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

This study has been terminated.
(Preliminary data showed no survival benefit in the GV1001 group compared to the gemcitabine group.)
Sponsor:
Collaborators:
ICON Clinical Research
ORION Clinical Services
CIRION Central Laboratory
Dorevitch
INC Research
Information provided by:
Pharmexa A/S
ClinicalTrials.gov Identifier:
NCT00358566
First received: July 14, 2006
Last updated: May 16, 2008
Last verified: May 2008
  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 3

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


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
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
INC Research
Investigators
Study Director: Ask Aabenhus, MSc. (Pharm) Pharmexa A/S
  More Information

No publications provided

Responsible Party: Ask Aabenhus, Clinical Trial Manager, Pharmexa A/S
ClinicalTrials.gov Identifier: NCT00358566     History of Changes
Other Study ID Numbers: PX115.1.1-302, Eudract no. 2005-005014-21
Study First Received: July 14, 2006
Last Updated: May 16, 2008
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
United States: Food and Drug Administration
Denmark: Danish Medicines Agency
Denmark: Ethics Committee

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

Additional relevant MeSH terms:
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
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on July 24, 2014