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

Solid Tumors Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05372367
• Other study ID #: 1403-0004
• Secondary ID: 2021-006565-38
• Status: Recruiting
• Phase: Phase 1
• Start date: June 30, 2022
• Est. completion date: June 30, 2025

Study information

• Verified date: May 2024
• Source: Boehringer Ingelheim
• Contact: Boehringer Ingelheim
• Phone: 1-800-243-0127
• Email: clintriage.rdg[@]boehringer-ingelheim.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: June 30, 2025
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion criteria:

1. Age =18 and =70 years.

2. 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.

3. 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.

4. Patients with histologically or cytologically confirmed diagnosis of advanced, non resectable and/or metastatic solid tumour.

5. Patient with either measurable or non-measurable disease. Non-evaluable disease is allowed.

6. 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.

7. 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.

8. Eastern Cooperative Oncology Group (ECOG) performance score 0 or 1. Further inclusion criteria apply.

Exclusion criteria:

1. Second malignancy currently requiring active therapy (except for hormonal /antihormonal treatment e.g. in prostate or breast cancer).

2. 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).

3. Serious concomitant disease or medical condition which may affect compliance with trial requirements in the opinion of the Investigator.

4. Clinical evidence of active brain metastasis or leptomeningeal disease in the past 6 months prior to screening.

5. Active major infection requiring systemic treatment (antibacterial, antiviral, or antifungal therapy) at treatment start in this trial.

6. Known history of human immunodeficiency virus infection.

7. 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)

8. 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.

Related Conditions & MeSH terms

• Solid Tumors

Intervention

Drug:
• BI 907828
BI 907828
• Rifampicin
Rifampicin
• Itraconazole
Itraconazole

Locations

Country	Name	City	State
Belgium	Brussels - UNIV Saint-Luc	Bruxelles
Belgium	Wilrijk - HOSP GZA (St-Augustinus)	Wilrijk
Spain	Hospital Quiron. I.C.U.	Barcelona
Spain	Hospital Vall d'Hebron	Barcelona
Spain	CIO Clara Campal	Madrid
Spain	Fundación Jiménez Díaz	Madrid
Spain	Hospital Quirónsalud Madrid	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

Belgium,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)		up to 24 hours
Primary	Group 1: Maximum measured concentrations of BI 907828 in plasma (C max)		up to 15 days
Primary	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)		up to 15 days
Primary	Group 2: Maximum measured concentrations of BI 907828 in plasma (C max)		up to 15 days
Secondary	Group 1: Area under the concentration-time curve of BI 907828 in plasma over the time interval from 0 extrapolated to infinity (AUC0-8)		up to 15 days
Secondary	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)		up to 15 days
Secondary	Group 2: Area under the concentration-time curve of BI 907828 in plasma over the time interval from 0 extrapolated to infinity (AUC0-8)		up to 15 days

External Links

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