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PIPELINE > TRIAL OVERVIEW

Trial Information
Molecule Overview
CDK4/6 Inhibitor
Abemaciclib
Phase
2
Recruiting

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 Radiotherapya

Related Resources:
Molecule Overview Trial Enrollment
NCT06413706 Trial Schema show modal icon
Key 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
Key Exclusion Criteria
  • 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
a
This clinical trial is being conducted in Australia, Belgium, Denmark, France, Italy, Japan, Netherlands, Romania, Spain, and the United States.
b
Administered orally. 
c
Administered intravenously.
For information on trial enrollment, locations, and more, call 1-800-545-5979.
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