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

Studying the metabolism of sorafenib (Nexavar®) by OATP1B blockage in adult cancer patients

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-001525-10-NL

Enrollment

Registered

2013-04-22

Start date

2013-07-30

Completion date

Unknown

Last updated

2024-12-09

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

Conditions

Cancer

Interventions

Trade Name: Nexavar Pharmaceutical Form: Tablet Trade Name: Rifampicine Pharmaceutical Form: Tablet Trade Name: Midazolam Pharmaceutical Form: Infusion

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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). •To study the influence of genetic polymorphisms in OATP1B involved in the metabolism of sorafenib, according to protocol METC 02.1002. •To assess the degree of CYP3A induction after administration of rifampicin for two days by measuring midazolam clearance. ;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	—

Measure

Time frame

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). •To study the influence of genetic polymorphisms in OATP1B involved in the metabolism of sorafenib, according to protocol METC 02.1002. •To assess the degree of CYP3A induction after administration of rifampicin for two days by measuring midazolam clearance. ;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

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Secondary

Measure	Time frame
Secondary end point(s): - Midazolam clearance test. - Side effects following interaction between study medication. - 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). - Side effects will be monitored from day 1 until day 11. - Genetic polymorphisms will be measured at baseline and analysed after completion of the trial.	—

Measure

Time frame

Secondary end point(s): - Midazolam clearance test. - Side effects following interaction between study medication. - 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). - Side effects will be monitored from day 1 until day 11. - Genetic polymorphisms will be measured at baseline and analysed after completion of the trial.

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Countries

Netherlands

Contacts

Public ContactRon Mathijssen

Erasmus MC

a.mathijssen@erasmusmc.nl

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026