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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06413706
Other study ID # 18646
Secondary ID I3Y-MC-JPEH2022-
Status Not yet recruiting
Phase Phase 2
First received
Last updated
Start date June 2024
Est. completion date February 2028

Study information

Verified date June 2024
Source Eli Lilly and Company
Contact There may be multiple sites in this clinical trial. 1-877-CTLILL
Phone 317-615-4559
Email ClinicalTrials.gov@lilly.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to measure the benefit of adding abemaciclib to the chemotherapy, temozolomide, for newly diagnosed high-grade glioma following radiotherapy. Your participation could last approximately 11 months and possibly longer depending upon how you and your tumor respond.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 45
Est. completion date February 2028
Est. primary completion date July 2027
Accepts healthy volunteers No
Gender All
Age group 0 Years to 20 Years
Eligibility Inclusion Criteria: - Biopsy proven high-grade glioma (HGG) as defined by 2016 World Health Organization (WHO) Classification Criteria, Grade 3-4 including: - Anaplastic astrocytoma - Anaplastic ganglioglioma - Anaplastic oligodendroglioma. - Anaplastic pleomorphic xanthoastrocytoma, - Glioblastoma OR as defined by the 2021 WHO Classification Criteria as molecularly characterized: - Non-pontine diffuse midline glioma, H3 K27-altered, - Diffuse hemispheric glioma, H3 G34-mutant - Diffuse pediatric HGG, H3/IDH-wildtype - Isocitrate dehydrogenase-mutant (IDH-mutant) Infant-type hemispheric glioma - High-grade astrocytoma with piloid features - High-grade pleomorphic xanthoastrocytoma - IDH-mutant diffuse glioma with homozygous cyclin- dependent kinase inhibitor 2A/B (CDKN2A/B) deletion, - IDH-mutant and 1p/19q co-deleted oligodendroglioma - IDH-mutant astrocytoma with homozygous CDKN2A/B deletion - Contraceptive use should be consistent with local regulations foe participants in clinical studies. - Radiotherapy initiated within 6 weeks (±1 week) of diagnosis and administered over 6 weeks (±1 week). Participants <3 years of age, considered not suitable for radiotherapy may be eligible. - Minimum of 4 weeks between completion of radiation and Cycle 1 Day 1 (C1D1). - Maximum of 8 weeks between completion of radiation and C1D1. Exceptional circumstances can be discussed with the medical monitor. - Acute effects of prior therapies must be Grade =1 unless deemed clinically insignificant by the investigator. - Adequate hematologic and organ function =7 days prior to C1D1 - Life expectancy of =8 weeks and deemed likely to complete at least 1 cycle of treatment. - A performance score of =60 using: 1. Lansky scale for participants <16 years 2. Karnofsky scale for participants =16 years - Able to swallow and/or have a gastric/nasogastric tube. - Any current systemic steroid use dose must be stable or decreasing at least 7 days prior to C1D1. - Able and willing to adhere to study procedures, including frequent blood draws and MRI. - At least 28 days since any major surgery, laparoscopic procedure, or a significant traumatic injury. Exclusion Criteria: Participants are excluded if any of the following apply: - Diffuse Intrinsic Pontine Glioma (DIPG) or diffuse midline glioma located in the pons. - Recurrent or refractory HGG including any recurrence/progression during/after radiotherapy. - Secondary HGG, defined as a previously treated low-grade glioma that now meets high- grade criteria, or that resulted from a previously treated malignancy. - Have known pathogenic somatic mutations appropriate for an anaplastic lymphoma kinase (ALK), B-rapidly accelerated fibrosarcoma (BRAF), or neurotrophic tyrosine receptor kinase (NTRK ) inhibitor, in regions where these therapies are available and deemed appropriate by the investigator. - Prior HGG treatment (including bevacizumab), except for surgery and radiotherapy (with or without concomitant temozolomide). - Current enrollment in another trial deemed incompatible with this study. - Treatment with an investigational product within the last 30 days or 5 half-lives (whichever is longer). - Prior malignancy within the previous 3 years that, per the investigator and the medical monitor, may affect interpretation of study results. - A preexisting medical condition(s) that, per the investigator, would preclude study participation. - Any serious, active, systemic infection requiring IV antibiotic, antifungal, or antiviral therapy, including acute hepatitis B or C, or Human Immunodeficiency Virus at C1D1. - Intolerability or hypersensitivity such as urticaria, anaphylaxis, toxic necrolysis, and/or Stevens-Johnson syndrome, to temozolomide, its excipients, or dacarbazine. - Received a live virus vaccine within 28 days of C1D1. - Pregnant, breastfeeding, or intend to become pregnant during the study.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Abemaciclib
Administered orally
Temozolomide
Administered orally or IV

Locations

Country Name City State
Belgium Cliniques universitaires Saint-Luc Brussels Bruxelles-Capitale
Belgium UZ Leuven Leuven Vlaams-Brabant
Denmark Rigshospitalet Copenhagen Hovedstaden
France Centre Leon Berard Lyon Rhône-Alpes
France Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone Marseille Bouches-du-Rhône
France Institut Curie Paris
France Gustave Roussy Villejuif Val-de-Marne
Italy IRCCS Istituto Giannina Gaslini Genova Liguria
Italy Fondazione IRCCS Istituto Nazionale dei Tumori Milan Lombardia
Italy Azienda Ospedaliera di Rilievo Nazional Santobono Pausilipon Napoli Campania
Italy Ospedale Pediatrico Bambino Gesù Rome Roma
Japan Osaka City General Hospital Osaka
Japan National Center for Child Health and Development Tokyo
Romania Institutul Oncologic Bucharest Bucure?ti
Romania Institutul Oncologic Cluj
Spain Hospital Universitari Vall d'Hebron Barcelona Barcelona [Barcelona]
Spain Hospital Sant Joan de Déu Esplugues de Llobregat Barcelona [Barcelona]
Spain Hospital Infantil Universitario Niño Jesús Madrid Madrid, Comunidad De
Spain Hospital Universitario La Paz Madrid
Spain Hospital Universitario Virgen Del Rocio Sevilla
Spain Hospital Universitari i Politecnic La Fe València
United States Johns Hopkins Hospital Baltimore Maryland
United States Children's Health Dallas Texas
United States Spectrum Health Grand Rapids Michigan
United States Nicklaus Children's Hospital Miami Florida
United States Children's Hospital of Orange County Orange California
United States Lucile Packard Children's Hospital Palo Alto California
United States Phoenix Childrens Hospital (PCH) Phoenix Arizona
United States Oregon Health and Science University Portland Oregon

Sponsors (1)

Lead Sponsor Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Belgium,  Denmark,  France,  Italy,  Japan,  Romania,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Event Free Survival as Determined by Blinded Independent Review Committee Event free survival as determined by blinded independent review committee. Baseline up to approximately 11 months
Secondary Event Free Survival as Determined by Investigator Assessment Event free survival as determined by investigator assessment Baseline up to approximately 11 months
Secondary Overall Survival (OS) Overall survival Baseline to date of death due to any cause (up to approximately 18 months)
Secondary Overall Response Rate (ORR) Overall response rate Baseline up to approximately 3 months
Secondary Disease Control Rate (DCR) Disease control rate Baseline through to disease progression (up to approximately 3 months )
Secondary Duration of Response (DoR) Duration of response Date of Complete Response (CR) or Partial Response (PR) or Minor Response (MR) to date of disease progression or death (up to approximately 3 months )
Secondary Pharmacokinetic (PK): Abemaciclib Plasma Concentration PK Abemaciclib Plasma Concentrations Cycle 1 through Cycle 4 (21 Day cycle)
Secondary Abemaciclib Acceptability and Palatability Questionnaire Questionnaire Day 1 of Cycles 1 through 3 (21 Day Cycles)]
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