A Study Comparing Abemaciclib Plus Temozolomide to Temozolomide Monotherapy in Children and Young Adults With High-grade Glioma Following Radiotherapy (I3Y-MC-JPEH)
A Study Comparing Abemaciclib Plus Temozolomide to Temozolomide Monotherapy for Pediatric High-grade Glioma (I3Y-MC-JPEH)
Masaki Takeshi
Eli Lilly Japan K.K.
5-1-28, Isogamidori, Chuo-ku, Kobe, Hyogo
+81-120-023-812
LTG_CallCenter@lists.lilly.com
Trial Guide Call Center
Eli Lilly Japan K.K.
5-1-28, Isogamidori, Chuo-ku, Kobe, Hyogo
+81-120-023-812
LTG_CallCenter@lists.lilly.com
Not Recruiting
Sept. 10, 2024
Mar. 03, 2025
6
Interventional
randomized controlled trial
open(masking not used)
active control
parallel assignment
treatment purpose
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 <3 years of age, considered not suitable for radiotherapy may be eligible.
-Minimum of 4 weeks between completion of radiation and date of initial treatment (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:
a) Lansky scale for participants <16 years
b) 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 or over.
-Capable of giving sign on informed consent form or assent
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.
No limit
21age old not
High-Grade Glioma
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
Event Free Survival as determined by Blinded Independent Review Committee
-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
Eli Lilly Japan K.K.
Osaka City General Hospital Institutional Review Board
2-13-22, Miyakojimahondori, Osaka Shi Miyakojima Ku, Osaka, Osaka
