Studying the influence of rifampicin administration on the processing of sorafenib in adult patients with cancer

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

• Registration Number: EUCTR2013-001525-10-NL
• Lead Sponsor: Erasmus MC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04-22
• Last Update Posted: 5 August 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- Adults with cancer, in which sorafenib treatment is indicated.
- Adequate organ function.
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 9
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 9

Exclusion Criteria

- Use of other CYP3A4 substrates.
- Prior liver transplant.
- Patients unable to undergo study procedures.

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 OATP1B inhibition, through rifampicin exposure, on the metabolism and plasma pharmacokinetics of sorafenib and its metabolites.;Secondary Objective: •To compare the incidence and severity of side effects of treatment with sorafenib in the absence and presence of rifampicin (interim-analysis after 4 patients).<br>•To study the influence of genetic polymorphisms in OATP1B involved in the metabolism of sorafenib, according to protocol METC 02.1002.<br>•To assess the degree of CYP3A induction after administration of rifampicin for two days by measuring midazolam clearance.<br>;Primary end point(s): Plasma levels of sorafenib with and without preceding rifampicin administration. ;Timepoint(s) of evaluation of this end point: On day 1 and 11 pharmacokinetic analysis will be performed, with preceding rifampicin administration on either of these days depending on randomisation

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Midazolam clearance test.<br>- Side effects following interaction between study medication.<br>- Analysis of the influence of genetic polymorphisms at baseline on sorafenib plasma levels.;Timepoint(s) of evaluation of this end point: - The midazolam clearance test will be performed on both days of pharmacokinetic analysis (day 1 and 11).<br>- Side effects will be monitored from day 1 until day 11.<br>- Genetic polymorphisms will be measured at baseline and analysed after completion of the trial.