Status:
COMPLETED
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
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Solid Tumors
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
August 11 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 9 2025
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT05372367
Start Date
August 11 2022
End Date
May 9 2025
Last Update
August 5 2025
Active Locations (7)
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1
Brussels - UNIV Saint-Luc
Brussels, Belgium, 1200
2
Wilrijk - HOSP GZA (St-Augustinus)
Wilrijk, Belgium, 2610
3
Hospital Quiron. I.C.U.
Barcelona, Spain, 08023
4
Hospital Vall d'Hebron
Barcelona, Spain, 08035