Clinical trial • Phase II • Oncology
ABEMACICLIB for High-grade glioma | Glioma
Phase II trial of ABEMACICLIB for High-grade glioma | Glioma.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- High-grade glioma | Glioma
- Trial Stage
- Phase II
- Drug Modality
- Small molecule
- Paediatric Trial
- Yes
Key dates
- Initial CTIS Submission Date
- 29-04-2024
- First CTIS Authorization Date
- 05-08-2024
Trial design
Randomised, open-label, intervention: abemaciclib + temozolomide (abemaciclib - oral formulations listed including verzenios 50 mg film-coated tablets; product information lists max daily dose amount 400 mg). comparator arm: temozolomide monotherapy (temozolomide, oral; product information lists dose unit mg/m2 and max daily dose amount 200 mg/m2).-controlled Phase II trial in Romania, Netherlands, Denmark and others.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Intervention: Abemaciclib + Temozolomide (Abemaciclib - oral formulations listed including Verzenios 50 mg film-coated tablets; product information lists max daily dose amount 400 mg). Comparator arm: Temozolomide monotherapy (TEMOZOLOMIDE, oral; product information lists dose unit mg/m2 and max daily dose amount 200 mg/m2).
- Target Sample Size
- 30
Eligibility
Recruits 30 paediatric patients.
- Pregnancy Exclusion
- Be pregnant or breastfeeding
- Vulnerable Population
- Vulnerable population selected: children and young adults. Age-appropriate assent and consent procedures are provided (multiple age-specific assent forms and parental/guardian consent forms are included in the documentation). Subject information and consent/assent materials are prepared for different age groups (e.g., assent 2-6 years, 7-11 years, 12-14 years, 15-17 years, parental/guardian consent, adult main forms) and are available in multiple languages as indicated in the trial documentation.
Inclusion criteria
- {"criterion_text":"- Participants must:\n- Have high-grade glioma\n- Have had prior radiotherapy with or without temozolomide (patients less than 3 years old without prior radiotherapy may be eligible)\n- Have recovered from major side effects of previous therapy and have adequate organ function and blood counts, as measured by lab tests\n- Be able to swallow or have a feeding tube\n- Be willing and able to follow study procedures, including frequent lab tests and tumor imaging"}
Exclusion criteria
- {"criterion_text":"- Participants must not:\n- Have glioma that came back or started growing again after receiving treatment\n- Have received other therapy for this cancer, except surgery and radiotherapy (with or without temozolomide)\n- Have certain alterations in their tumor that can be treated with a different therapy\n- Have acute infections or any serious medical conditions (other than this cancer)\n- Be pregnant or breastfeeding"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Event Free Survival as Determined by Blinded Independent Review Committee","definition_or_measurement_approach":"Event Free Survival as Determined by Blinded Independent Review Committee"}
Recruitment
- Planned Sample Size
- 30
- Recruitment Window Months
- 44
- Consent Approach
- Informed consent obtained from adult participants and from parents/legal guardians for minors. Age-appropriate assent forms are provided for younger participants (documents for age groups including 2-6 years, 7-11 years, 12-14 years, 15-17 years, and 16+ forms). Parental/guardian consent and partner/pregnant-partner forms are available. Consent and assent materials are provided in multiple languages (examples in the documentation include English, French, Dutch, Romanian and others).
Methods
- Posters (K2_Poster) – patient-facing posters for clinic/hospital display in multiple languages.
- Patient letters (K2_Patient Letter) – direct patient information letters used for recruitment/contact.
- Appointment reminder cards (K2_Appointment Reminder Card) – appointment reminders for participants.
- Healthcare professional (HCP) letters (K2_HCP Letter) – information to HCPs to support recruitment.
- Brochures and study visit guides (K2_Brochure, K2_Study Visit Guide) – informational materials for patients and families.
- Recruitment procedure and ICF documents (K1_ICF and Patient Recruitment Procedure, L1_SIS-ICF documents) – structured recruitment and consent processes; materials prepared country-specific and in multiple languages.
Geography
- Total Number Of Sites
- 33
- Total Number Of Participants
- 30
Romania
- Earliest CTIS Part Ii Submission Date
- 13-02-2025
- Latest Decision Or Authorization Date
- 17-03-2025
- Processing Time Days
- 32
- Number Of Sites
- 2
- Number Of Participants
- 2
Sites
- Site Name
- Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti
- Department Name
- Sectia Oncologie Pediatrica
- Principal Investigator Name
- Monica Desiree Dragomir
- Principal Investigator Email
- md.dragomir@gmail.com
- Contact Person Name
- Monica Desiree Dragomir
- Contact Person Email
- md.dragomir@gmail.com
- Site Name
- Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
- Department Name
- Sectia Oncopediatrie
- Principal Investigator Name
- Rodica Cosnarovici
- Principal Investigator Email
- office@iocn.ro
- Contact Person Name
- Rodica Cosnarovici
- Contact Person Email
- office@iocn.ro
Netherlands
- Earliest CTIS Part Ii Submission Date
- 16-04-2025
- Latest Decision Or Authorization Date
- 24-04-2025
- Processing Time Days
- 8
- Number Of Sites
- 1
- Number Of Participants
- 2
Sites
- Site Name
- Prinses Maxima Centrum voor Kinderoncologie B.V.
- Department Name
- Neuro-oncology
- Principal Investigator Name
- Jasper Van der Lugt
- Principal Investigator Email
- j.vanderlugt@prinsesmaximacentrum.nl
- Contact Person Name
- Jasper Van der Lugt
- Contact Person Email
- j.vanderlugt@prinsesmaximacentrum.nl
Denmark
- Earliest CTIS Part Ii Submission Date
- 17-02-2025
- Latest Decision Or Authorization Date
- 21-02-2025
- Processing Time Days
- 4
- Number Of Sites
- 1
- Number Of Participants
- 2
Sites
- Site Name
- Rigshospitalet
- Department Name
- Department of Paediatrics and Adolescent Medicine
- Principal Investigator Name
- Mimi Kjaersgaard
- Principal Investigator Email
- mimi.kjaersgaard@regionh.dk
- Contact Person Name
- Mimi Kjaersgaard
- Contact Person Email
- mimi.kjaersgaard@regionh.dk
Italy
- Earliest CTIS Part Ii Submission Date
- 31-07-2024
- Latest Decision Or Authorization Date
- 12-08-2024
- Processing Time Days
- 12
- Number Of Sites
- 8
- Number Of Participants
- 8
Sites
- Site Name
- Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
- Department Name
- SC Pediatric Oncoematology
- Principal Investigator Name
- Nicoletta Bertorello
- Principal Investigator Email
- nbertorello@cittadellasalute.it
- Contact Person Name
- Nicoletta Bertorello
- Contact Person Email
- nbertorello@cittadellasalute.it
- Site Name
- IRCCS Istituto Giannina Gaslini
- Department Name
- Department of Hemato-Oncology
- Principal Investigator Name
- Claudia Milanaccio
- Principal Investigator Email
- claudiamilanaccio@gaslini.org
- Contact Person Name
- Claudia Milanaccio
- Contact Person Email
- claudiamilanaccio@gaslini.org
- Site Name
- Fondazione IRCCS Istituto Nazionale Dei Tumori
- Department Name
- Pediatric Oncology Unit
- Principal Investigator Name
- Veronica Biassoni
- Principal Investigator Email
- Veronica.biassoni@istitutotumori.mi.it
- Contact Person Name
- Veronica Biassoni
- Contact Person Email
- Veronica.biassoni@istitutotumori.mi.it
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- UO Oncologia Pediatrica
- Principal Investigator Name
- Antonio Ruggiero
- Principal Investigator Email
- antonio.ruggiero@policlinicogemelli.it
- Contact Person Name
- Antonio Ruggiero
- Contact Person Email
- antonio.ruggiero@policlinicogemelli.it
- Site Name
- Istituto Oncologico Veneto
- Department Name
- Medical Oncology 1 Unit
- Principal Investigator Name
- Giuseppe Lombardi
- Principal Investigator Email
- giuseppe.lombardi@iov.veneto.it
- Contact Person Name
- Giuseppe Lombardi
- Contact Person Email
- giuseppe.lombardi@iov.veneto.it
- Site Name
- L’Azienda Ospedaliera Di Rilievo Nazionale Santobono-Pausilipon
- Department Name
- UOSD Neuroncology
- Principal Investigator Name
- Lucia Quaglietta
- Principal Investigator Email
- l.quaglietta@santobonopausilipon.it
- Contact Person Name
- Lucia Quaglietta
- Contact Person Email
- l.quaglietta@santobonopausilipon.it
- Site Name
- Bambino Gesu Childrens Hospital
- Department Name
- Neuro-Oncology Unit
- Principal Investigator Name
- Angela Mastronuzzi
- Principal Investigator Email
- Angela.mastronuzzi@opbg.net
- Contact Person Name
- Angela Mastronuzzi
- Contact Person Email
- Angela.mastronuzzi@opbg.net
- Site Name
- Istituto Oncologico Veneto (additional listing)
- Department Name
- Pediatric/Oncology-related unit (other listings present)
Belgium
- Earliest CTIS Part Ii Submission Date
- 23-07-2024
- Latest Decision Or Authorization Date
- 06-08-2024
- Processing Time Days
- 14
- Number Of Sites
- 4
- Number Of Participants
- 3
Sites
- Site Name
- Cliniques Universitaires Saint-Luc
- Department Name
- Pediatric hemato-oncology department
- Principal Investigator Name
- An Van Damme
- Principal Investigator Email
- An.vandamme@saintluc.uclouvain.be
- Contact Person Name
- An Van Damme
- Contact Person Email
- An.vandamme@saintluc.uclouvain.be
- Site Name
- Universitair Ziekenhuis Gent
- Department Name
- Pediatric hemato- oncology department
- Principal Investigator Name
- Leen Willems
- Principal Investigator Email
- Leen.willems@uzgent.be
- Contact Person Name
- Leen Willems
- Contact Person Email
- Leen.willems@uzgent.be
- Site Name
- Centre Hospitalier Regional De La Citadelle
- Department Name
- Pediatric hemato-oncology department
- Principal Investigator Name
- Rose-Marie Silvestre
- Principal Investigator Email
- Rose-marie.silvestre@citadelle.be
- Contact Person Name
- Rose-Marie Silvestre
- Contact Person Email
- Rose-marie.silvestre@citadelle.be
- Site Name
- UZ Leuven
- Department Name
- Pediatric hemato-oncology department
- Principal Investigator Name
- Sandra Jacobs
- Principal Investigator Email
- Sandra2.jacobs@uzleuven.be
- Contact Person Name
- Sandra Jacobs
- Contact Person Email
- Sandra2.jacobs@uzleuven.be
France
- Earliest CTIS Part Ii Submission Date
- 24-07-2024
- Latest Decision Or Authorization Date
- 05-08-2024
- Processing Time Days
- 12
- Number Of Sites
- 8
- Number Of Participants
- 6
Sites
- Site Name
- Centre Hospitalier Regional De Marseille
- Department Name
- Service d’immunologie, hématologie et oncologie pédiatrique
- Principal Investigator Name
- Andre Nicolas
- Principal Investigator Email
- Nicolas.andre@ap-hm.fr
- Contact Person Name
- Andre Nicolas
- Contact Person Email
- Nicolas.andre@ap-hm.fr
- Site Name
- Centre Hospitalier Universitaire De Bordeaux
- Department Name
- Paediatric onco-haematology unit
- Principal Investigator Name
- Celine Icher
- Principal Investigator Email
- Celine.icher@chu-bordeaux.fr
- Contact Person Name
- Celine Icher
- Contact Person Email
- Celine.icher@chu-bordeaux.fr
- Site Name
- Centre Leon Berard
- Department Name
- IHOPe (Institute of Hematology and Pediatric Oncology)
- Principal Investigator Name
- Pierre Leblond
- Principal Investigator Email
- Pierre.leblond@ihope.fr
- Contact Person Name
- Pierre Leblond
- Contact Person Email
- Pierre.leblond@ihope.fr
- Site Name
- Centre Hospitalier Universitaire D'Angers
- Department Name
- Pediatric Oncology
- Principal Investigator Name
- Claire Brisset
- Principal Investigator Email
- Claire.brisset@chu-angers.fr
- Contact Person Name
- Claire Brisset
- Contact Person Email
- Claire.brisset@chu-angers.fr
- Site Name
- Institut Curie
- Department Name
- SIREDO(Soins, Innovation, Recherche, en oncologie de l’Enfant, de l’aDOlescent et de l’adulte jeune)
- Principal Investigator Name
- Isabelle Aerts
- Principal Investigator Email
- Isabelle.aerts@curie.fr
- Contact Person Name
- Isabelle Aerts
- Contact Person Email
- Isabelle.aerts@curie.fr
- Site Name
- CHRU De Nancy
- Department Name
- Paediatric onco-haematology unit
- Principal Investigator Name
- Marie-Sophie Merlin
- Principal Investigator Email
- M.MERLIN@chru-nancy.fr
- Contact Person Name
- Marie-Sophie Merlin
- Contact Person Email
- M.MERLIN@chru-nancy.fr
- Site Name
- Centre Oscar Lambret
- Department Name
- Pediatric unit, oncology department
- Principal Investigator Name
- Sandra Raimbault
- Principal Investigator Email
- s-raimbault@o-lambret.fr
- Contact Person Name
- Sandra Raimbault
- Contact Person Email
- s-raimbault@o-lambret.fr
- Site Name
- Institut Gustave Roussy
- Department Name
- Children and adolescent oncology
- Principal Investigator Name
- Samuel Abbou
- Principal Investigator Email
- Samuel.ABBOU@gustaveroussy.fr
- Contact Person Name
- Samuel Abbou
- Contact Person Email
- Samuel.ABBOU@gustaveroussy.fr
Spain
- Earliest CTIS Part Ii Submission Date
- 29-07-2024
- Latest Decision Or Authorization Date
- 09-08-2024
- Processing Time Days
- 11
- Number Of Sites
- 9
- Number Of Participants
- 7
Sites
- Site Name
- University Clinical Hospital Virgen De La Arrixaca
- Department Name
- Oncología pediatrica
- Principal Investigator Name
- Irene Jiménez García
- Principal Investigator Email
- irene.jimenez@carm.es
- Contact Person Name
- Irene Jiménez García
- Contact Person Email
- irene.jimenez@carm.es
- Site Name
- Hospital Universitario Reina Sofia
- Department Name
- Servicio de Pediatría
- Principal Investigator Name
- Maria Elena Mateos Gonzalez
- Principal Investigator Email
- mariae.mateos.sspa@juntadeandalucia.es
- Contact Person Name
- Maria Elena Mateos Gonzalez
- Contact Person Email
- mariae.mateos.sspa@juntadeandalucia.es
- Site Name
- Hospital Infantil Universitario Nino Jesus
- Department Name
- Servicio de Onco-Hematología Pediátrica
- Principal Investigator Name
- Alvaro Lassaletta Atienza
- Principal Investigator Email
- alvaro.lassaletta@salud.madrid.org
- Contact Person Name
- Alvaro Lassaletta Atienza
- Contact Person Email
- alvaro.lassaletta@salud.madrid.org
- Site Name
- Hospital Universitario La Paz
- Department Name
- Hemato-Oncología Pediátrica y TPH
- Principal Investigator Name
- Diego Plaza Lopez de Sabando
- Principal Investigator Email
- diego_dea@yahoo.es
- Contact Person Name
- Diego Plaza Lopez de Sabando
- Contact Person Email
- diego_dea@yahoo.es
- Site Name
- Sant Joan De Deu Barcelona Hospital
- Department Name
- Unidad de Neuro-Oncología
- Principal Investigator Name
- Miriam Pavón Mengual
- Principal Investigator Email
- miriam.pavon@sjd.es
- Contact Person Name
- Miriam Pavón Mengual
- Contact Person Email
- miriam.pavon@sjd.es
- Site Name
- Hospital Universitario Y Politecnico La Fe
- Department Name
- Unidad Oncohematología Pediátrica
- Principal Investigator Name
- Antonio Juan Ribelles
- Principal Investigator Email
- juan_antrib@gva.es
- Contact Person Name
- Antonio Juan Ribelles
- Contact Person Email
- juan_antrib@gva.es
- Site Name
- University Hospital Virgen Del Rocio S.L.
- Department Name
- Oncología pediatrica
- Principal Investigator Name
- Palma Solano Paez
- Principal Investigator Email
- palma.solano.sspa@juntadeandalucia.es
- Contact Person Name
- Palma Solano Paez
- Contact Person Email
- palma.solano.sspa@juntadeandalucia.es
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Servei d’Oncologia i Hematologia Pediatrica
- Principal Investigator Name
- Anna Llort Sales
- Principal Investigator Email
- anna.llort@vallhebron.cat
- Contact Person Name
- Anna Llort Sales
- Contact Person Email
- anna.llort@vallhebron.cat
- Site Name
- Hospital Universitario Hm Monteprincipe
- Department Name
- Pediatric Oncology Unit
- Principal Investigator Name
- Marta Pilar Osuna Marco
- Principal Investigator Email
- Marta.Osuna@startmadrid.com
- Contact Person Name
- Marta Pilar Osuna Marco
- Contact Person Email
- Marta.Osuna@startmadrid.com
Sponsor
Primary sponsor
- Full Name
- Eli Lilly & Co.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- Icon Clinical Research Limited
- Responsibilities
- codes:1,10,11,12,13,15 (Home Health (collection of blood samples from patients)), 15 (Imaging),2,4,5,6,7
- Name
- PPD Development L.P.
- Responsibilities
- code 10
- Name
- Altasciences Compagnie Inc.
- Responsibilities
- code 4
- Name
- Labcorp Early Development Laboratories Inc.
- Responsibilities
- code 4
- Name
- Q2 Solutions LLC
- Responsibilities
- code 4
Third parties
- {"country":"United States","full_name":"Jumo Health USA Inc.","duties_or_roles":"Medical Education","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"patient reimbursement","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Canada","full_name":"Altasciences Compagnie Inc.","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
- {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"codes:1,10,11,12,13,15 (Home Health (collection of blood samples from patients)), 15 (Imaging),2,4,5,6,7","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"RWS Life Sciences Inc.","duties_or_roles":"Redaction and Translations","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"PPD Development L.P.","duties_or_roles":"code 10","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Labcorp Early Development Laboratories Inc.","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Q2 Solutions LLC","duties_or_roles":"code 4","organisation_type":"Laboratory/Research/Testing facility"}
Investigational products
- Investigational Product Name
- Abemaciclib (including Verzenios 50 mg film-coated tablets and other Abemaciclib formulations listed)
- Active Substance
- ABEMACICLIB
- Modality
- Small molecule
- Routes Of Administration
- Oral
- Route
- Oral
- Authorisation Status
- Marketing authorisation exists for Verzenios 50 mg (EU/1/18/1307/001); other Abemaciclib formulations also listed for use in the trial
- Maximum Dose
- 400 mg daily (maxDailyDoseAmount listed)
- Investigational Product Name
- Temozolomide
- Active Substance
- TEMOZOLOMIDE
- Modality
- Small molecule
- Routes Of Administration
- Oral
- Route
- Oral
- Authorisation Status
- Authorised
- Maximum Dose
- 200 mg/m2 daily (maxDailyDoseAmount listed as 200 mg/m2)
- Combination Treatment
- Yes
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