Phase
Condition
Neoplasms
All Solid Tumors
Treatment
Brigimadlin
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion criteria:
Patient is ongoing on brigimadlin treatment in any trial sponsored by BoehringerIngelheim (hereafter referred 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.
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.
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.
Patient has unacceptable toxicity on brigimadlin at the time of transition into thistrial.
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 in writing between theinvestigator and the sponsor.
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
Prince of Wales Hospital-Randwick-66496
Randwick 2208285, New South Wales 2155400 2031
AustraliaSite Not Available
Princess Alexandra Hospital
Woolloongabba, Queensland 4102
AustraliaSite Not Available
Princess Alexandra Hospital
Woolloongabba 6943568, Queensland 2152274 4102
AustraliaSite Not Available
Peter MacCallum Cancer Centre
Melbourne, Victoria 3000
AustraliaSite Not Available
Cliniques Universitaires Saint-Luc
Brussels, 1200
BelgiumSite Not Available
Cliniques Universitaires Saint-Luc
Brussels 2800866, 1200
BelgiumSite 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
UZ Leuven
Leuven 2792482, 3000
BelgiumSite Not Available
H.S.J. Beneficência Portuguesa - São Paulo
Sao Paulo, 01323-001
BrazilSite Not Available
H.S.J. Beneficência Portuguesa - São Paulo
São Paulo 3448439, 01323-001
BrazilSite Not Available
Arthur J. E. Child Comprehensive Cancer Centre
Calgary, Alberta T2N 5G2
CanadaSite Not Available
Arthur J. E. Child Comprehensive Cancer Centre
Calgary 5913490, Alberta 5883102 T2N 5G2
CanadaSite Not Available
Princess Margaret Cancer Centre
Toronto, Ontario M5G 2M9
CanadaSite Not Available
Princess Margaret Cancer Centre
Toronto 6167865, Ontario 6093943 M5G 2M9
CanadaSite Not Available
West China Hospital
Chengdu, 610041
ChinaSite Not Available
Sun Yat-Sen University Cancer Center
Guangzhou, 510060
ChinaSite Not Available
Sun Yat-Sen University Cancer Center
Guangzhou 1809858, 510060
ChinaSite Not Available
Wuhan Union Hospital
Wuhan, 430022
ChinaSite Not Available
University Hospital Olomouc
Olomouc, 77900
CzechiaSite Not Available
University Hospital Olomouc
Olomouc 3069011, 77900
CzechiaSite Not Available
Copenhagen University Hospital, Rigshospitalet
København Ø, 2100
DenmarkSite Not Available
Copenhagen University Hospital, Rigshospitalet
København Ø 11746747, 2100
DenmarkSite Not Available
CTR Leon Berard
Lyon, 69373
FranceSite Not Available
CTR Leon Berard
Lyon 2996944, 69373
FranceSite Not Available
CTR Eugène Marquis
Rennes, 35042
FranceSite Not Available
CTR Eugène Marquis
Rennes 2983990, 35042
FranceSite Not Available
Helios Klinikum Berlin-Buch
Berlin, 13125
GermanySite Not Available
Helios Klinikum Berlin-Buch
Berlin 2950159, 13125
GermanySite Not Available
Universitätsklinikum Frankfurt
Frankfurt, 60590
GermanySite Not Available
Universitätsklinikum Tübingen
Tübingen, 72076
GermanySite Not Available
Universitätsklinikum Tübingen
Tübingen 2820860, 72076
GermanySite Not Available
Clinexpert Gyongyos
Gyongyos, 3200
HungarySite Not Available
Clinexpert Gyongyos
Gyöngyös, 3200
HungarySite Not Available
Clinexpert Gyongyos
Gyöngyös 3052040, 3200
HungarySite Not Available
Sourasky Medical Center
Tel Aviv, 6423906
IsraelSite Not Available
Sourasky Medical Center
Tel Aviv 293397, 6423906
IsraelSite Not Available
Sourasky Medical Center
Tel-Aviv, 6423906
IsraelSite Not Available
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, 20133
ItalySite Not Available
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan 6951411, 20133
ItalySite 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
Istituto Oncologico Veneto IRCCS
Padua, 35128
ItalySite Not Available
Istituto Oncologico Veneto IRCCS
Padua 3171728, 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
JapanSite Not Available
Nederlands Kanker Instituut
Amsterdam, 1066 CX
NetherlandsSite Not Available
Oslo Universitetssykehus HF, Radiumhospitalet
Oslo, N-0379
NorwaySite Not Available
Oslo Universitetssykehus HF, Radiumhospitalet
Oslo 3143244, N-0379
NorwaySite Not Available
Oncology Center-Maria Sklodowska-Curie Institute
Warsaw, 02-781
PolandSite Not Available
Oncology Center-Maria Sklodowska-Curie Institute
Warsaw 756135, 02-781
PolandSite Not Available
Hospital Miguel Servet
Aragon, 50009
SpainActive - Recruiting
Hospital Universitario Miguel Servet
Aragon, 50009
SpainSite 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
Fundación Jiménez Díaz
Madrid 3117735, 28040
SpainActive - Recruiting
Hospital Universitario 12 de Octubre
Madrid 3117735, 28041
SpainSite Not Available
Hospital Universitario HM Sanchinarro
Madrid 3117735, 28050
SpainActive - Recruiting
Hospital Clínico de Santiago
Santiago de Compostela, 15706
SpainSite Not Available
Hospital Clínico de Santiago
Santiago de Compostela 3109642, 15706
SpainSite Not Available
Hospital Clínico de Valencia
Valencia, 46010
SpainSite Not Available
Karolinska Comprehensive Cancer Center
Stockholm, SE-171 76
SwedenSite Not Available
Karolinska Comprehensive Cancer Center
Stockholm 2673730, SE-171 76
SwedenSite Not Available
University Hospital Bern/Inselspital Bern
Bern, 3010
SwitzerlandSite Not Available
Taipei Veterans General Hospital
Taipei, 11217
TaiwanSite Not Available
Taipei Veterans General Hospital
Taipei 1668341, 11217
TaiwanSite Not Available
Addenbrooke's Hospital
Cambridge, CB2 0QQ
United KingdomSite Not Available
Addenbrooke's Hospital
Cambridge 2653941, CB2 0QQ
United KingdomSite Not Available
The Royal Marsden Hospital, Chelsea
London, SW3 6JJ
United KingdomSite Not Available
University College Hospital
London, NW12PQ
United KingdomSite Not Available
The Royal Marsden Hospital, Chelsea
London 2643743, SW3 6JJ
United KingdomSite Not Available
University College Hospital
London 2643743, NW12PQ
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
Precision NextGen Oncology
Beverly Hills 5328041, California 5332921 90212
United StatesSite Not Available
Sarcoma Oncology Center
Santa Monica 5393212, California 5332921 90403
United StatesSite Not Available
Yale Cancer Center
New Haven, Connecticut 06511
United StatesSite Not Available
Yale Cancer Center
New Haven 4839366, Connecticut 4831725 06511
United StatesSite Not Available
Mayo Clinic Cancer Center
Jacksonville, Florida 32224
United StatesSite Not Available
Mayo Clinic Cancer Center
Jacksonville 4160021, Florida 4155751 32224
United StatesSite Not Available
Northwestern University
Chicago, Illinois 60611
United StatesSite Not Available
Dana-Farber Cancer Institute
Boston, Massachusetts 02215
United StatesSite Not Available
Washington University School of Medicine
Saint Louis, Missouri 63108
United StatesSite Not Available
Washington University School of Medicine
St Louis, Missouri 63108
United StatesSite Not Available
Washington University School of Medicine
St Louis 4407066, Missouri 4398678 63108
United StatesSite Not Available
Nebraska Cancer Specialists-Omaha-69066
Omaha, Nebraska 68130
United StatesSite Not Available
Nebraska Cancer Specialists-Omaha-69066
Omaha 5074472, Nebraska 5073708 68130
United StatesSite Not Available
Northwell Health
Lake Success, New York 11042
United StatesSite Not Available
Memorial Sloan-Kettering Cancer Center
New York, New York 10065
United StatesSite Not Available
Northwell Health
Lake Success 5123853, New York 5128638 11042
United StatesSite Not Available
West Cancer Center & Research Institute
Germantown, Tennessee 38138
United StatesSite Not Available
Henry-Joyce Cancer Clinic
Nashville, Tennessee 37232
United StatesSite Not Available
West Cancer Center & Research Institute
Germantown 4624601, Tennessee 4662168 38138
United StatesSite Not Available
Henry-Joyce Cancer Clinic
Nashville 4644585, Tennessee 4662168 37232
United StatesSite Not Available
The University of Texas MD Anderson Cancer Center
Houston, Texas 77030
United StatesSite Not Available
The University of Texas MD Anderson Cancer Center
Houston 4699066, Texas 4736286 77030
United StatesSite Not Available
Utah Cancer Specialists Cancer Center
Salt Lake City, Utah 84106
United StatesSite Not Available
Utah Cancer Specialists Cancer Center
Salt Lake City 5780993, Utah 5549030 84106
United StatesSite Not Available
Fred Hutchinson Cancer Research Center
Seattle, Washington 98109
United StatesSite Not Available
Fred Hutchinson Cancer Research Center
Seattle 5809844, Washington 5815135 98109
United StatesSite Not Available
University of Wisconsin
Madison, Wisconsin 53792
United StatesSite Not Available
University of Wisconsin
Madison 5261457, Wisconsin 5279468 53792
United StatesSite Not Available

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