E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with newly diagnosed metastatic pancreatic cancer |
|
E.1.1.1 | Medical condition in easily understood language |
Patients with newly diagnosed metastatic pancreatic 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 |
We aim to test the feasibility of Methimazole at a starting dose of 5 mg/day in patients with advanced pancreatic cancer |
|
E.2.2 | Secondary objectives of the trial |
We aim to test the effects of pharmacologically induced subclinical hypothyroidism on cancer progression compared to a retrospective control group matched for sex, age, cancer entity, stage of disease and chemotherapy regimens. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• > 18 years • Histologically proven malignancy (pancreatic ductal adenocarcinoma) • Radiologically confirmed metastatic disease by RECIST criteria • Leucocyte count > 3 G/l |
|
E.4 | Principal exclusion criteria |
• Current thyreostatic therapy • Current T4 or T3 substitution therapy • TSH < 0.4 uIqU/ml or > 4 uIU/ml • AST, ALT > 3x ULN • GFR < 30 ml/min • Known allergy against methimazole • Pregnancy / breastfeeding • ECOG ≥ 2 • Participation in another interventional study |
|
E.5 End points |
E.5.1 | Primary end point(s) |
• Presence of subclinical hypothyroidism (TSH > 4 uIU/ml) after 12 weeks treatment with methimazole |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
After 12 weeks of treatment |
|
E.5.2 | Secondary end point(s) |
• quality of life (ThyPRO; EORTC QLQ-C30 Version 3; EORTC QLQ-FA12) • number of interruptions of methimazole treatment due to fatigue • number of interruptions of methimazole treatment due to leucopenia • number of interruptions of methimazole treatment due to elevated liver parameters • progression-free survival (interval from start of chemotherapy until progression of disease or death of any cause) • best clinical benefit rate (stable disease + partial response + complete response) compared to the matched control group • best objective response rate (partial response + complete response) compared to the matched control group • CRP/Albumin ratio after 12 weeks compared to the matched control group • Neutrophil-to-lymphocyte ratio after 12 weeks compared to the matched control group • Leucocyte-to-lymphocyte ratio after 12 weeks compared to the matched control group • Platelet-to-lymphocyte ratio after 12 weeks compared to the matched control group • Monocyte-to-lymphocyte ratio after 12 weeks compared to the matched control group • CA 19-9, CEA after 12 weeks compared to the matched control group |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
After 12 weeks of treatment |
|
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 | 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 | 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 | 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
|
|
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 |