NCT06413706进行中（未招募）2 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 45
- 试验地点
- 89
- 主要终点
- Event Free Survival as Determined by Blinded Independent Review Committee
研究概览
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 0 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
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
- •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 C1D
- •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 C1D
- •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.
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.
- •Any serious, active, systemic infection requiring IV antibiotic, antifungal, or antiviral therapy, including acute hepatitis B or C, or Human Immunodeficiency Virus at C1D
- •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 C1D
- •Pregnant, breastfeeding, or intend to become pregnant during the study.
研究组 & 干预措施
Temozolomide - Arm B
Active Comparator
Participants will receive temozolomide administered orally or IV.
干预措施: Temozolomide (Drug)
Abemaciclib + Temozolomide - Arm A
Experimental
Participants will receive abemaciclib administered orally in addition to temozolomide administered orally or intravenously (IV).
干预措施: Abemaciclib (Drug)
Abemaciclib + Temozolomide - Arm A
Experimental
Participants will receive abemaciclib administered orally in addition to temozolomide administered orally or intravenously (IV).
干预措施: Temozolomide (Drug)
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)])
研究者
研究点 (89)
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