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

Conditions: Pancreatic Cancer
MedDRA version: 8.0Level: LLTClassification code 10033633

Registration Number: EUCTR2005-005014-21-IE

Lead Sponsor: Pharmexa A/S

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 520

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).

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate the efficacy of GV1001 in sequential combination with gemcitabine in locally advanced or metastatic adenocarcinoma of the pancreas.;Secondary Objective: To evaluate:<br>- the safety of GV1001 alone and in combination with gemcitabine in locally advanced or metastatic adenocarcinoma of the pancreas.<br>- the efficacy of GV1001 used as monotherapy in locally advanced or metastatic adenocarcinoma of the pancreas.<br>- the immunogenicity of GV1001 alone and in combination with gemcitabine in locally advanced or metastatic adenocarcinoma of the pancreas.<br>- the pharmacoeconomics in relation to treatment with GV1001 in locally advanced or metastatic adenocarcinoma of the pancreas<br><br> Pharmacoeconomics evaluation will be undertaken in France only.;Primary end point(s): Overall survival defined as time from randomisation until death.

Secondary Outcome Measures