Clinical trial to study the relation in clearance between a low dose docetacel and a therpeutic dose of docetacel

Microdosing as a tool to individualize docetaxel dosing: development of a limited sampling model - The MicroDoce study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-003785-77-NL

Enrollment

Registered

2016-10-13

Start date

2017-03-16

Completion date

Unknown

Last updated

2020-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with breast-, prostate or non-small cell lung cancer (NSCLC), who are eligible for treatment with docetaxel.

Interventions

Trade Name: Docetaxel Product Name: Docetaxel Pharmaceutical Form: Solution for infusion

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: Absence of informed consent

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

Measure	Time frame
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	—

Countries

Netherlands

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 7, 2026