E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10033633 |
|
E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To investigate the efficacy of GV1001 in sequential combination with gemcitabine in locally advanced or metastatic adenocarcinoma of the pancreas. |
|
E.2.2 | Secondary objectives of the trial |
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. |
|
E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Title: “Primovax” – A Phase III Trial Comparing GV1001 and Gemcitabine in Sequential Combination to Gemcitabine Monotherapy in Advanced Un-resectable Pancreatic Cancer.
Version and date: Final Version 1.0; 9 January 2006
Related objective: The pharmacoeconomics in relation to treatment with GV1001 in locally advanced or metastatic adenocarcinoma of the pancreas (evaluation will be undertaken in France only) |
|
E.3 | Principal 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. |
|
E.4 | Principal 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). |
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E.5 End points |
E.5.1 | Primary end point(s) |
Overall survival defined as time from randomisation until death. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | Yes |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
|
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 40 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
|
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
The trial will stop 12 months after inclusion of the last patient. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |