Phase
Condition
Neoplasms
All Solid Tumors
Treatment
Brigimadlin
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion criteria:
All patients:
Patient is ongoing on brigimadlin treatment or qualifies for crossover tobrigimadlin treatment in any trial sponsored by Boehringer Ingelheim (hereafterreferred to as the 'parent trial').
Provision of signed and dated, written informed consent form (ICF) in accordancewith International Council for Harmonisation of Technical Requirements forPharmaceuticals for Human Use - Good Clinical Practice (ICH-GCP) and locallegislation prior to any trial-specific procedures, sampling, or analyses.
Women of childbearing potential (WOCBP) and men able to father a child must be readyand able to use 2 medically acceptable methods of birth control per ICH M3 (R2) thatresult in a low failure rate of <1% per year when used consistently and correctlybeginning at Screening, during trial participation, and until 6 months and 12 daysafter the last dose for women and 102 days after the last dose for men. A list ofcontraception methods meeting these criteria and instructions on the duration of useis provided in the participant information.
Participants must be willing and able to comply with the scheduled visits, treatmentplan, lifestyle, laboratory tests, contraceptive guidelines, and other studyprocedures.
Adequate organ function.
All toxicities related to previous anti-cancer therapies have resolved CommonTerminology Criteria for Adverse Events (CTCAE) Grade ≤1 prior to trial treatmentadministration (except for alopecia and amenorrhea/menstrual disorders which can beany grade and peripheral neuropathy which must be CTCAE Grade ≤2). Cohort 1 only:
Patient is eligible to receive continued treatment according to the clinical trialprotocol of the parent trial they are currently participating in. Patients currentlyexperiencing a dose delay in the parent trial due to adverse events are eligible ifrecovery from the adverse event takes place within the allowed time window in theparent trial. Cohort 2 only:
Patient is eligible to receive crossover treatment according to the clinical trialprotocol of the parent trial they are currently participating in. Patients musttransition directly from the parent trial to this trial, with no further anti-cancertherapies except those that are allowed by the clinical trial protocol of the parenttrial.
Further inclusion criteria apply.
Exclusion
Exclusion criteria:
Any medical condition which in the opinion of the investigator should exclude thepatient from receiving treatment with brigimadlin.
Participants who must receive or intend to receive restricted medications or anydrug considered likely to interfere with the safe conduct of the trial.
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 startof study treatment until 6 months and 12 days after the last dose of studytreatment. Cohort 1 only:
Patient has disease progression or unacceptable toxicity on brigimadlin at the timeof transition into this trial.
Patient has an adverse event (AE) which has caused a dose delay and has notrecovered within the allowed time window in the parent trial.
Patient who has already required 2 dose reductions and would require a third dosereduction at trial entry, unless the investigator deems treatment continuationbeneficial, and the third dose reduction is agreed between the investigator and thesponsor.
Further exclusion criteria apply.
Study Design
Connect with a study center
Sanatorio Finochietto
Caba, C1120AAB
ArgentinaSite Not Available
Prince of Wales Hospital-Randwick-66496
Randwick, New South Wales 2031
AustraliaSite Not Available
Princess Alexandra Hospital
Woolloongabba, Queensland 4102
AustraliaSite Not Available
Peter MacCallum Cancer Centre
Melbourne, Victoria 3000
AustraliaSite Not Available
Brussels - UNIV Saint-Luc
Bruxelles, 1200
BelgiumSite Not Available
Edegem - UNIV UZ Antwerpen
Edegem, 2650
BelgiumSite Not Available
UZ Leuven
Leuven, 3000
BelgiumSite Not Available
H.S.J. Beneficência Portuguesa - São Paulo
Sao Paulo, 01323-001
BrazilSite Not Available
West China Hospital
Chengdu, 610041
ChinaSite Not Available
Sun Yat-Sen University Cancer Center
Guangzhou, 510060
ChinaSite Not Available
University Hospital Olomouc
Olomouc, 77900
CzechiaSite Not Available
Copenhagen University Hospital, Rigshospitalet
København Ø, 2100
DenmarkSite Not Available
CTR Leon Berard
Lyon, 69373
FranceSite Not Available
CTR Eugène Marquis
Rennes, 35042
FranceSite Not Available
Helios Klinikum Berlin-Buch
Berlin, 13125
GermanySite Not Available
Universitätsklinikum Frankfurt
Frankfurt, 60590
GermanySite Not Available
Universitätsklinikum Tübingen
Tübingen, 72076
GermanySite Not Available
Clinexpert Gyongyos
Gyongyos, 3200
HungarySite Not Available
Sourasky Medical Center
Tel-Aviv, 6423906
IsraelSite Not Available
Fondazione IRCCS Istituto Nazionale dei Tumori
Milano, 20133
ItalySite Not Available
Istituto Nazionale IRCCS Tumori Fondazione Pascale
Napoli, 80131
ItalySite Not Available
Istituto Oncologico Veneto IRCCS
Padova, 35128
ItalySite Not Available
Nagoya University Hospital
Aichi, Nagoya, 466-8560
JapanSite Not Available
Kyushu University Hospital
Fukuoka, Fukuoka, 812-8582
JapanSite Not Available
National Hospital Organization Kyushu Cancer Center
Fukuoka, Fukuoka, 811-1395
JapanSite Not Available
Kanagawa Cancer Center
Kanagawa, Yokohama, 241-8515
JapanSite Not Available
Tohoku University Hospital
Miyagi, Sendai, 980-8574
JapanSite Not Available
Okayama University Hospital
Okayama, Okayama, 700-8558
JapanSite Not Available
Osaka International Cancer Institute
Osaka, Osaka, 541-8567
JapanSite Not Available
National Cancer Center Hospital
Tokyo, Chuo-ku, 104-0045
JapanActive - Recruiting
Nederlands Kanker Instituut
Amsterdam, 1066 CX
NetherlandsSite Not Available
Oslo Universitetssykehus HF, Radiumhospitalet
Oslo, N-0379
NorwaySite Not Available
Oncology Center-Maria Sklodowska-Curie Institute
Warsaw, 02-781
PolandSite Not Available
Hospital Vall d'Hebron-Barcelona-47683
Barcelona, 08035
SpainSite Not Available
Hospital del Mar
Barcelona, 08003
SpainSite Not Available
Hospital Duran i Reynals
L'Hospitalet de Llobregat, 08907
SpainSite Not Available
Fundación Jiménez Díaz
Madrid, 28040
SpainSite Not Available
Hospital Clínico San Carlos
Madrid, 28040
SpainSite Not Available
Hospital Quirónsalud Madrid
Madrid, 28223
SpainSite Not Available
Hospital Universitario 12 de Octubre
Madrid, 28041
SpainSite Not Available
Hospital Universitario HM Sanchinarro
Madrid, 28050
SpainSite Not Available
Hospital Clínico de Santiago
Santiago de Compostela, 15706
SpainSite Not Available
Hospital Clínico de Valencia
Valencia, 46010
SpainSite Not Available
Karolinska Comprehensive Cancer Center
Stockholm, 171 76
SwedenSite Not Available
University Hospital Bern/Inselspital Bern
Bern, 3010
SwitzerlandSite Not Available
Taipei Veterans General Hospital
Taipei, 11217
TaiwanSite Not Available
Addenbrooke's Hospital
Cambridge, CB2 0QQ
United KingdomSite Not Available
The Royal Marsden Hospital, Chelsea
London, SW3 6JJ
United KingdomSite Not Available
Precision NextGen Oncology
Beverly Hills, California 90212
United StatesSite Not Available
Sarcoma Oncology Center
Santa Monica, California 90403
United StatesSite Not Available
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