Advanced Unresectable Pancreatic Cancer
Conditions
Keywords
Advanced, Unresesctable, Adenocarcinoma, Pancreatic cancer
Brief summary
To investigate the efficacy of GV1001 in sequential combination with gemcitabine in locally advanced and metastatic adenocarcinoma of the pancreas.
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.
Interventions
BIOLOGICALGV1001
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.
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.
Sponsors
ICON Clinical Research
ORION Clinical Services
CIRION Central Laboratory
Dorevitch
Syneos Health
Pharmexa A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival time | 12 month |
Secondary
| Measure | Time frame |
|---|---|
| Progression Free Survival | Time of progression |
Countries
Australia, Belgium, Denmark, France, Ireland, Italy, Netherlands, Norway, Poland, Spain, Sweden, United States
Outcome results
None listed