint Gregoire, France, 35760
        • Clinic Saint Vincent
  • Ireland
      • Cork, Ireland
        • Oncology Trials Unit, Cork University Hospital
      • Dublin, Ireland
        • Cancer Clinical Trials Unit, Beaumont Hospital
      • Dublin, Ireland
        • Cancer Research Unit, Mater Misericordlae University Hospital
      • Dublin, Ireland
        • Department of Medical Oncology, Amnch
      • Dublin, Ireland
        • Oncology Research Team, Mater Private University Hospital
  • Italy
      • Ancona, Italy, 60100
        • Medical Oncology, University "Politecnica Delle Marche", Oncologia Medica Universita
      • Catanzaro, Italy, 88100
        • Policlinico Universitario "Mater Domini", Unita Oncologia
      • Firenze, Italy, 50139
        • Hospital "Careggi", Medical Oncology
      • Reggio Emilia, Italy, 42100
        • Azienda Ospedaliera, Arcispedale S. Maria Nuova
      • Verona, Italy, 37134
        • Hospital "G.B. Rossi", Surgical and Gastroenterological Dept. Borgo Roma
  • Netherlands
      • Amsterdam, Netherlands, 1081 HV
        • VU University Medical Center
  • Norway
      • Bergen, Norway
        • Department of Oncology, Haukeland University Hospital, G.I. & Urogenital Oncology
      • Kristiansand, Norway, 4604
        • Sorlandet Hospital, Senter for Kreftbehandling
      • Oslo, Norway, 0407
        • Ullevål Universitetssykehus, Gastrokirurgisk afd.
      • Tromsoe, Norway
        • Department of Oncology, University Hospital of Northern-Norway
  • Poland
      • Bialystok, Poland, 15-027
        • Bialstocki Osrodek Onkologiczny, Oddzial Chemioterapii Nowotworow I Chorob Wewnetrznych
      • Elblag, Poland, 82-300
        • W.S2.Z, Krolewiecka
      • Krakow, Poland, 31-826
        • Wojewodzki Szpital Specjalistyczny im.Rydgiera, Oddzial Chemioterapii
      • Lodz, Poland
        • Klinika Chemioterapii Uniwersytetu Medycznego w Lodzi, Medical University
      • Olsztyn, Poland, 10-228
        • Zaklad Opieki Zdrowotnej MSWiA
      • Opole, Poland, 45-060
        • Centrum Onkologii, Wosewodzki Osrodek Onkologii
      • Wroclaw, Poland, 53-143
        • Dolnoslaskie Centrum Onkologii, Oddzial Chemioterapii
  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinic i Provincial de Barcelona
      • Granada, Spain
        • Medical Oncology Department, General Hospital of Baza
      • Granada, Spain
        • Medical Oncology Department, Virgen de Las Nieves Hospital
      • Madrid, Spain, 28007
        • Hospital Universitario Gregorio Marañón, Departamento de Oncología
      • Madrid, Spain, 28035
        • Clínica Puerta de Hierro, Departamento de Oncología
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz, Departamento de Oncología
      • Madrid, Spain, 28660
        • H. Monteprincipe
      • Madrid, Spain, 28922
        • Fundaciόn Hospital de Alcorcόn, Unidad de Oncología
      • Malaga, Spain, 29010
        • HRU Carlos Haya, Medical Oncology Unit
      • Malaga, Spain
        • Oncology Department, Clinic Universitary Hospital
      • Seville, Spain
        • Digestive Unit, Universitary Hospital Virgen de La Macarena
  • Sweden
      • Goteborg, Sweden, 413 45
        • Sahlgrenska Hospital, Head Division for Upper GI Surgery
      • Lund, Sweden, 221 85
        • University Hospital, Department Of surgery and Gasterenterology
      • Malmö, Sweden
        • Department of Oncology, Malmö University Hospital
      • Stockholm, Sweden, 171 76
        • Karolinska Institute / Hospital Solna, Department of Oncology
      • Stockholm, Sweden, SE- 171 76
        • Department of Oncology, Karolinska Universitetssjukhuset
  • United States
    • Alabama
      • Mobile, Alabama, United States, 36688
        • University of South Alabama Mitchell Cancer Institute
    • Arkansas
      • Hot Springs, Arkansas, United States, 71913
        • Genesis Cancer Center
    • California
      • La Jolla, California, United States, 92037
        • Scripps Clinic Torrey Pines
      • Rancho Mirage, California, United States, 92270
        • Desert Hematology Oncology Medical Group, Inc.
    • Florida
      • Boca Raton, Florida, United States, 33486
        • The Center for Hematology-Oncology
      • Tampa, Florida, United States, 33606
        • Tampa General Hospital Usf Digestive Disorders Centre
      • West Palm Beach, Florida, United States, 33401
        • Palm Beach Cancer Institute
    • Idaho
      • Pocatello, Idaho, United States, 83204
        • Portneuf Cancer Center
    • Illinois
      • Peoria, Illinois, United States, 61615
        • Oncology Hematology Associates of Central Illinois, PC
    • Louisiana
      • Covington, Louisiana, United States, 70433
        • Hematology Oncology Specialists, Covington
    • Massachusetts
      • Pittsfield, Massachusetts, United States, 01201
        • Berskhire Hematology Oncology PC
    • Montana
      • Billings, Montana, United States, 59101
        • Billings Clinic
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • Carolinas Hematology Oncology Associates
    • Ohio
      • Canton, Ohio, United States, 44718
        • Gabrail Cancer Center
      • Toledo, Ohio, United States, 43617
        • Toledo Community Hospital Oncology Program
    • Texas
      • Austin, Texas, United States, 78705
        • Southwest Regional Cancer Center
      • Dallas, Texas, United States, 75231
        • Mary Crowley Medical Research Center (MCMRC)Texas Oncology-Presbyrerian Hospital of Dallas
      • Dallas, Texas, United States, 75249
        • Mary Crowley Medical Research Center, Worth St.
      • Houston, Texas, United States, 77024
        • Oncology Consultants, PA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Histologically or cytologically confirmed, unresectable, locally advanced, or metastatic adenocarcinoma of the pancreas.

  2. 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]

  3. 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

  4. Serum creatinine </= 1.5 mg/dL [SI units, 132 µmol/L].
  5. Performance status ECOG 0-1.
  6. Male or female 18 - 75 years inclusive.
  7. Minimum life expectancy of 3 months.
  8. Written informed consent.

Exclusion Criteria:

  1. Treatment with chemotherapy for pancreatic cancer.
  2. Treatment with other investigational drugs within the last 4 weeks prior to inclusion
  3. Immune-suppressive therapy <4 weeks prior to inclusion
  4. Chronic corticosteroid use except for asthma inhalers / topical use
  5. Radiotherapy within 8 weeks of randomisation.
  6. Other prior malignancies except for adequately treated non-melanoma skin cancers (BCC, SCC) and carcinoma in situ of the cervix.
  7. Known diagnosis of HIV (AIDS), Hepatitis B, C.
  8. Known history of or co-existing autoimmune disease.
  9. Known CNS metastases.
  10. Clinically significant serious disease or organ system disease not currently controlled on present therapy.
  11. Pregnancy or lactation.
  12. Women of childbearing potential not using reliable and adequate contraceptive methods*
  13. Known sensitivity to any components of vaccine, gemcitabine or GM-CSF.

  14. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Gemcitabine
Gemcitabine alone treatment.
Drug: Gemcitabine (Chemotherapy)
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.
Other Names:
  • Gemzar
EXPERIMENTAL: GV1001
GV1001 in sequential combination with Gemcitabine
Biological: GV1001
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.
Other Names:
  • INN-name: Termotide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall survival time
Time Frame: 12 month
12 month

Secondary Outcome Measures

Outcome Measure
Time Frame
Progression Free Survival
Time Frame: Time of progression
Time of progression

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pharmexa A/S

Collaborators

Syneos Health
ICON Clinical Research
ORION Clinical Services
CIRION Central Laboratory
Dorevitch

Investigators

  • Study Director: Ask Aabenhus, MSc. (Pharm), Pharmexa A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Primary Completion (ANTICIPATED)

August 1, 2008

Study Completion (ANTICIPATED)

August 1, 2008

Study Registration Dates

First Submitted

July 14, 2006

First Submitted That Met QC Criteria

July 31, 2006

First Posted (ESTIMATE)

August 1, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

May 19, 2008

Last Update Submitted That Met QC Criteria

May 16, 2008

Last Verified

May 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PX115.1.1-302
  • Eudract no. 2005-005014-21

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe