E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
borderline resectable or unresectable pancreatic carcinoma |
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E.1.1.1 | Medical condition in easily understood language |
Advanced Pancreatic Cancer |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10033611 |
E.1.2 | Term | Pancreatic carcinoma non-resectable |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10033600 |
E.1.2 | Term | Pancreatic adenocarcinoma non-resectable |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10033606 |
E.1.2 | Term | Pancreatic cancer non-resectable |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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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 |
To assess if the addition of nelfinavir to gemcitabine and cisplatin chemoradiotherapy improves survival and merits further study. |
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E.2.2 | Secondary objectives of the trial |
To further assess the efficacy of nelfinavir + CRT Identify if there is a correlation of response in 18FDG-PET-CT imaging with response in CT imaging Identify if there is a correlation of response in imaging and survival Identify if there is a correlation of response in imaging and response in histopathology in resected patients Tolerance of nelfinavir given with chemoradiotherapy (acute and late toxicity)
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Histologically or cytologically proven, pancreatic adenocarcinoma or ampullary adenocarcinoma or intrapancreatic bile duct adenocarcinoma 2. Patients with locally advanced disease deemed suitable for CRT by the local Multidisciplinary team (MDT) OR patients with resectable cancer of the pancreas who are inoperable due to comorbidity. 3. Age >18 years 4. Karnofsky Performance Index ≥ 70 % 5. At least one measurable tumour lesion (according to RECIST) 6. Adequate bone marrow reserve (WBC ≥ 3.0 x 109/l; platelets ≥ 100 x 109/l) 7. Written informed consent 8. Patient able and willing to comply with all protocol requirements. 9. Estimated life expectancy ≥ 12 weeks |
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E.4 | Principal exclusion criteria |
1. Primary resectable cancer of the pancreas 2. Distant metastases other than para-aortic lymphadenopathy 3. History of other active invasive malignancy within the past 2 years (excluding non-melanoma skin cancer and in situ carcinoma of the cervix). 4. Previous abdominal radiotherapy. 5. Renal insufficiency (creatinine clearance <60 mL/min). 6. Liver impairment (Bilirubin ≤ 3 x upper limit of normal, ALT or AST and Alkaline Phosphatase ≤2.5 x upper limit of normal). If patients with recent biliary stent insertion are initially ineligible due to abnormal LFTs, repeated assessments may be indicated to allow inclusion of these patients as their LFTs are likely to improve with time. 7. Known haemophilia A and B, chronic hepatitis type B or C. 8. Pregnancy or breast feeding patients. Inadequate or unreliable contraceptive measures during participation in the trial. Contraceptives that contain norethisterone and ethinylestradiol must be replaced by other contraceptive methods. 9. Other experimental treatment ≤ six weeks prior to registration into this study (including chemothera¬py and immunotherapy). 10. Concurrent use of contraindicated drugs that cannot be substituted or discontinued during study treatment. 11. Known hypersensitivity to nelfinavir or any of its excipients. 12. Major systemic or psychiatric co-morbidities or any other considerations that the Principal Investigator judges might impact on patient safety or protocol compliance and achievement of the study aims. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Proportion of patients surviving to 1 year after entry into trial
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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 | No |
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 | No |
E.8.1.2 | Open | No |
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) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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 | 2 |
E.8.5 | The trial involves multiple Member States | No |
E.8.5.1 | Number of sites anticipated in the EEA | 1 |
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 | No |
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
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The ‘end of trial’ is defined as the last visit of the last patient 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 | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
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 |