臨床研究等提出・公開システム

A Phase II, single-arm, open-label, long-term safety rollover trial of oral brigimadlin in patients with solid tumours

A study to test long-term treatment with brigimadlin in people with solid tumours who took part in a previous study with this medicine

Kanako Taguchi

Boehringer Ingelheim

2-1-1, Osaki, Shinagawa-ku, Tokyo

medchiken.jp@boehringer-ingelheim.com

Kawahara Shizuko

Boehringer Ingelheim

2-1-1, Osaki, Shinagawa-ku, Tokyo

+81-120-189-779

medchiken.jp@boehringer-ingelheim.com

Not Recruiting

Jan. 21, 2025

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

1. Patient is ongoing on brigimadlin treatment or qualifies for crossover to brigimadlin treatment in any trial sponsored by Boehringer Ingelheim (hereafter referred to as the (parent trial)).
2. 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.
3. Women of childbearing potential (WOCBP) and men able to father a child must be ready and able to use 2 medically acceptable methods of birth control per ICH M3 (R2) that result in a low failure rate of <1% per year when used consistently and correctly beginning at Screening, during trial participation, and until 6 months and 12 days after the last dose for women and 102 days after the last dose for men. A list of contraception methods meeting these criteria and instructions on the duration of use is provided in the participant information.
4. Participants must be willing and able to comply with the scheduled visits, treatment plan, lifestyle, laboratory tests, contraceptive guidelines, and other study procedures.
5. Adequate organ function.
6. All toxicities related to previous anti-cancer therapies have resolved Common Terminology Criteria for Adverse Events (CTCAE) Grade <1 prior to trial treatment administration (except for alopecia and amenorrhea/menstrual disorders which can be any grade and peripheral neuropathy which must be CTCAE Grade <2).
Cohort 1 only:

7. Patient is eligible to receive continued treatment according to the clinical trial protocol of the parent trial they are currently participating in. Patients currently experiencing a dose delay in the parent trial due to adverse events are eligible if recovery from the adverse event takes place within the allowed time window in the parent trial.
Cohort 2 only:
8. Patient is eligible to receive crossover treatment according to the clinical trial protocol of the parent trial they are currently participating in. Patients must transition directly from the parent trial to this trial, with no further anti-cancer therapies except those that are allowed by the clinical trial protocol of the parent trial.
Further inclusion criteria apply.

1. Any medical condition which in the opinion of the investigator should exclude the patient from receiving treatment with brigimadlin.
2. Participants who must receive or intend to receive restricted medications or any drug considered likely to interfere with the safe conduct of the trial.
3. Women who are pregnant, nursing, or who plan to become pregnant while in the trial. Female patients who do not agree to the interruption of breastfeeding from the start of study treatment until 6 months and 12 days after the last dose of study treatment.
Cohort 1 only:
4. Patient has disease progression or unacceptable toxicity on brigimadlin at the time of transition into this trial.
5. Patient has an adverse event (AE) which has caused a dose delay and has not recovered within the allowed time window in the parent trial.
6. 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.
Further exclusion criteria apply.

Both

solid tumours

Brigimadlin

The primary endpoint will be the occurrence of treatment emergent AEs according to Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 during the entire treatment period.

Jan. 06, 2025

Yes

Once the criteria in section 'time frame' are fulfilled, researchers can use the following link https:// www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

Australia/Belgium/Brazil/China/Denmark/Germany/Great Britain and Northern Ireland /Hungary/Israel/Poland/Spain/Sweden