Clinical trial NCT06619509: A Study to Test Long-term Treatment With Brigimadlin in People With Solid Tumours Who Took Part in a Previous Study With This Medicine
Official title: A Phase II, Single-arm, Open-label, Long-term Safety Rollover Trial of Oral Brigimadlin in Patients With Solid Tumours
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Solid Tumours
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2024-10-01
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

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.

Primary outcomes:
measure: The primary endpoint will be the occurrence of treatment-emergent adverse events (AEs) according to CTCAE Version 5.0 during the entire treatment period
timeFrame: up to 9 years.
Secondary outcomes:
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Precision NextGen Oncology
state: California
city: Santa Monica
country: United States
facility: Sarcoma Oncology Center
state: California
city: New Haven
country: United States
facility: Yale Cancer Center
state: Connecticut
city: Jacksonville
country: United States
facility: Mayo Clinic Cancer Center
state: Florida
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Omaha
country: United States
facility: Nebraska Cancer Specialists-Omaha-69066
state: Nebraska
city: Lake Success
country: United States
facility: Northwell Health
state: New York
city: Germantown
country: United States
facility: West Cancer Center & Research Institute
state: Tennessee
city: Nashville
country: United States
facility: Henry-Joyce Cancer Clinic
state: Tennessee
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center
state: Texas
city: Salt Lake City
country: United States
facility: Utah Cancer Specialists Cancer Center
state: Utah
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center
state: Washington
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
city: Caba
country: Argentina
facility: Sanatorio Finochietto
city: Randwick
country: Australia
facility: Prince of Wales Hospital-Randwick-66496
state: New South Wales
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Bruxelles
country: Belgium
facility: Brussels - UNIV Saint-Luc
city: Leuven
country: Belgium
facility: UZ Leuven
city: Sao Paulo
country: Brazil
facility: H.S.J. Beneficência Portuguesa - São Paulo
city: Calgary
country: Canada
facility: Arthur J. E. Child Comprehensive Cancer Centre
state: Alberta
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
city: Guangzhou
country: China
facility: Sun Yat-Sen University Cancer Center
city: Olomouc
country: Czechia
facility: University Hospital Olomouc
city: København Ø
country: Denmark
facility: Copenhagen University Hospital, Rigshospitalet
city: Lyon
country: France
facility: CTR Leon Berard
city: Rennes
country: France
facility: CTR Eugène Marquis
city: Berlin
country: Germany
facility: Helios Klinikum Berlin-Buch
city: Frankfurt
country: Germany
facility: Universitätsklinikum Frankfurt
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen
city: Gyongyos
country: Hungary
facility: Clinexpert Gyongyos
city: Tel-Aviv
country: Israel
facility: Sourasky Medical Center
city: Milano
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori
city: Napoli
country: Italy
facility: Istituto Nazionale IRCCS Tumori Fondazione Pascale
city: Padova
country: Italy
facility: Istituto Oncologico Veneto IRCCS
city: Fukuoka, Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Cancer Center
city: Fukuoka, Fukuoka
country: Japan
facility: Kyushu University Hospital
city: Kanagawa, Yokohama
country: Japan
facility: Kanagawa Cancer Center
city: Miyagi, Sendai
country: Japan
facility: Tohoku University Hospital
city: Okayama, Okayama
country: Japan
facility: Okayama University Hospital
city: Osaka, Osaka
country: Japan
facility: Osaka International Cancer Institute
city: Tokyo, Chuo-ku
country: Japan
facility: National Cancer Center Hospital
city: Oslo
country: Norway
facility: Oslo Universitetssykehus HF, Radiumhospitalet
city: Warsaw
country: Poland
facility: Oncology Center-Maria Sklodowska-Curie Institute
city: Aragon
country: Spain
facility: Hospital Miguel Servet
city: Madrid
country: Spain
facility: Fundación Jiménez Díaz
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario HM Sanchinarro
city: Stockholm
country: Sweden
facility: Karolinska Comprehensive Cancer Center
city: Bern
country: Switzerland
facility: University Hospital Bern/Inselspital Bern
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital
city: London
country: United Kingdom
facility: The Royal Marsden Hospital, Chelsea
Study officials:
References: