E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
pancreatic exocrine insufficiency (PEI) in patients with unresectable pancreatic cancer. |
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E.1.1.1 | Medical condition in easily understood language |
controlled trial of pancreatic enzyme replacement therapy (PERT) for pancreatic exocrine insufficiency (PEI) in patients with unresectable pancreatic cancer. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Digestive System Diseases [C06] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
the primary objective of the study is to evaluate the impact of PERT on body weight in patients with PEI secondary to unresectable pancreatic cancer. |
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E.2.2 | Secondary objectives of the trial |
Secondary aim is to evaluate the impact of PERT on: - Nutritional status - Karnofsky performance status. - Abdominal symptoms. - Quality of life. - Tolerance to chemotherapy. - Survival. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients older than 18 years, any gender, fulfilling the following criteria will be considered for the study: 1. Unresectable, locally advanced or metastatic, pancreatic cancer. 2. Tumour located in the head of the pancreas. 3. Dilated main pancreatic duct confirmed by imaging methods (CT scan, MRI and/or EUS). 4. Significant weight loss (≥5% of the usual body weight). 5. Life expectancy of at least six months at screening. 6. Signed informed consent to the study. |
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E.4 | Principal exclusion criteria |
1. Patients with indication of neoadjuvant chemotherapy. 2. History of pancreatic or gastric surgery. 3. Short life expectancy (shorter than 6 months). 4. Patients on second line or beyond chemotherapy (those who failed with first line chemotherapy) at inclusion. 5. Patients in whom a pancreatic stent has been placed. 6. Unsolved gastric outlet obstruction. 7. Known allergy to porcine proteins. 8. Unwillingness to participate in the study. 9. Inability to comply with the study visits and study protocol, whatever the reason. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint is defined as the change in body weight (kg and percentage) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Over 3 and 6 months from inclusion. |
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E.5.2 | Secondary end point(s) |
- Change in haemoglobin, lymphocytes, serum concentration of nutritional markers (albumin, prealbumin, retinol binding protein, transferrin, fat-soluble vitamins, total and HDL cholesterol, triglycerides, cholinesterase, magnesium, selenium, and zinc) and HbA1C. - Change in Karnofsky performance status from baseline to the end of the controlled phase and the end of the study in the two groups of patients. - Change in malabsorption-related symptoms (diarrhoea, flatulence, abdominal distention, meteorism, abdominal cramps) and Patient-Generated Subjective Global Assessment (PG-SGA). - Change in quality of life (EORTC QLQ-PAN26). - Tolerance to chemotherapy defined as the percentage of the optimal dose of chemotherapeutic agents administered. - Survival. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Over 3 and 6 months from inclusion. |
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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 | No |
E.6.13 | Others | No |
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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
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 | No |
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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 5 |
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 | No |
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 |
France |
Spain |
Sweden |
United Kingdom |
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E.8.7 | Trial has a data monitoring committee | No |
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
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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 | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |