Clinical trial • Phase II • Oncology
(3S,3'S,3A'S,10A'S)-6-CHLORO-3'-(3-CHLORO-2-FLUOROPHENYL)-1'-(CYCLOPROPYLMETHYL)-6'-METHYL-2-OXO-1,2,3',3A',10',10A'-HEXAHYDRO-1'H-SPIRO[INDOLE-3,2'-PYRROLO[2',3':4,5]PYRROLO[1,2-B]INDAZOLE]-7'-CARBOXYLIC ACID for Solid tumours
Phase II trial of (3S,3'S,3A'S,10A'S)-6-CHLORO-3'-(3-CHLORO-2-FLUOROPHENYL)-1'-(CYCLOPROPYLMETHYL)-6'-METHYL-2-OXO-1,2,3',3A',10',10A'-HEXAHYDRO-1'H-SPIRO…
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Solid tumours
- Trial Stage
- Phase II
- Drug Modality
- Small molecule
- Orphan Drug
- Yes
Key dates
- Initial CTIS Submission Date
- 19-07-2024
- First CTIS Authorization Date
- 23-10-2024
Trial design
open-label Phase II trial in Norway, Czechia, Poland and others.
- Open Label
- Yes
- Target Sample Size
- 62
Eligibility
Recruits 62 Vulnerable population not selected. Informed consent is required: "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." No specific assent/parental consent provisions for minors are indicated..
- Pregnancy Exclusion
- 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.
- Vulnerable Population
- Vulnerable population not selected. Informed consent is required: "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." No specific assent/parental consent provisions for minors are indicated.
Inclusion criteria
- {"criterion_text":"- Patient is ongoing on brigimadlin treatment in any trial sponsored by Boehringer Ingelheim (hereafter referred to as the ‘parent trial')."}
- {"criterion_text":"- 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."}
- {"criterion_text":"- 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."}
- {"criterion_text":"- Participants must be willing and able to comply with the scheduled visits, treatment plan, lifestyle, laboratory tests, contraceptive guidelines, and other study procedures."}
- {"criterion_text":"- Adequate organ function."}
- {"criterion_text":"- 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."}
Exclusion criteria
- {"criterion_text":"- Any medical condition which in the opinion of the investigator should exclude the patient from receiving treatment with brigimadlin."}
- {"criterion_text":"- Participants who must receive or intend to receive restricted medications or any drug considered likely to interfere with the safe conduct of the trial."}
- {"criterion_text":"- Patient unable to swallow the trial medication."}
- {"criterion_text":"- 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."}
- {"criterion_text":"- Patient has unacceptable toxicity on brigimadlin at the time of transition into this trial."}
- {"criterion_text":"- Patient has an AE which has caused a dose delay and has not recovered within the allowed time window in the parent trial."}
- {"criterion_text":"- 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 in writing between the investigator and the sponsor."}
- {"criterion_text":"- Further exclusion criteria apply."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Occurrence of treatment-emergent AEs according to CTCAE Version 5.0 during the entire treatment period","definition_or_measurement_approach":"Occurrence of treatment-emergent adverse events assessed according to CTCAE Version 5.0 during the entire treatment period."}
Recruitment
- Planned Sample Size
- 62
- Recruitment Window Months
- 144
- Consent Approach
- Provision of signed and dated, written informed consent form (ICF) in accordance with ICH-GCP and local legislation prior to any trial-specific procedures, sampling, or analyses. Multiple country-specific ICF documents and language versions are provided (local language ICFs and re-consent documents are listed in the trial documents).
Geography
- Total Number Of Sites
- 27
- Total Number Of Participants
- 31
Norway
- Earliest CTIS Part Ii Submission Date
- 09-05-2025
- Latest Decision Or Authorization Date
- 14-05-2025
- Processing Time Days
- 5
- Number Of Sites
- 1
- Number Of Participants
- 1
Sites
- Site Name
- Oslo University Hospital HF
- Department Name
- Radiumhospitalet
- Principal Investigator Name
- Kjetil Boye
- Principal Investigator Email
- pbk@ous-hf.no
- Contact Person Name
- Kjetil Boye
- Contact Person Email
- pbk@ous-hf.no
Czechia
- Earliest CTIS Part Ii Submission Date
- 26-05-2025
- Latest Decision Or Authorization Date
- 16-06-2025
- Processing Time Days
- 21
- Number Of Sites
- 1
- Number Of Participants
- 1
Sites
- Site Name
- University Hospital Olomouc
- Department Name
- Department of Comprehensive Oncology Care
- Principal Investigator Name
- Bohuslav Melichar
- Principal Investigator Email
- bohuslav.melichar@fnol.cz
- Contact Person Name
- Bohuslav Melichar
- Contact Person Email
- bohuslav.melichar@fnol.cz
Poland
- Earliest CTIS Part Ii Submission Date
- 28-05-2025
- Latest Decision Or Authorization Date
- 30-06-2025
- Processing Time Days
- 33
- Number Of Sites
- 1
- Number Of Participants
- 2
Sites
- Site Name
- Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
- Department Name
- Department of Early Phase Trials
- Principal Investigator Name
- Iwona Lugowska
- Principal Investigator Email
- iwona.lugowska@coi.pl
- Contact Person Name
- Iwona Lugowska
- Contact Person Email
- iwona.lugowska@coi.pl
Belgium
- Earliest CTIS Part Ii Submission Date
- 07-10-2024
- Latest Decision Or Authorization Date
- 29-10-2024
- Processing Time Days
- 22
- Number Of Sites
- 3
- Number Of Participants
- 2
Sites
- Site Name
- Cliniques Universitaires Saint-Luc
- Department Name
- Service d'oncologie medicale
- Principal Investigator Name
- Rachel Galot
- Principal Investigator Email
- rachel.galot@saintluc.uclouvain.be
- Contact Person Name
- Rachel Galot
- Contact Person Email
- rachel.galot@saintluc.uclouvain.be
- Site Name
- Antwerp University Hospital
- Principal Investigator Name
- Hans Prenen
- Principal Investigator Email
- Hans.Prenen@uza.be
- Contact Person Name
- Hans Prenen
- Contact Person Email
- Hans.Prenen@uza.be
- Site Name
- UZ Leuven
- Department Name
- Department of General Medical Oncology
- Principal Investigator Name
- Patrick Schöffski
- Principal Investigator Email
- patrick.schoffski@uzleuven.be
- Contact Person Name
- Patrick Schöffski
- Contact Person Email
- patrick.schoffski@uzleuven.be
France
- Earliest CTIS Part Ii Submission Date
- 11-06-2025
- Latest Decision Or Authorization Date
- 18-06-2025
- Processing Time Days
- 7
- Number Of Sites
- 2
- Number Of Participants
- 3
Sites
- Site Name
- Centre Leon Berard
- Department Name
- Oncologie Médicale
- Principal Investigator Name
- Jean-Yves Blay
- Principal Investigator Email
- jean-yves.blay@lyon.unicancer.fr
- Contact Person Name
- Jean-Yves Blay
- Contact Person Email
- jean-yves.blay@lyon.unicancer.fr
- Site Name
- Centre De Lutte Contre Le Cancer Eugene Marquis
- Department Name
- Service d'Oncologie Médicale
- Principal Investigator Name
- Christophe Perrin
- Principal Investigator Email
- c.perrin@rennes.unicancer.fr
- Contact Person Name
- Christophe Perrin
- Contact Person Email
- c.perrin@rennes.unicancer.fr
Denmark
- Earliest CTIS Part Ii Submission Date
- 19-06-2025
- Latest Decision Or Authorization Date
- 24-06-2025
- Processing Time Days
- 5
- Number Of Sites
- 1
- Number Of Participants
- 2
Sites
- Site Name
- Rigshospitalet
- Department Name
- Department of Oncology
- Principal Investigator Name
- Martin Hojgaard
- Principal Investigator Email
- martin.hojgaard@regionh.dk
- Contact Person Name
- Martin Hojgaard
- Contact Person Email
- martin.hojgaard@regionh.dk
Spain
- Earliest CTIS Part Ii Submission Date
- 06-08-2024
- Latest Decision Or Authorization Date
- 23-10-2024
- Processing Time Days
- 78
- Number Of Sites
- 12
- Number Of Participants
- 8
Sites
- Site Name
- Hospital Clinico San Carlos
- Department Name
- Servicio de Oncología Médica
- Principal Investigator Name
- Jorge Bartolomé
- Principal Investigator Email
- jorgebart@msn.com
- Contact Person Name
- Jorge Bartolomé
- Contact Person Email
- jorgebart@msn.com
- Site Name
- Hospital Universitario Quironsalud Madrid
- Department Name
- Unidad Fases I Next Oncology
- Principal Investigator Name
- Valentina Boni
- Principal Investigator Email
- vboni@nextoncology.eu
- Contact Person Name
- Valentina Boni
- Contact Person Email
- vboni@nextoncology.eu
- Site Name
- Institut Catala D'oncologia
- Department Name
- Unidad de Sarcoma y Cáncer Genitourinario
- Principal Investigator Name
- Laura Jiménez Colomo
- Principal Investigator Email
- ljcolomo@iconcologia.net
- Contact Person Name
- Laura Jiménez Colomo
- Contact Person Email
- ljcolomo@iconcologia.net
- Site Name
- Hospital Clinico Universitario De Valencia
- Department Name
- Servicio de Oncología Médica
- Principal Investigator Name
- Desamparados Roda
- Principal Investigator Email
- derope@hotmail.com
- Contact Person Name
- Desamparados Roda
- Contact Person Email
- derope@hotmail.com
- Site Name
- Hospital Quironsalud Barcelona
- Department Name
- Medicina Interna
- Principal Investigator Name
- Fabricio Racca Bussano
- Principal Investigator Email
- fracca@nextoncology.eu
- Contact Person Name
- Fabricio Racca Bussano
- Contact Person Email
- fracca@nextoncology.eu
- Site Name
- Hospital Universitario Miguel Servet
- Department Name
- Servicio Oncología
- Principal Investigator Name
- Javier Martínez Trufero
- Principal Investigator Email
- jmtrufero@seom.org
- Contact Person Name
- Javier Martínez Trufero
- Contact Person Email
- jmtrufero@seom.org
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Servicio de Oncologia
- Principal Investigator Name
- Jorge Adeva
- Principal Investigator Email
- jorge.adeva@salud.madrid.org
- Contact Person Name
- Jorge Adeva
- Contact Person Email
- jorge.adeva@salud.madrid.org
- Site Name
- Hospital Universitario Fundacion Jimenez Diaz
- Department Name
- Servicio de Oncología
- Principal Investigator Name
- Javier Martín Broto
- Principal Investigator Email
- jmartin@atbsarc.org
- Contact Person Name
- Javier Martín Broto
- Contact Person Email
- jmartin@atbsarc.org
- Site Name
- Hospital Del Mar
- Department Name
- Servicio de Oncologia
- Principal Investigator Name
- María Martínez García
- Principal Investigator Email
- mariamartinezgarcia@psmar.cat
- Contact Person Name
- María Martínez García
- Contact Person Email
- mariamartinezgarcia@psmar.cat
- Site Name
- Complexo Hospitalario Universitario De Santiago
- Department Name
- Servicio de Oncología Médica
- Principal Investigator Name
- Vanesa Varela
- Principal Investigator Email
- vanesa.varela.pose@sergas.es
- Contact Person Name
- Vanesa Varela
- Contact Person Email
- vanesa.varela.pose@sergas.es
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Oncologia
- Principal Investigator Name
- Teresa Macarulla
- Principal Investigator Email
- tmacarulla@vhio.net
- Contact Person Name
- Teresa Macarulla
- Contact Person Email
- tmacarulla@vhio.net
- Site Name
- Hospital Universitario Hm Sanchinarro
- Department Name
- Centro Integral Oncologico Clara Campal
- Principal Investigator Name
- Gema García Ledo
- Principal Investigator Email
- gmgarcialedo@hmhospitales.com
- Contact Person Name
- Gema García Ledo
- Contact Person Email
- gmgarcialedo@hmhospitales.com
Italy
- Earliest CTIS Part Ii Submission Date
- 25-04-2025
- Latest Decision Or Authorization Date
- 13-06-2025
- Processing Time Days
- 49
- Number Of Sites
- 2
- Number Of Participants
- 3
Sites
- Site Name
- Fondazione IRCCS Istituto Nazionale Dei Tumori
- Department Name
- Not applicable
- Principal Investigator Name
- Roberta Sanfilippo
- Principal Investigator Email
- roberta.sanfilippo@istitutotumori.mi.it
- Contact Person Name
- Roberta Sanfilippo
- Contact Person Email
- roberta.sanfilippo@istitutotumori.mi.it
- Site Name
- Istituto Oncologico Veneto
- Department Name
- Not applicable
- Principal Investigator Name
- Antonella Brunello
- Principal Investigator Email
- antonella.brunello@iov.veneto.it
- Contact Person Name
- Antonella Brunello
- Contact Person Email
- antonella.brunello@iov.veneto.it
Sweden
- Earliest CTIS Part Ii Submission Date
- 22-05-2025
- Latest Decision Or Authorization Date
- 13-06-2025
- Processing Time Days
- 22
- Number Of Sites
- 1
- Number Of Participants
- 1
Sites
- Site Name
- Karolinska University Hospital
- Department Name
- Comprehensive Cancer Center
- Principal Investigator Name
- Christina Linder-Stragliotto
- Principal Investigator Email
- christina.linder-stragliotto@sll.se
- Contact Person Name
- Christina Linder-Stragliotto
- Contact Person Email
- christina.linder-stragliotto@sll.se
Germany
- Earliest CTIS Part Ii Submission Date
- 02-06-2025
- Latest Decision Or Authorization Date
- 25-06-2025
- Processing Time Days
- 23
- Number Of Sites
- 2
- Number Of Participants
- 5
Sites
- Site Name
- HELIOS Klinikum Berlin-Buch GmbH
- Department Name
- Onkologie und Palliativmedizin
- Principal Investigator Name
- Peter Reichardt
- Principal Investigator Email
- peter.reichardt@helios-gesundheit.de
- Contact Person Name
- Peter Reichardt
- Contact Person Email
- peter.reichardt@helios-gesundheit.de
- Site Name
- Universitaetsklinikum Tuebingen AöR
- Department Name
- Innere Medizin VIII - Medizinische Onkologie und Pneumologie
- Principal Investigator Name
- Ulrich Lauer
- Principal Investigator Email
- ulrich.lauer@uni-tuebingen.de
- Contact Person Name
- Ulrich Lauer
- Contact Person Email
- ulrich.lauer@uni-tuebingen.de
Hungary
- Earliest CTIS Part Ii Submission Date
- 19-09-2024
- Latest Decision Or Authorization Date
- 06-11-2024
- Processing Time Days
- 48
- Number Of Sites
- 1
- Number Of Participants
- 3
Sites
- Site Name
- Clinexpert Kft.
- Department Name
- Dept of Oncology
- Principal Investigator Name
- Zsuzsanna Papai
- Principal Investigator Email
- trial.zspapai@gmail.com
- Contact Person Name
- Zsuzsanna Papai
- Contact Person Email
- trial.zspapai@gmail.com
Sponsor
Primary sponsor
- Full Name
- Boehringer Ingelheim International GmbH
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Germany
Investigational products
- Investigational Product Name
- BI 907828
- Active Substance
- (3S,3'S,3A'S,10A'S)-6-CHLORO-3'-(3-CHLORO-2-FLUOROPHENYL)-1'-(CYCLOPROPYLMETHYL)-6'-METHYL-2-OXO-1,2,3',3A',10',10A'-HEXAHYDRO-1'H-SPIRO[INDOLE-3,2'-PYRROLO[2',3':4,5]PYRROLO[1,2-B]INDAZOLE]-7'-CARBOXYLIC ACID
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- oral
- Orphan Designation
- Yes
- Dose Levels
- 30 mg | 45 mg
- Maximum Dose
- 45 mg
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