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

• ClinicalTrials.gov Identifier: NCT05372367
• Recruitment Status: Recruiting
• First Posted: May 12, 2022
• Last Update Posted: May 9, 2024
• Sponsor: Boehringer Ingelheim
• Information provided by (Responsible Party): Boehringer Ingelheim

Tracking Information

• First Submitted Date: May 9, 2022
• First Posted Date: May 12, 2022
• Last Update Posted Date: May 9, 2024
• Actual Study Start Date: June 30, 2022
• Estimated Primary Completion Date: August 31, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 27, 2023)

• 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 ]

Original Primary Outcome Measures (submitted: May 9, 2022)

• 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 ]
• Maximum measured concentrations of BI 907828 in plasma (C max) [ Time Frame: up to 15 days ]

Current Secondary Outcome Measures (submitted: May 27, 2023)

• 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 ]

Original Secondary Outcome Measures (submitted: May 9, 2022)

• 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 ]
• 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 ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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

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: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Solid Tumors

Intervention

• Drug: BI 907828
  BI 907828
  Other Name: Brigimadlin
• Drug: Rifampicin
  Rifampicin
• Drug: Itraconazole
  Itraconazole

Study Arms

• Experimental: Group 1: OATP1B1/B3 inhibitor
  Interventions:

  • Drug: BI 907828
  • Drug: Rifampicin
• Experimental: Group 2: CYP3A4 inhibitor
  Interventions:

  • Drug: BI 907828
  • Drug: Itraconazole

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: August 30, 2023): 32
• Original Estimated Enrollment (submitted: May 9, 2022): 16
• Estimated Study Completion Date: June 30, 2025
• Estimated Primary Completion Date: August 31, 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Boehringer Ingelheim; 1-800-243-0127; clintriage.rdg@boehringer-ingelheim.com

• Listed Location Countries: Belgium, Spain

Administrative Information

• NCT Number: NCT05372367
• Other Study ID Numbers: 1403-0004; 2021-006565-38 ( EudraCT Number )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

Plan Description

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).

For more details refer to: https://www.mystudywindow.com/msw/datatransparency

• Current Responsible Party: Boehringer Ingelheim
• Original Responsible Party: Same as current
• Current Study Sponsor: Boehringer Ingelheim
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Boehringer Ingelheim
• Verification Date: May 2024