E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with breast-, prostate or non-small cell lung cancer (NSCLC), who are eligible for treatment with docetaxel. |
Patiënten met mama-, prostaat of kleincellig longcarcinoom, die in aanmerking komen voor behandeling met docetaxel |
|
E.1.1.1 | Medical condition in easily understood language |
Patients with breast-, prostate- or lung cancer , who are eligible for treatment with docetaxel. |
Patiënten met borst-, prostaat- of longkanker die in aanmerking komen voor behandeling met docetaxel. |
|
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 |
The primary objective of this study is to establish the relationship between microdose and therapeutic dose docetaxel pharmacokinetics |
Het doel van deze studie is om te onderzoeken of er een relatie bestaat in de farmacokinetiek tussen een microdosis docetaxel en een therapeutische dosis docetaxel. |
|
E.2.2 | Secondary objectives of the trial |
Our secondary objective is to develop a limited sampling model of microdose docetaxel pharmacokinetics to predict therapeutic dose docetaxel pharmacokinetics. |
Het tweede doel van de studie is om een limited sampling model te ontwikkelen om de farmacokinetiek van een therapeutische dosis te voorspellen vanuit de farmacokinetiek van een microdosis docetaxel |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients with breast-, prostate and non-small cell lung cancer, who are planned for routine treatment with docetaxel |
Patiënten met borst-, prostaat en kleincellig longkanker, die in aanmerking komen voor behandeling met docetaxel |
|
E.4 | Principal exclusion criteria |
Absence of informed consent |
Afwezigheid van informed consent |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Pharmacokinetics of a microdoce- and a therapeutic dose docetaxel |
Farmacokinetiek van een microdosis- en therapeutische dosis docetaxel |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
After collection of all bloodsamples |
Na het verzamelen van alle bloed samples |
|
E.5.2 | Secondary end point(s) |
Pharmacokinetics of a microdoce- and a therapeutic dose docetaxel |
Farmacokinetiek van een microdosis- en therapeutische dosis docetaxel |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
After collection of all bloodsamples |
Na het verzamelen van alle bloed samples |
|
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 | No |
E.6.6 | Pharmacokinetic | Yes |
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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
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 | 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
|
Trial ends when 30 patiënts are included and had their microdoce docetaxel and first cycle of chemotherapy with docetaxel |
Trial wordt beëindigd na het includeren van 30 patiënten. En wanneer zij allen een microdose docetaxel en eerste chemokuur (therapeutische dosering) docetaxel hebben gehad. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |