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

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

Study Purpose

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 Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	0 Years - 20 Years
Gender	All

More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06413706
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Eli Lilly and Company
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Contact Lilly at 1-800-LillyRx (1-800-545-5979)
Principal Investigator Affiliation	Eli Lilly and Company
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Australia, Belgium, Denmark, France, Italy, Japan, Netherlands, Romania, Spain, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Glioma

Arms & Interventions

Arms

Experimental: Abemaciclib + Temozolomide - Arm A

Participants will receive abemaciclib administered orally in addition to temozolomide administered orally or intravenously (IV).

Active Comparator: Temozolomide - Arm B

Participants will receive temozolomide administered orally or IV.

Interventions

Drug: - Abemaciclib

Administered orally

Drug: - Temozolomide

Administered orally or IV

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Phoenix Children's Hospital, Phoenix, Arizona

Status

Not yet recruiting

Address

Phoenix Children's Hospital

Phoenix, Arizona, 85016

Site Contact

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