A study to determine the influence of prednisone on the bioavailability and metabolisation of docetaxel.

Phase 1

Active, not recruiting

• Conditions: Metastatic prostate cancer; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2016-001269-10-NL
• Lead Sponsor: Erasmus MC Cancer Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06-20
• Last Update Posted: 7 May 2018

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: Male
• Target Recruitment: 18

Inclusion Criteria

1.Histologicallly or cytologically confirmed adenocarcinoma of the prostate without neuro-endocrine differentitation or small cell features.
2.Continued androgen deprivation therapy either by gonadotropin releasing hormone (GnRH) analogues or orchiedectomy
3.Age =18 years
4.Metastatic disease progression
5.ECOG performance status 0-1
6.Written informed consent according to ICH-GCP

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 6
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 12

Exclusion Criteria

1.Impossibility or unwillingness to take oral drugs
2.Serious concurrent illness or medical unstable condition requiring treatment
3.Symptomatic CNS metastases or history of psychiatric disorder that would prohibit the understanding and giving of informed consent
4.Known hypersensitivity to studiemedication
5.Use of medication or dietary supplements known to induce CYP3A
6.Any active systemic or local bacterial, viral, fungal - or yeast infection.
7.Abnormal renal function defined as (within 21 days before randomization)
8.Abnormal liver functions consisting of any of the following (within 21 days before randomization):
9.Abnormal hematological blood counts consisting of any of the following (within 21 days before randomization):
10.Geographical, psychological or other non-medical conditions interfering with follow-up

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine the influence of prednisone use on the pharmacokinetics (primary parameter AUC) of docetaxel, compared to docetaxel alone, in mCRPC and mHSPC patients. ;Secondary Objective: •To evaluate the incidence and severity of side-effects of treatment with docetaxel in absence and presence of prednisone. <br>•Other pharmacokinetic outcomes (i.e. clearance, maximum concentration (Cmax));Primary end point(s): To determine the influence of prednisone use on the pharmacokinetics (primary parameter AUC) of docetaxel, compared to docetaxel alone, in mCRPC and mHSPC patients. ;Timepoint(s) of evaluation of this end point: End of study

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): •To evaluate the incidence and severity of side-effects of treatment with docetaxel in absence and presence of prednisone. <br>•Other pharmacokinetic outcomes (i.e. clearance, maximum concentration (Cmax));Timepoint(s) of evaluation of this end point: End of Study