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

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ClinicalTrials.gov Identifier: NCT00358566
Recruitment Status : Terminated (Preliminary data showed no survival benefit in the GV1001 group compared to the gemcitabine group.)
First Posted : August 1, 2006
Last Update Posted : May 19, 2008
Sponsor:
Collaborators:
ICON Clinical Research
ORION Clinical Services
CIRION Central Laboratory
Dorevitch
Syneos Health
Information provided by:
Pharmexa A/S

Study Description
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Brief Summary:
To investigate the efficacy of GV1001 in sequential combination with gemcitabine in locally advanced and metastatic adenocarcinoma of the pancreas.

Condition or disease Intervention/treatment Phase
Advanced Unresectable Pancreatic Cancer Biological: GV1001 Drug: Gemcitabine (Chemotherapy) Phase 3

Expanded Access : Pharmexa A/S has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.  

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: "Primovax" - A Phase III Trial Comparing GV1001 and Gemcitabine in Sequential Combination to Gemcitabine Monotherapy in Advanced Un-Resectable Pancreatic Cancer.
Study Start Date : June 2006
Estimated Primary Completion Date : August 2008
Estimated Study Completion Date : August 2008

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Arms and Interventions
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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 Name: 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 Name: INN-name: Termotide


Outcome Measures
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Primary Outcome Measures :
  1. Overall survival time [ Time Frame: 12 month ]

Secondary Outcome Measures :
  1. Progression Free Survival [ Time Frame: Time of progression ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00358566


Locations
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Sponsors and Collaborators
Pharmexa A/S
ICON Clinical Research
ORION Clinical Services
CIRION Central Laboratory
Dorevitch
Syneos Health
Investigators
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Study Director: Ask Aabenhus, MSc. (Pharm) Pharmexa A/S
More Information
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Responsible Party: Ask Aabenhus, Clinical Trial Manager, Pharmexa A/S
ClinicalTrials.gov Identifier: NCT00358566    
Other Study ID Numbers: PX115.1.1-302
Eudract no. 2005-005014-21
First Posted: August 1, 2006    Key Record Dates
Last Update Posted: May 19, 2008
Last Verified: May 2008
Keywords provided by Pharmexa A/S:
Advanced
Unresesctable
Adenocarcinoma
Pancreatic cancer
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Antimetabolites, Antineoplastic
 Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs