E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with confirmed primary endometrioid adenocarcinoma eligible for first line curative surgery |
|
E.1.1.1 | Medical condition in easily understood language |
Patients with uterine cancer |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
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 |
To determine whether neoadjuvant treatment with celecoxib results in reduced tumoural expression of IDO1 and/or increased tumoural T-cell infiltration in patients with endometrial carcinoma |
|
E.2.2 | Secondary objectives of the trial |
To assess the safety and tolerability of treatment with celecoxib |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Women > 18 years of age.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
- Adequate renal, hepatic and haematologic functions as defined by laboratory parameters.
- Agrees to undergo additional endometrial biopsies for scientific purposes. |
|
E.4 | Principal exclusion criteria |
- Known hypersensitivity or intolerance to celecoxib
- Active, known or suspected autoimmune disease. Vitiligo, type I diabetes mellitus, residual hypothyroidism controlled by hormone substitution therapy, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are allowed.
- Positive hepatitis B or C, HIV, and pregnancy tests.
- Immunosuppressive treatment |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Decrease in the proportion of IDO1+ tumour cells by ≥50%, and increase in the proportion of CD3+ T-cells infiltrating the tumor bed by ≥50% following celecoxib treatment, as measured by immunostaining and computerized analysis of digitized histological images |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
the day of the surgery, from 12 to 24 hours after last intake of medication |
|
E.5.2 | Secondary end point(s) |
Assessment and scaling of adverse events according to CTC-NCIv4.03, and of surgical safety according to the Dindo-Clavien scale for evaluation of post-operative complications |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
from the first intake of medication to 24 hours afeter surgey |
|
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 | No |
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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
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.8.6 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
|
end of trail = 24 hours after the last patient's surgery |
|
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 | 1 |
E.8.9.1 | In the Member State concerned days | 0 |