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NCT05372367 | Recruiting | Solid Tumors

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
Sponsor:

Boehringer Ingelheim

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.

Condition or disease

Solid Tumors

Intervention/treatment

BI 907828

Rifampicin

Itraconazole

Phase

Phase 1

Study Type : Interventional
Estimated Enrollment : 32 participants
Masking : None (Open Label)
Primary Purpose : Treatment
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
Actual Study Start Date : June 30, 2022
Estimated Primary Completion Date : August 31, 2024
Estimated Study Completion Date : June 30, 2025
Arm Intervention/treatment

Experimental: Group 1: OATP1B1/B3 inhibitor

Comrade: BI 907828

Drug: Rifampicin

Experimental: Group 2: CYP3A4 inhibitor

Comrade: BI 907828

Drug: Itraconazole
Ages Eligible for Study: 18 Years to 70 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion criteria
  • Age ≥18 and ≤70 years.
  • Signed and dated written informed consent in accordance with International Council on Harmonisation - Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial.
  • Male or female patients. Women of childbearing potential (WOCBP) and men able to father a child must be ready and able to use two medically acceptable methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly beginning at screening, during trial participation, and until 6 months and 12 days after last dose for women and 102 days after last dose for men. A list of contraception methods meeting these criteria is provided in the patient information.
  • Patients with histologically or cytologically confirmed diagnosis of advanced, non resectable and/or metastatic solid tumour.
  • Patient with either measurable or non-measurable disease. Non-evaluable disease is allowed.
  • Patient who has failed conventional treatment or for whom no therapy of proven efficacy exists or who is not eligible for established treatment options. Patient must have exhausted available treatment options known to prolong survival for their disease.
  • Patient has a tumour with either a known Tumor Protein p53 (TP53) wild type status, or unknown TP53 status, at the time of study entry.
  • Eastern Cooperative Oncology Group (ECOG) performance score 0 or 1. Further inclusion criteria apply.
  • Exclusion criteria
    • Second malignancy currently requiring active therapy (except for hormonal /antihormonal treatment e.g. in prostate or breast cancer).
    • Chemo-, radio- immuno-, or molecular-targeted cancer-therapy within the past four weeks prior to start of BI 907828. This restriction does not apply to steroids, bisphosphonates hormonal / antihormonal treatment (e.g. in prostate or breast cancer).
    • Serious concomitant disease or medical condition which may affect compliance with trial requirements in the opinion of the Investigator.
    • Clinical evidence of active brain metastasis or leptomeningeal disease in the past 6 months prior to screening.
    • Active major infection requiring systemic treatment (antibacterial, antiviral, or antifungal therapy) at treatment start in this trial.
    • Known history of human immunodeficiency virus infection.
    • Patients with a history of Hepatitis C virus (HCV) infection who meet one or both of the following criteria
      • Currently receiving curative antiviral treatment
      • HCV viral load is above the limit of quantification (HCV RNA positive)
      • Patients with chronic Hepatitis B virus (HBV) infection with active disease who meet the criteria for anti-HBV therapy (according to local / institutional standard) and who have not been treated with suppressive antiviral therapy prior to initiation of study treatment.
      • Further exclusion criteria apply.
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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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

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Recruiting

Belgium,

Brussels - UNIV Saint-Luc

Bruxelles, Belgium, 1200

Recruiting

Belgium,

Wilrijk - HOSP GZA (St-Augustinus)

Wilrijk, Belgium, 2610

Recruiting

Spain,

Chiron Hospital. I.C.U.

Barcelona, Spain, 08023

Recruiting

Spain,

Hebron Valley Hospital

Barcelona, Spain, 08035

Recruiting

Spain,

Jiménez Díaz Foundation

Madrid, Spain, 28040

Recruiting

Spain,

CIO Clara Campal

Madrid, Spain, 28050

Recruiting

Spain,

Quirónsalud Hospital Madrid

Madrid, Spain, 28223