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GliomaPhase 2NCT06413706

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

A Phase 2 study testing Abemaciclib and Temozolomide in people with Glioma, run by Eli Lilly and Company at 37 sites in 10 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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. Read more about this study

Who is it for?
Ages 0 to 20 years
Conditions the study is for
Glioma
What is being tested?
Abemaciclib and Temozolomide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
37 sitesin 10 countries
Study dates
25 Oct 2024to Feb 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 0 to 20 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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
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  • 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:
  • Lansky scale for participants <16 years
  • 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.

Who cannot join

  • 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).
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  • 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.

Trial locations and contacts

37 sites in 10 countries.

37 sites in 10 countries

United States9 sites

  • University of Michigan Health System (UMHS) - C.S. Mott Children's Hospital - Hematology Oncology Clinic

    Ann Arbor, Michigan, 48109

  • The Johns Hopkins Hospital (JHH) - Johns Hopkins Childrens Center

    Baltimore, Maryland, 21287

  • UT Southwestern Medical Center Dallas/Childrens Medical Center

    Dallas, Texas, 75235

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • Riley Hospital for Children at Indiana University Health

    Indianapolis, Indiana, 46202

  • Children's Hospital of Orange County - Orange

    Orange, California, 92868

  • Lucile Packard Children's Hospital (LPCH) - Stanford University

    Palo Alto, California, 94304

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • Mayo Clinic

    Rochester, Minnesota, 55905

Other trials in United States

France6 sites

  • Centre Hospitalier Universitaire de Bordeaux Groupe Hospitalier Pellegrin Hopital des Enfants

    Bordeaux, 33076

  • Centre de Lutte Contre le Cancer (CLCC) - Centre Oscar Lambret

    Lille, 59020

  • Centre Leon Berard

    Lyon, 69008

  • Hopital La Timone

    Marseille, 13885

  • Institut Curie

    Paris, 75005

  • Institut Gustave Roussy-Gustave Roussy Cancer Center -DITEP

    Villejuif, 94805

Other trials in France

Spain6 sites

  • Hospital Universitario Vall d'Hebron

    Barcelona, 08035

  • Hospital Universitario Reina Sofia

    Córdoba, 14004

  • Hospital Clinico San Carlos

    Esplugues de Llobregat, 08950

  • Hospital Infantil Universitario Nino Jesus (HIUNJS)

    Madrid, 28009

  • Hospital Universitario Virgen Del Rocio

    Seville, 41013

  • Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur)

    Valencia, 46026

Other trials in Spain

Italy4 sites

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, 20133

  • Azienda Ospedaliera Di Rilievo Nazionale Santobono Pausilipon

    Naples, 80129

  • IRCCS Ospedale Pediatrico Bambino Gesu

    Rome, 00165

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Universita Cattolica del Sacro Cuore

    Rome, 00168

Other trials in Italy

Australia3 sites

  • Queensland Government- Lady Cilento Children's Hospital

    Brisbane, 4101

  • Perth Children's Hospital

    Nedlands, 6009

  • The Children's Hospital at Westmead

    Westmead, 2145

Other trials in Australia

Belgium3 sites

  • Universitair Ziekenhuis Gent (Uz Gent)

    Ghent, 9000

  • Universitair Ziekenhuis Leuven

    Leuven, 3000

  • Universite Catholique de Louvain (UCL) - Cliniques Universitaires Saint-Luc

    Woluwe-Saint-Lambert, 1200

Other trials in Belgium

Japan3 sites

  • Nagoya University Hospital

    Nagoya, 466-8560

  • Osaka City General Hospital

    Osaka, 534-0021

  • National Center for Child Health and Development (NCCHD)

    Setagaya-Ku Tokyo, 157-8535

Other trials in Japan

Denmark1 site

  • Copenhagen University Hospital-Rigshospitalet University Hospital

    Copenhagen, 2100

Other trials in Denmark

Netherlands1 site

  • Princess Maxima Center for Voor Kinderoncologie B.V

    Utrecht, 3584 CS

Other trials in Netherlands

Romania1 site

  • Institutul Oncologic Prof. Dr. Ion Chiricuta

    Cluj-Napoca, 400015

Other trials in Romania

About this study

Official title: A Randomized, Open-Label, Phase 2 Study Evaluating Abemaciclib in Combination With Temozolomide Compared to Temozolomide Monotherapy in Children and Young Adults With Newly Diagnosed High-Grade Glioma Following Radiotherapy

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.

Conditions
Glioma
Keywords
Brain tumor, Central nervous system (CNS) tumor, Spinal cord tumor, Cyclin-dependent kinase (CDK) 4/6 inhibitor
Medical subject headings
Glioma, Brain Neoplasms, Neoplasms, Spinal Cord Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06413706
Study groupRoleWhat they receive
Abemaciclib + Temozolomide - Arm AExperimentalParticipants will receive abemaciclib administered orally in addition to temozolomide administered orally or intravenously (IV).
Receives: Drug: Abemaciclib; Drug: Temozolomide
Temozolomide - Arm BActive comparatorParticipants will receive temozolomide administered orally or IV.
Receives: Drug: Temozolomide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Event Free Survival as Determined by Blinded Independent Review Committee

    Event free survival as determined by blinded independent review committee.

    Measured: Baseline up to approximately 11 months

Secondary outcomes (7)

  1. Event Free Survival as Determined by Investigator Assessment

    Event free survival as determined by investigator assessment

    Measured: Baseline up to approximately 11 months

  2. Overall Survival (OS)

    Overall survival

    Measured: Baseline to date of death due to any cause (up to approximately 18 months)

  3. Overall Response Rate (ORR)

    Overall response rate

    Measured: Baseline up to approximately 3 months

  4. Disease Control Rate (DCR)

    Disease control rate

    Measured: Baseline through to disease progression (up to approximately 3 months )

  5. Duration of Response (DoR)

    Duration of response

    Measured: 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 )

  6. Pharmacokinetic (PK): Abemaciclib Plasma Concentration

    PK Abemaciclib Plasma Concentrations

    Measured: Cycle 1 through Cycle 4 (21 Day cycle)

  7. Abemaciclib Acceptability and Palatability Questionnaire

    Participants evaluated abemaciclib acceptability (palatability and ease of administration) using a 5-category questionnaire. Participants were asked to select one of the following to describe the acceptability of abemaciclib: Very difficult, difficult, neither easy nor difficult, easy, or very easy.

    Measured: Day 1 of Cycles 1 through 3 (21 Day Cycles)]

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 May 2024
  2. Study start25 Oct 2024
  3. Primary completionFeb 2027 (estimated)
  4. Study completionFeb 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
45 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06413706
Sponsor's protocol ID
18646
Other IDs
I3Y-MC-JPEH, 2022-502269-13-00, U1111-1289-0405
Status last verified
Jul 2026
First submitted
9 May 2024
Last updated
17 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Abemaciclib and Temozolomide in people with Glioma, run by Eli Lilly and Company at 37 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 31 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in United States, France, Spain, Italy, Australia and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Event Free Survival as Determined by Blinded Independent Review Committee (time frame: Baseline up to approximately 11 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06413706.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.

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