50 Participants Needed

Brigimadlin for Cancer

Recruiting at 63 trial locations
BI
Overseen ByBoehringer Ingelheim
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Boehringer Ingelheim
Must be taking: Brigimadlin
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

This study is open to adults who participated in a previous clinical study with brigimadlin. The goal of this study is to find out how well people with solid tumours tolerate long-term treatment with brigimadlin. Brigimadlin is a so-called MDM2 inhibitor that is being developed to treat cancer. Participants are grouped in cohorts depending on their treatment in the previous study: * Cohort 1a got brigimadlin and continues treatment with brigimadlin * Cohort 1b got brigimadlin for 4 or less treatment cycles; each cycle was 3 weeks long * Cohort 2 received a comparator and gets brigimadlin for the first time All participants take brigimadlin as tablets once every 3 weeks at the study site. Participants in the Cohorts 1b and 2 visit the sites more frequently. At study visits, doctors check participants' health and take note of any unwanted effects. At some study visits, doctors also check the size of the tumour and whether it has spread to other parts of the body. Participants are in the study as long as they benefit from treatment and can tolerate it.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it mentions that participants should not receive restricted medications or any drug that might interfere with the trial. It's best to discuss your current medications with the trial team to see if they are allowed.

Eligibility Criteria

Adults with solid tumors who were in a previous brigimadlin study can join. They must be able to continue treatment, have signed consent, use effective birth control, and follow the trial's procedures. Their organs must work well and any past treatment side effects should be mild.

Inclusion Criteria

I am currently on brigimadlin or eligible to switch to it in a Boehringer Ingelheim trial.
My side effects from previous cancer treatments are mild, except for hair loss, menstrual changes, or slight nerve pain.
Provision of signed and dated, written informed consent form (ICF) in accordance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use - Good Clinical Practice (ICH-GCP) and local legislation prior to any trial-specific procedures, sampling, or analyses
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Exclusion Criteria

I am not pregnant, nursing, nor planning to become pregnant during the trial, and agree to stop breastfeeding.
My condition worsened or I had severe side effects on brigimadlin.
Patient who has already required 2 dose reductions and would require a third dose reduction at trial entry, unless the investigator deems treatment continuation beneficial, and the third dose reduction is agreed between the investigator and the sponsor
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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants take brigimadlin as tablets once every 3 weeks at the study site. Health checks and monitoring for adverse effects are conducted.

As long as participants benefit and can tolerate the treatment
Every 3 weeks (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension

Participants continue long-term treatment with brigimadlin as long as they benefit and can tolerate it

Up to 9 years

Treatment Details

Interventions

  • Brigimadlin
Trial Overview The trial tests long-term tolerance of brigimadlin in cancer patients from prior studies. It involves different cohorts based on previous exposure to brigimadlin or a comparator drug, with all now taking brigimadlin tablets every three weeks.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: BrigimadlinExperimental Treatment1 Intervention

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Who Is Running the Clinical Trial?

Boehringer Ingelheim

Lead Sponsor

Trials
2,566
Recruited
16,150,000+
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