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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06619509




Registration number
NCT06619509
Ethics application status
Date submitted
27/09/2024
Date registered
1/10/2024
Date last updated
15/01/2025

Titles & IDs
Public title
A Study to Test Long-term Treatment With Brigimadlin in People With Solid Tumours Who Took Part in a Previous Study With This Medicine
Scientific title
A Phase II, Single-arm, Open-label, Long-term Safety Rollover Trial of Oral Brigimadlin in Patients With Solid Tumours
Secondary ID [1] 0 0
2024-514177-21-00
Secondary ID [2] 0 0
1403-0032
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Solid Tumours 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Brigimadlin

Experimental: Brigimadlin -


Treatment: Drugs: Brigimadlin
Brigimadlin
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The primary endpoint will be the occurrence of treatment-emergent adverse events (AEs) according to CTCAE Version 5.0 during the entire treatment period
Timepoint [1] 0 0
up to 9 years.

Eligibility
Key inclusion criteria
Inclusion criteria:

All patients:

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/12/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2036
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Prince of Wales Hospital-Randwick-66496 - Randwick
Recruitment hospital [2] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [3] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment postcode(s) [2] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [3] 0 0
3000 - Melbourne
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Bruxelles
Country [2] 0 0
Belgium
State/province [2] 0 0
Leuven
Country [3] 0 0
Brazil
State/province [3] 0 0
Sao Paulo
Country [4] 0 0
China
State/province [4] 0 0
Chengdu
Country [5] 0 0
China
State/province [5] 0 0
Guangzhou
Country [6] 0 0
Denmark
State/province [6] 0 0
København Ø
Country [7] 0 0
Germany
State/province [7] 0 0
Berlin
Country [8] 0 0
Germany
State/province [8] 0 0
Tübingen
Country [9] 0 0
Hungary
State/province [9] 0 0
Gyongyos
Country [10] 0 0
Israel
State/province [10] 0 0
Tel-Aviv
Country [11] 0 0
Japan
State/province [11] 0 0
Aichi, Nagoya
Country [12] 0 0
Japan
State/province [12] 0 0
Fukuoka, Fukuoka
Country [13] 0 0
Japan
State/province [13] 0 0
Miyagi, Sendai
Country [14] 0 0
Japan
State/province [14] 0 0
Okayama, Okayama
Country [15] 0 0
Japan
State/province [15] 0 0
Osaka, Osaka
Country [16] 0 0
Japan
State/province [16] 0 0
Tokyo, Chuo-ku
Country [17] 0 0
Poland
State/province [17] 0 0
Warsaw
Country [18] 0 0
Spain
State/province [18] 0 0
Barcelona
Country [19] 0 0
Spain
State/province [19] 0 0
L'Hospitalet de Llobregat
Country [20] 0 0
Spain
State/province [20] 0 0
Madrid
Country [21] 0 0
Spain
State/province [21] 0 0
Santiago de Compostela
Country [22] 0 0
Sweden
State/province [22] 0 0
Stockholm
Country [23] 0 0
United Kingdom
State/province [23] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Boehringer Ingelheim
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/study/NCT06619509
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Boehringer Ingelheim
Address 0 0
Country 0 0
Phone 0 0
1-800-243-0127
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06619509