High-Grade Glioma
Conditions
Interventions
Drug: Abemaciclib
Administered orally
Other Names: LY2835219
Drug: Temozolomide
Administered orally or IV (If approved by medical monitor)
Arm A: Abemaciclib + Temozolomide
Arm B: Temozolomide
Sponsors
Masaki Takeshi
Eligibility
Inclusion criteria
Inclusion criteria: Subjects required to meet all the folloiwng 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 -Isocitrate dehydrogenase-mutant (IDH-mutant) 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 -Patients who consent to use effective methods of contraception which meets the study criteria. -Radiotherapy initiated within 6 weeks (+-1 week) of diagnosis and administered over 6 weeks (+-1 week). Participants =8 weeks and deemed likely to complete at least 1 cycle of treatment. -A performance score of >=60 using: a) Lansky 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 or over. -Capable of giving sign on informed consent form or assent
Exclusion criteria
Exclusion criteria: Patients who meets any of the following criteria cannot participate in this clinical trial. -Diffuse Intrinsic Pontine Glioma (DIPG) or diffuse midline glioma located in the ? -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. -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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Event Free Survival as determined by Blinded Independent Review Committee | — |
Secondary
| Measure | Time frame |
|---|---|
| -Event Free Survival as determined by investigator assessment -Overall Survival -Overall Response Rate -Disease Control Rate -Duration of Response -Safety -Abemaciclib Plasma Concentrations -Participant and/or caregiver reported acceptability and palatability | — |
Countries
Australia, Belgium, Denmark, France, Italy, Japan, Netherlands, Romania, Spain, the US
Contacts
Public ContactTrial Guide Call Center
Eli Lilly Japan K.K.
Outcome results
None listed