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GV1001 and Gemcitabine in Sequential Combination to Gemcitabine Monotherapy in Pancreatic Cancer
This study has been terminated.
Sponsors and Collaborators: Pharmexa A/S
ICON Clinical Research
ORION Clinical Services
CIRION Central Laboratory
Dorevitch
Kendle International
Information provided by: Pharmexa A/S
ClinicalTrials.gov Identifier: NCT00358566
  Purpose

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


Condition Intervention Phase
Advanced Unresectable Pancreatic Cancer
Biological: GV1001
Drug: Gemcitabine (Chemotherapy)
Phase III

MedlinePlus related topics: Cancer Pancreatic Cancer
Drug Information available for: Gemcitabine hydrochloride Gemcitabine
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: "Primovax" - A Phase III Trial Comparing GV1001 and Gemcitabine in Sequential Combination to Gemcitabine Monotherapy in Advanced Un-Resectable Pancreatic Cancer.

Further study details as provided by Pharmexa A/S:

Primary Outcome Measures:
  • Overall survival time [ Time Frame: 12 month ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Progression Free Survival [ Time Frame: Time of progression ] [ Designated as safety issue: Yes ]

Enrollment: 360
Study Start Date: June 2006
Estimated Study Completion Date: August 2008
Estimated Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Gemcitabine: Active Comparator
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.
GV1001: Experimental
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00358566

  Show 86 Study Locations
Sponsors and Collaborators
Pharmexa A/S
ICON Clinical Research
ORION Clinical Services
CIRION Central Laboratory
Dorevitch
Kendle International
Investigators
Study Director: Ask Aabenhus, MSc. (Pharm) Pharmexa A/S
  More Information

Responsible Party: Pharmexa A/S ( Ask Aabenhus, Clinical Trial Manager )
Study ID Numbers: PX115.1.1-302, Eudract no. 2005-005014-21
Study First Received: July 14, 2006
Last Updated: May 16, 2008
ClinicalTrials.gov Identifier: NCT00358566  
Health Authority: France: Afssaps - French Health Products Safety Agency;   United States: Food and Drug Administration;   Denmark: Danish Medicines Agency;   Denmark: Ethics Committee

Keywords provided by Pharmexa A/S:
Advanced
Unresesctable
Adenocarcinoma
Pancreatic cancer

Study placed in the following topic categories:
Digestive System Diseases
Digestive System Neoplasms
Pancreatic Neoplasms
Endocrine System Diseases
Pancreatic Diseases
Gastrointestinal Neoplasms
Endocrinopathy
Gemcitabine
Adenocarcinoma
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on January 16, 2009