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Spots Global Cancer Trial Database for A Study in People With Advanced Cancer to Test Whether the Amount of BI 907828 in the Blood is Influenced by Taking an OATP Inhibitor or a CYP3 Inhibitor

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Trial Identification

Brief Title: A Study in People With Advanced Cancer to Test Whether the Amount of BI 907828 in the Blood is Influenced by Taking an OATP Inhibitor or a CYP3 Inhibitor

Official Title: An Open-label Fixed Sequence Trial to Investigate the Potential Drug-drug Interaction When BI 907828 is Co-administered With an OATP1B1 and/or OATP1B3 Transporter Inhibitor or With a CYP3A4 Inhibitor in Patients With Various Solid Tumours

Study ID: NCT05372367

Conditions

Solid Tumors

Study Description

Brief Summary: 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.

Detailed Description:

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Brussels - UNIV Saint-Luc, Bruxelles, , Belgium

Wilrijk - HOSP GZA (St-Augustinus), Wilrijk, , Belgium

Hospital Quiron. I.C.U., Barcelona, , Spain

Hospital Vall d'Hebron, Barcelona, , Spain

Fundación Jiménez Díaz, Madrid, , Spain

CIO Clara Campal, Madrid, , Spain

Hospital Quirónsalud Madrid, Madrid, , Spain

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

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