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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-006682-38 | EudraCT Number |
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This study is open to adults with advanced cancer (solid tumours). People for whom previous treatment was not successful or no treatment exists can take part. This study tests a medicine called BI 907828. BI 907828 is a so-called p53-MDM2 antagonist that is being developed to treat cancer.
The purpose of the study is to find out how BI 907828 is processed in the body. In the first 3 weeks, participants therefore get a single dose of BI 907828 in a labelled form. The first participants take BI 907828 as a liquid. This is to find out how much BI 907828 is taken up in the body when it is taken by mouth. Participants who join the study later get BI 907828 as an infusion into a vein in a labelled form and take BI 907828 as a normal tablet. This is to find out how long BI 907828 stays in the blood. After the first 3 weeks, all participants take BI 907828 as tablets every 3 weeks as long as they benefit from treatment and can tolerate it.
During the study, participants visit the study site regularly. Some of the study visits include staying overnight. At the beginning, some of the participants stay at the study site for 15 nights. The doctors also regularly check participants' health and take note of any unwanted effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: Formulation 1 (Cycle 1) then BI 907828 (Cycle 2 onwards) | Experimental |
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| Cohort 2: BI 907828 (T) then Formulation 2 (R) (Cycle 1) then BI 907828 (Cycle 2 onwards) | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [¹⁴C]-BI 907828 mixed with BI 907828 (formulation 1) | Drug | [¹⁴C]-BI 907828 mixed with BI 907828 (formulation 1) |
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| Measure | Description | Time Frame |
|---|---|---|
| Cohort 1: fraction of [¹⁴C]-radioactivity excreted in urine as percentage of the administered dose over the time interval from 0 to the last quantifiable time point per patient (feurine, 0-tz) | up to 36 days | |
| Cohort 1: fraction of [14C]-radioactivity excreted in faeces as percentage of the administered dose over the time interval from 0 to the last quantifiable time point per participant (fefaeces, 0-tz) | up to 36 days | |
| Cohort 2: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to infinity (AUCo-∞) for [¹⁴C]-BI 907828 | up to 15 days | |
| Cohort 2: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to infinity (AUCo-∞) for BI 907828 | up to 15 days |
| Measure | Description | Time Frame |
|---|---|---|
| Cohort 1: : Maximum measured concentration-time curve of the analyte ([14C]-radioactivity, BI 907828 and its metabolite) in plasma (Cmax) | up to 36 days | |
| Cohort 1: Area under the concentration-time curve of the analyte over the time interval from 0 to the last quantifiable time point (AUC0-tz) |
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Inclusion Criteria:
Signed and dated written informed consent in accordance with International Conference on Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial.
Male patients, age 18-70 years; or women of non-childbearing potential* aged ≥ 18 years and ≤ 70 years at the time of signature of the ICF.
*Non-childbearing potential is defined as permanently sterile or post-menopausal. Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. Tubal ligation is NOT a method of permanent sterilization. Postmenopausal defined as at least 1 year of spontaneous amenorrhea (in questionable cases a blood sample with levels of FSH above 40 U/L or 40 IU/L and estradiol below 30 ng/L or 110.13 pmol/L is confirmatory) without an alternative medical cause.
Histologically or cytologically confirmed diagnosis of an advanced, unresectable and/or metastatic solid tumor.
Patients with measurable or non-measurable disease. Non-evaluable disease is allowed.
Patient who has failed or rejected conventional treatment or for whom no therapy of proven efficacy exists or who is not eligible for established treatment options. Patient should have exhausted available treatment options known to prolong survival for their disease.
BMI of 18.5 to 29.9 kilogram per square meter (kg/m2) at Screening.
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
All toxicities related to previous anti-cancer therapies have resolved ≤ CTCAE Grade 1 prior to trial treatment administration (except for alopecia and peripheral neuropathy which must be ≤ Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 and). Note: Patients with chronic grade 2 toxicities that are asymptomatic or adequately managed with stable medication may be eligible with approval from the Sponsor.
Further inclusion criteria apply.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PRA Hungary Ltd. | Budapest | 1077 | Hungary |
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| Label | URL |
|---|---|
| Related Info | View source |
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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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| ID | Term |
|---|---|
| C000712508 | brigimadlin |
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| [¹⁴C]-BI 907828 mixed with BI 907828 (formulation 2) | Drug | [¹⁴C]-BI 907828 mixed with BI 907828 (formulation 2) |
|
| BI 907828 | Drug | BI 907828 |
|
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| up to 36 days |
| Cohort 2: Maximum measured concentration-time curve of the analyte in plasma (Cmax) | up to 15 days |