E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Grade 3 anal intraepithelial neoplasia |
|
MedDRA Classification |
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 aim of this trial is to determine the safety and feasibility of photodynamic therapy, using systemic aminolaevulinic acid, to treat anal intraepithelial neoplasia of the anal canal. |
|
E.2.2 | Secondary objectives of the trial |
The trial also aims to collect information on the efficacy of photodynamic therapy in the treatment of anal intraepithelial neoplasia. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Patients with biopsy-proven grade 3 AIN of the anal canal, with or without involvement of the perianal skin, with no evidence of invasive cancer. 2. Males and non-pregnant females over the age of 18 years. Female patients who are pre-menopausal must practice a medically acceptable form of contraception. |
|
E.4 | Principal exclusion criteria |
1. Presence of invasive carcinoma of the anus. 2. History of severe cardiovascular disease, severe angina, congestive heart failure, or recent syncope of cardiovascular origin. 3. Patients presenting with abnormal cardiac signs or symtoms and signs of congestive heart failure on physical examination. 4. Patients with orthostatic hypotension resistant to hydration. 5. Patients who have a history of porphyria, or hypersensitivity to porphyrins. 6. Patients taking depot preparations of psychotropic medication. 7. Patients with a white cell count < 2x10e9/L. 8. Patients with a CD4 count < 200 cells/cubic mm. 9. Patients with a platelet count < 50x10e9/L. 10. Patients with a prothrombin time of > 1.5 times the upper limit of normal. 11. Patients with impaired renal and/or hepatic function at the time of entry into the study. 12. Patients receiving concurrent chemotherapy, or radiation therapy or chemotherapy within 4 weeks of entry into the study. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
The frequency of any adverse events or reactions that have occured.
|
|
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 | Yes |
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) | Yes |
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 | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
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
|
The trial will be considered to have ended 12 months after the last patient in the study has been given photodynamic therapy. NB. Patients will have regular follow-up for 12 months after the treatment with photodynamic therapy as part of the study. However, patients may continue to be followed-up after the end of the study as part of routine clinical practice. |
|
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 | 0 |
E.8.9.1 | In the Member State concerned days | 0 |