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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00358566
• Date of registration: 14/07/2006
• Prospective Registration: No
• Primary sponsor: Pharmexa A/S
• Public title: GV1001 and Gemcitabine in Sequential Combination to Gemcitabine Monotherapy in Pancreatic Cancer
• Scientific title: "Primovax" - A Phase III Trial Comparing GV1001 and Gemcitabine in Sequential Combination to Gemcitabine Monotherapy in Advanced Un-Resectable Pancreatic Cancer.
• Date of first enrolment: June 2006
• Target sample size: 360
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT00358566
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Australia, Belgium, Denmark, France, Germany, Ireland, Italy, Netherlands, Norway, Poland, Spain, Sweden, United States

Contacts

• Name: Ask Aabenhus, MSc. (Pharm)
• Affiliation: Pharmexa A/S

Key inclusion & exclusion 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)
With liver metastases:

AST (SGOT)
4. Serum creatinine
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.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Advanced Unresectable Pancreatic Cancer

Intervention(s)

Biological: GV1001

Drug: Gemcitabine (Chemotherapy)

Primary Outcome(s)

Overall survival time [Time Frame: 12 month]

Secondary Outcome(s)

Progression Free Survival [Time Frame: Time of progression]

Secondary ID(s)

Eudract no. 2005-005014-21

PX115.1.1-302

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

CIRION Central Laboratory

ORION Clinical Services

Dorevitch

ICON Clinical Research

INC Research