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

Study Identifier:
I3Y-MC-JPEH
CT.gov Identifier:
NCT06413706
EudraCT Identifier:
202250000000
EU Trial (CTIS) Number:
2022-502269-13-00
Study Contact Information:
(210) 593-5651 or [email protected]
Recruitment Complete

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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.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Glioma
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    II
    Sex
    Female & Male
    Age
    N/A - 20 Years
    Study Drug
  • Drug: Experimental: Abemaciclib + Temozolomide - Arm A
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  • Drug: Drug: Abemaciclib
  • Drug: Drug: Temozolomide
  • Drug: Active Comparator: Temozolomide - Arm B
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruitment Complete

    Requirements information
    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:
    • 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.
    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.

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Madrid, Spain (CIOCC)
    Madrid, Spain, 28050
    Investigator
    Marta Osuna
    Status
    Recruitment Complete
    Condition(s) Treated at Site
    Glioma