E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Unresectable pancreatic cancer |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10033604 |
E.1.2 | Term | Pancreatic cancer |
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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 |
The trial aims to investigate the safety and efficacy of verteporfin photodynamic therapy in patients with locally advanced pancreatic carcinoma. The primary endpoint is the diameter of necrosis of tumour achieved around a single fibre for a given light energy. The study endpoint will be achieved with a 12 mm zone of necrosis around the fibre in 3 patients at a particular light dose. |
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E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. A histopathological/cytological diagnosis of pancreatic carcinoma, which is locally advanced and not amenable to curative surgical resection, or the patient is unfit for or declines surgery. 2. ECOG performance status 0, 1 or 2 3. Estimated life expectancy of at least 12 weeks 4. Age >18 years 5. Women of child-bearing potential with a negative pregnancy test (qualitative serum hCG) prior to study entry AND be using an adequate contraception method, which must be continued for 1 week after PDT 6. Capable of giving written informed consent 7. Adequate biliary drainage (serum bilirubin < 2.5 ULN), with no evidence of active uncontrolled infection (patients on antibiotics are eligible)
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E.4 | Principal exclusion criteria |
1. Porphyria 2. Previous treatment with curative intent for current disease in the last 4 weeks (ie. Prior resection, radical radiotherapy or chemotherapy) 3. History of active or prior malignancy that will interfere with the response evaluation 4. Any evidence of severe or uncontrolled systemic diseases or laboratory finding that in the view of the investigator makes it undesirable for the patient to participate in the trial 5. Any psychiatric disorder making reliable informed consent impossible 6. Locally advanced disease involving > 50% circumference of the duodenum or a major artery (hepatic, gastroduodenal) within the treatment area. 7. Metastatic disease 8. Pregnancy or breast-feeding 9. ECOG performance status 3 or 4
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint is the diameter of necrosis of tumour achieved around a single fibre for a given light energy. The study endpoint will be achieved with a 12 mm zone of necrosis around the fibre in 3 patients at a particular light dose. |
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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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
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) | 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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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 | 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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End of trial is defined as one month from the date that the last patient has completed trial therapy. After this point patients will be in the non-interventional, follow up stage of the study, seen as outpatients on a 3 monthly basis which reflects standard practice for this patient group |
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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 | |