Clinical trial to study the relation in clearance between a low dose docetacel and a therpeutic dose of docetacel
Phase 1
- Conditions
- Patients with breast-, prostate or non-small cell lung cancer (NSCLC), who are eligible for treatment with docetaxel.Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2016-003785-77-NL
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
Patients with breast-, prostate and non-small cell lung cancer, who are planned for routine treatment with docetaxel
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20
Exclusion Criteria
Absence of informed consent
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of this study is to establish the relationship between microdose and therapeutic dose docetaxel pharmacokinetics;Secondary Objective: Our secondary objective is to develop a limited sampling model of microdose docetaxel pharmacokinetics to predict therapeutic dose docetaxel pharmacokinetics.;Primary end point(s): Pharmacokinetics of a microdoce- and a therapeutic dose docetaxel;Timepoint(s) of evaluation of this end point: After collection of all bloodsamples
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Pharmacokinetics of a microdoce- and a therapeutic dose docetaxel;Timepoint(s) of evaluation of this end point: After collection of all bloodsamples