“Primovax” – A Phase III Trial Comparing GV1001 and Gemcitabine in Sequential Combination to Gemcitabine Monotherapy in Advanced Un-resectable Pancreatic Cancer.

• Register: EUCTR
• Last refreshed on: 7 October 2014
• Main ID: EUCTR2005-005014-21-BE
• Date of registration: 28/03/2006
• Prospective Registration: Yes
• Primary sponsor: Pharmexa A/S
• Public title: “Primovax” – A Phase III Trial Comparing GV1001 and Gemcitabine in Sequential Combination to Gemcitabine Monotherapy in Advanced Un-resectable 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: 25/07/2006
• Target sample size: 520
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-005014-21
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no

Countries of recruitment

Belgium, Denmark, Ireland, Norway, Spain, Sweden

Key inclusion & exclusion criteria

Inclusion criteria:
1. Histologically or cytologically confirmed, unresectable, locally advanced, or metastatic adenocarcinoma of the pancreas.
2. Adequate haematological parameters.
3. Adequate baseline liver functions.
4. Serum creatinine equal to or less than 1.5 mg/dL
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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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).


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Pancreatic Cancer
MedDRA version: 8.0 Level: LLT Classification code 10033633

Intervention(s)

Product Name: GV1001
Product Code: PX115-1
Pharmaceutical Form: Powder for injection*
Current Sponsor code: A001
Other descriptive name: SF375
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 0.756-0.924

Trade Name: Leukine®
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Sargramostim
Other descriptive name: Leukine
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 250-

Primary Outcome(s)

Main Objective: To investigate the efficacy of GV1001 in sequential combination with gemcitabine in locally advanced or metastatic adenocarcinoma of the pancreas.

Primary end point(s): Overall survival defined as time from randomisation until death.

Secondary Objective: To evaluate:
- the safety of GV1001 alone and in combination with gemcitabine in locally advanced or metastatic adenocarcinoma of the pancreas.
- the efficacy of GV1001 used as monotherapy in locally advanced or metastatic adenocarcinoma of the pancreas.
- the immunogenicity of GV1001 alone and in combination with gemcitabine in locally advanced or metastatic adenocarcinoma of the pancreas.
- the pharmacoeconomics in relation to treatment with GV1001 in locally advanced or metastatic adenocarcinoma of the pancreas*

* Pharmacoeconomics evaluation will be undertaken in France only.

Secondary ID(s)

2005-005014-21-IE

PX115.1.1-302