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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00358566




Registration number
NCT00358566
Ethics application status
Date submitted
14/07/2006
Date registered
1/08/2006
Date last updated
19/05/2008

Titles & IDs
Public title
GV1001 and Gemcitabine in Sequential Combination to Gemcitabine Monotherapy in Pancreatic Cancer
Scientific title
"Primovax" - A Phase III Trial Comparing GV1001 and Gemcitabine in Sequential Combination to Gemcitabine Monotherapy in Advanced Un-Resectable Pancreatic Cancer.
Secondary ID [1] 0 0
Eudract no. 2005-005014-21
Secondary ID [2] 0 0
PX115.1.1-302
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Unresectable Pancreatic Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Pancreatic

Intervention/exposure
Study type
Interventional(has expanded access)
Description of intervention(s) / exposure
Other interventions - GV1001
Treatment: Drugs - Gemcitabine (Chemotherapy)

Active Comparator: Gemcitabine - Gemcitabine alone treatment.

Experimental: GV1001 - GV1001 in sequential combination with Gemcitabine


Other interventions: 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.

Treatment: Drugs: 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.
Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall survival time
Timepoint [1] 0 0
12 month
Secondary outcome [1] 0 0
Progression Free Survival
Timepoint [1] 0 0
Time of progression

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/08/2008
Actual
Sample size
Target
Accrual to date
Final
360
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
St George Hospital, Department of Medical Oncology - Kogarah
Recruitment hospital [2] 0 0
Westmead Hospital, Dept. of Medical Oncology and Palliative Care - Westmead
Recruitment hospital [3] 0 0
The Townsville Hospital, Townsville Cancer Centre - Douglas
Recruitment hospital [4] 0 0
Flinders Medical Centre, Medical Oncology - Clinical Trials - Bedford Park
Recruitment hospital [5] 0 0
Dept. of Clinical Haematology / Oncology,the Queen Elizabeth Hospital - Woodville South
Recruitment hospital [6] 0 0
Royal Hobart Hospital, Centre for Clinical Research - Hobart
Recruitment hospital [7] 0 0
Box Hill Hospital, ECRU Oncology - Box Hill
Recruitment hospital [8] 0 0
The Alfred Hospital, Medical Oncology Unit - Melbourne
Recruitment hospital [9] 0 0
Fremantle Hospital, Haemtology Department - Fremantle
Recruitment hospital [10] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [11] 0 0
Mount Medical Centre, Perth Oncology - Perth
Recruitment hospital [12] 0 0
Royal Perth Hospital, Department of Medical Oncology - Perth
Recruitment hospital [13] 0 0
Wesley Research Institute Limited - Auchenflower Qld
Recruitment postcode(s) [1] 0 0
NSW 2217 - Kogarah
Recruitment postcode(s) [2] 0 0
NSW 2145 - Westmead
Recruitment postcode(s) [3] 0 0
QLD 4814 - Douglas
Recruitment postcode(s) [4] 0 0
SA 5042 - Bedford Park
Recruitment postcode(s) [5] 0 0
- Woodville South
Recruitment postcode(s) [6] 0 0
TAS 7000 - Hobart
Recruitment postcode(s) [7] 0 0
VIC 3128 - Box Hill
Recruitment postcode(s) [8] 0 0
VIC 3004 - Melbourne
Recruitment postcode(s) [9] 0 0
WA 6160 - Fremantle
Recruitment postcode(s) [10] 0 0
- Nedlands
Recruitment postcode(s) [11] 0 0
WA 6000 - Perth
Recruitment postcode(s) [12] 0 0
- Auchenflower Qld
Recruitment outside Australia
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United States of America
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Alabama
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Arkansas
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California
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Florida
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Idaho
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Illinois
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Louisiana
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Massachusetts
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Montana
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North Carolina
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Ohio
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United States of America
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Texas
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Belgium
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Brussels
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Belgium
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Bruxelles
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Belgium
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Ghent
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Denmark
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Herlev
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Denmark
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Odense
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Denmark
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Århus
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France
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Angers Cedex 01
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France
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Evreux
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France
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Grenoble Cedex
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France
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Lille
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France
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Lorient
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France
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Moreau
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France
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Nantes
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France
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Paris
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France
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Saint Brieuc
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France
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Saint Gregoire
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Ireland
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Cork
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Ireland
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Dublin
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Italy
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Ancona
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Italy
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Catanzaro
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Italy
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Firenze
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Italy
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Reggio Emilia
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Italy
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Verona
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Netherlands
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Amsterdam
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Bergen
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Norway
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Kristiansand
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Norway
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Oslo
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Norway
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Tromsoe
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Poland
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Bialystok
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Elblag
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Krakow
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Lodz
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Olsztyn
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Opole
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Wroclaw
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Barcelona
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Granada
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Madrid
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Malaga
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Seville
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Sweden
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Goteborg
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Sweden
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Lund
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Sweden
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Malmö
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Sweden
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Stockholm

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Pharmexa A/S
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
ICON Clinical Research
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/Industry
Name [2] 0 0
ORION Clinical Services
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
CIRION Central Laboratory
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Dorevitch
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
Syneos Health
Address [5] 0 0
Country [5] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
To investigate the efficacy of GV1001 in sequential combination with gemcitabine in locally
advanced and metastatic adenocarcinoma of the pancreas.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00358566
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ask Aabenhus, MSc. (Pharm)
Address 0 0
Pharmexa A/S
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00358566