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Clinical Trials in the USA / NCT06413706
Active, not recruiting Phase 2

A Study Comparing Abemaciclib Plus Temozolomide to Temozolomide Monotherapy in Children and Young Adults With High-grade Glioma Following Radiotherapy

NCT06413706 · tracked via the Priya Life Science USA tracker
Sponsor
Eli Lilly and Company
Phase
Phase 2
Started
2024-10-25
Last updated
2026-07-17

Condition(s) studied

Glioma

Investigational drug(s) / intervention(s)

Abemaciclib →Temozolomide →

Abemaciclib: Administered orally

Temozolomide: Administered orally or IV

Study 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.

Eligibility

Sex
ALL
Min age
0 Years
Max age
20 Years
Healthy volunteers
No
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 * 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 for 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. * Has a body surface area (BSA) of ≥0.2 m2. 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, and/or abemaciclib, their excipients, or dacarbazine. * Received a live virus vaccine within 28 days of C1D1. * Pregnant, breastfeeding, or intend to become pregnant during the study.

Primary outcome measure(s)

Trial sites (37)

FacilityCityRegionStatus
Children's Hospital of Orange County - Orange Orange California
Lucile Packard Children's Hospital (LPCH) - Stanford University Palo Alto California
Riley Hospital for Children at Indiana University Health Indianapolis Indiana
The Johns Hopkins Hospital (JHH) - Johns Hopkins Childrens Center Baltimore Maryland
University of Michigan Health System (UMHS) - C.S. Mott Children's Hospital - Hematology Oncology Clinic Ann Arbor Michigan
Mayo Clinic Rochester Minnesota
Rhode Island Hospital Providence Rhode Island
UT Southwestern Medical Center Dallas/Childrens Medical Center Dallas Texas
The University of Texas MD Anderson Cancer Center Houston Texas
Queensland Government- Lady Cilento Children's Hospital Brisbane Australia
Perth Children's Hospital Nedlands Australia
The Children's Hospital at Westmead Westmead Australia
Universitair Ziekenhuis Gent (Uz Gent) Ghent Belgium
Universitair Ziekenhuis Leuven Leuven Belgium
Universite Catholique de Louvain (UCL) - Cliniques Universitaires Saint-Luc Woluwe-Saint-Lambert Belgium
Copenhagen University Hospital-Rigshospitalet University Hospital Copenhagen Denmark
Centre Hospitalier Universitaire de Bordeaux Groupe Hospitalier Pellegrin Hopital des Enfants Bordeaux France
Centre de Lutte Contre le Cancer (CLCC) - Centre Oscar Lambret Lille France
Centre Leon Berard Lyon France
Hopital La Timone Marseille France
Institut Curie Paris France
Institut Gustave Roussy-Gustave Roussy Cancer Center -DITEP Villejuif France
Fondazione IRCCS Istituto Nazionale dei Tumori Milan Italy
Azienda Ospedaliera Di Rilievo Nazionale Santobono Pausilipon Naples Italy
IRCCS Ospedale Pediatrico Bambino Gesu Rome Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Universita Cattolica del Sacro Cuore Rome Italy
Nagoya University Hospital Nagoya Japan
Osaka City General Hospital Osaka Japan
National Center for Child Health and Development (NCCHD) Setagaya-Ku Tokyo Japan
Princess Maxima Center for Voor Kinderoncologie B.V Utrecht Netherlands
Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj-Napoca Romania
Hospital Universitario Vall d'Hebron Barcelona Spain
Hospital Universitario Reina Sofia Córdoba Spain
Hospital Clinico San Carlos Esplugues de Llobregat Spain
Hospital Infantil Universitario Nino Jesus (HIUNJS) Madrid Spain
Hospital Universitario Virgen Del Rocio Seville Spain
Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur) Valencia Spain

On this site

📄 Verzenio (abemaciclib) drug profile →

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06413706 on ClinicalTrials.gov ↗ ← All trials in the USA