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 Radiotherapy

Eli Lilly and Company89 个研究点分布在 9 个国家目标入组 45 人2024年10月25日

适应症Glioma

干预措施Abemaciclib Temozolomide

概览

阶段: 2 期
干预措施: Abemaciclib
疾病 / 适应症: Glioma
发起方: Eli Lilly and Company
入组人数: 45
试验地点: 89
主要终点: Event Free Survival as Determined by Blinded Independent Review Committee
状态: 进行中（未招募）
最后更新: 12天前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

概览

简要总结

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.

注册库

clinicaltrials.gov

开始日期

2024年10月25日

结束日期

2028年2月1日

最后更新

12天前

研究类型

Interventional

研究设计

Parallel

性别

All

研究者

发起方

Eli Lilly and Company

责任方

Sponsor

入排标准

入选标准

•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

排除标准

•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.

研究组 & 干预措施

Abemaciclib + Temozolomide - Arm A

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

干预措施: Abemaciclib

Abemaciclib + Temozolomide - Arm A

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

干预措施: Temozolomide

Temozolomide - Arm B

Participants will receive temozolomide administered orally or IV.

干预措施: Temozolomide

结局指标

主要结局

Event Free Survival as Determined by Blinded Independent Review Committee

时间窗: Baseline up to approximately 11 months

Event free survival as determined by blinded independent review committee.

次要结局

Overall Response Rate (ORR)(Baseline up to approximately 3 months)
Overall Survival (OS)(Baseline to date of death due to any cause (up to approximately 18 months))
Event Free Survival as Determined by Investigator Assessment(Baseline up to approximately 11 months)
Disease Control Rate (DCR)(Baseline through to disease progression (up to approximately 3 months ))
Duration of Response (DoR)(Date of Complete Response (CR) or Partial Response (PR) or Minor Response (MR) to date of disease progression or death (up to approximately 3 months ))
Pharmacokinetic (PK): Abemaciclib Plasma Concentration(Cycle 1 through Cycle 4 (21 Day cycle))
Abemaciclib Acceptability and Palatability Questionnaire(Day 1 of Cycles 1 through 3 (21 Day Cycles)])