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 | 16.1 |
E.1.2 | Level | HLT |
E.1.2 | Classification code | 10033633 |
E.1.2 | Term | Pancreatic neoplasms malignant (excl islet cell and carcinoid) |
E.1.2 | System Organ Class | 100000004864 |
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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 on length of survival when added concurrently or sequentially to the combination gemcitabine and capecitabine in patients with locally advanced or metastatic pancreatic adenocarcinoma. |
|
E.2.2 | Secondary objectives of the trial |
To investigate the safety of GV1001 when added concurrently or sequentially to the combination gemcitabine and capecitabine in patients with locally advanced or metastatic pancreatic adenocarcinoma.To evaluate the immunogenicity of GV1001 when added concurrently or sequentially to the combination gemcitabine and capecitabine in patients with locally advanced or metastatic pancreatic adenocarcinoma. Specifically: 1. time to progression 2. quality of life 3. clinical benefit response 4. objective response rate 5. toxicity 6. survival and response by DTH 7. CA 19-9 over time |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Age > 18 years. 2. Histologically or cytologically proven pancreatic ductal adenocarcinoma carcinoma or undifferentiated carcinoma of the pancreas. 3. Locally advanced or metastatic disease precluding curative surgical resection. 4. Contrast enhanced CT scan of the thorax, abdomen and pelvis within 28 days prior to commencing treatment. 5. Unidimensionally measurable disease (CT) in accordance with the RECIST guidelines. 6. ECOG performance status 0, 1 or 2. 7. Platelets >100 x 109/l; WBC > 3 x 109/l; neutrophils > 1.5 x 109/l at entry. 8.Serum Bilirubin <35 micromol/l 9. Calculated creatinine clearance over 50ml/min according to Cockcroft & Gault. 10. Life expectancy > 3 months. 11. Informed written consent. |
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E.4 | Principal exclusion criteria |
1. Medical or psychiatric conditions compromising informed consent. 2. Intracerebral metastases or meningeal carcinomatosis. 3. Clinically significant serious disease or organ system disease not currently controlled on present therapy. 4. Uncontrolled angina pectoris. 5. Pregnancy or breast feeding. 6. Previous chemotherapy. 7. Radiotherapy within the last 4 weeks prior to start of study treatment. 8. Concurrent malignancies or invasive cancers diagnosed within past 5 years except for adequately treated Basal Cell Carcinoma of the skin or in situ carcinoma of the uterine cervix 9. Known malabsorption syndromes. 10. Patients with a known hypersensitivity to any of the investigational products or patients with a dihydropyrimidine dehydrogenase (DPD) deficiency. 11. Medication which might affect immunocompetence e.g. chronic treatment with long term steroids or other immunosuppressant for an unrelated condition. Patients will be eligible if they have been receiving short term steroids for palliation of cancer related symptoms. 12. Chemotherapy directed at tumour apart from that described in this protocol. 13. All men or women of reproductive potential, unless using at least two contraceptive precautions, one of which must be a condom. |
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E.5 End points |
E.5.1 | Primary end point(s) |
To investigate the efficacy of GV1001 on length of survival when added concurrently or sequentially to combination gemcitabine and capecitabine in patients with locally advanced or metastatic pancreatic adenocarcinoma. |
|
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 | Yes |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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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 | 80 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
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 end of the trial will be one year after the last patient has been entered onto the study, with an intended final analysis 6 months later. Patients are followed up until death. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 7 |
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 | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |