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Study 3 of 529 for search of: | Australia, Western Australia |
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Sponsors and Collaborators: |
Pharmexa A/S ICON Clinical Research ORION Clinical Services CIRION Central Laboratory Dorevitch Kendle International |
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Information provided by: | Pharmexa A/S |
ClinicalTrials.gov Identifier: | NCT00358566 |
To investigate the efficacy of GV1001 in sequential combination with gemcitabine in locally advanced and metastatic adenocarcinoma of the pancreas.
Condition | Intervention | Phase |
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Advanced Unresectable Pancreatic Cancer |
Biological: GV1001 Drug: Gemcitabine (Chemotherapy) |
Phase III |
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. |
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 |
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Gemcitabine: Active Comparator
Gemcitabine alone treatment.
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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.
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GV1001: Experimental
GV1001 in sequential combination with Gemcitabine
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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.
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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.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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]
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
Exclusion Criteria:
Unable for any other reason to comply with the protocol (treatment or assessments).
Study Director: | Ask Aabenhus, MSc. (Pharm) | Pharmexa A/S |
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 |
Advanced Unresesctable Adenocarcinoma Pancreatic cancer |
Digestive System Diseases Digestive System Neoplasms Pancreatic Neoplasms Endocrine System Diseases Pancreatic Diseases |
Gastrointestinal Neoplasms Endocrinopathy Gemcitabine Adenocarcinoma Endocrine Gland Neoplasms |
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 |