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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

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ClinicalTrials.gov Identifier: NCT05372367
Recruitment Status : Recruiting
First Posted : May 12, 2022
Last Update Posted : August 31, 2023
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Description
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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 Intervention/treatment Phase
Solid Tumors Drug: BI 907828 Drug: Rifampicin Drug: Itraconazole Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: N/A
Intervention Model: Single Group Assignment
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
Arms and Interventions
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Arm Intervention/treatment
Experimental: Group 1: OATP1B1/B3 inhibitor Drug: BI 907828
BI 907828
Other Name: Brigimadlin

Drug: Rifampicin
Rifampicin
Experimental: Group 2: CYP3A4 inhibitor Drug: BI 907828
BI 907828
Other Name: Brigimadlin

Drug: Itraconazole
Itraconazole


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
  2. Group 1: Maximum measured concentrations of BI 907828 in plasma (C max) [ Time Frame: up to 15 days ]
  3. 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 ]
  4. Group 2: Maximum measured concentrations of BI 907828 in plasma (C max) [ Time Frame: up to 15 days ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05372367


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

Locations
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Belgium
Brussels - UNIV Saint-Luc Recruiting
Bruxelles, Belgium, 1200
Contact: Boehringer Ingelheim    080049616    belgique@bitrialsupport.com   
Wilrijk - HOSP GZA (St-Augustinus) Recruiting
Wilrijk, Belgium, 2610
Contact: Boehringer Ingelheim    080049616    belgique@bitrialsupport.com   
Spain
Hospital Quiron. I.C.U. Recruiting
Barcelona, Spain, 08023
Contact: Boehringer Ingelheim    900876092    espana@bitrialsupport.com   
Hospital Vall d'Hebron Recruiting
Barcelona, Spain, 08035
Contact: Boehringer Ingelheim    900876092    espana@bitrialsupport.com   
Fundación Jiménez Díaz Recruiting
Madrid, Spain, 28040
Contact: Boehringer Ingelheim    900876092    espana@bitrialsupport.com   
CIO Clara Campal Recruiting
Madrid, Spain, 28050
Contact: Boehringer Ingelheim    900876092    espana@bitrialsupport.com   
Hospital Quirónsalud Madrid Recruiting
Madrid, Spain, 28223
Contact: Boehringer Ingelheim    900876092    espana@bitrialsupport.com   
Sponsors and Collaborators
Boehringer Ingelheim
More Information
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Additional Information:

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT05372367    
Other Study ID Numbers: 1403-0004
2021-006565-38 ( EudraCT Number )
First Posted: May 12, 2022    Key Record Dates
Last Update Posted: August 31, 2023
Last Verified: August 2023
Individual Participant Data (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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Itraconazole
Rifampin
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
 Cytochrome P-450 CYP3A Inhibitors
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Leprostatic Agents
Nucleic Acid Synthesis Inhibitors
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP2C8 Inducers
Cytochrome P-450 CYP2C19 Inducers
Cytochrome P-450 CYP2C9 Inducers
Cytochrome P-450 CYP3A Inducers