This study is open for adults with advanced cancer (solid tumours). This is a study for people for whom previous treatment was not successful. This study tests a medicine called BI 907828. BI 907828 is a so-called MDM2 inhibitor that is being developed to treat cancer. The purpose of this study is to find out whether the amount of BI 907828 in the blood is influenced by taking an OATP inhibitor or a CYP3 inhibitor. This study uses an OATP inhibitor called rifampicin and a CYP3 inhibitor called itraconazole. In clinical practice, rifampicin is used as an antibiotic. Itraconazole is used to treat fungal infections. Participants are divided into 2 groups: a rifampicin group and an itraconazole group. Every participant takes BI 907828 as a tablet every 3 weeks. This is called a cycle. * Rifampicin group: In addition to BI 907828, participants take 1 tablet of rifampicin in the second cycle. * Itraconazole group: In addition to BI 907828, participants take itraconazole tablets for 20 days starting 1 week after the second cycle begins Participants can stay in the study as long as they benefit from treatment and can tolerate it. The doctors take blood samples from the participants to compare the amount of BI 907828 in the blood when it is taken alone and when participants also take rifampicin. Doctors also regularly check participants' health and take note of any unwanted effects.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
33
Cliniques Universitaires Saint-Luc
Brussels, Belgium
Wilrijk - HOSP GZA (St-Augustinus)
Wilrijk, Belgium
Hospital Quiron. I.C.U.
Barcelona, Spain
Hospital Universitari Vall D Hebron
Barcelona, Spain
Fundación Jiménez Díaz
Madrid, Spain
CIO Clara Campal
Madrid, Spain
Hospital Quirónsalud Madrid
Madrid, Spain
Group 1: Area under the concentration-time curve of BI 907828 in plasma over the time interval from 0 to 24 hours (AUC 0-24)
Time frame: up to 24 hours
Group 1: Maximum measured concentrations of BI 907828 in plasma (C max)
Time frame: up to 15 days
Group 2: Area under the concentration-time curve of BI 907828 in plasma over the time interval from 0 to the last quantifiable data point (AUC 0-tz)
Time frame: up to 15 days
Group 2: Maximum measured concentrations of BI 907828 in plasma (C max)
Time frame: up to 15 days
Group 1: Area under the concentration-time curve of BI 907828 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
Time frame: up to 15 days
Group 1: Area under the concentration-time curve of BI 907828 in plasma over the time interval from 0 to the last quantifiable data point (AUC 0-tz)
Time frame: up to 15 days
Group 2: Area under the concentration-time curve of BI 907828 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
Time frame: up to 15 days
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