ONC201 for the Treatment of Newly Diagnosed H3 K27M-mutant Diffuse Glioma Following Completion of Radiotherapy: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study

Chimerix, Inc.0 个研究点目标入组 12 人开始时间: 待定最近更新: 2024年11月6日

试验速览

阶段: 不适用
状态: 招募中
发起方: Chimerix, Inc.
入组人数: 12

研究概览研究设计入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional
分配方式: Randomized Controlled Trial
干预模型: Parallel Assignment
主要目的: Treatment Purpose
盲法: Double Blind

入排标准

年龄范围: No limit 至 No limit（—）

入选标准

•Able to understand the study procedures and agree to participate in the study by providing written informed consent (by participant or legally authorized representative), and assent when applicable.
•Body weight >= 10 kg at time of randomization.
•Histologically diagnosed H3 K27M-mutant diffuse glioma (new diagnosis). Detection of a missense K27M mutation in any histone H3-encoding gene detected by testing of tumor tissue (immunohistochemistry [IHC] or NGS in a CLIA-certified or equivalent laboratory). [Site to provide (as available): >= 10 unstained formalin-fixed paraffin-embedded (FFPE) slides from tumor tissue.]
•At least one, high-quality, contrast-enhanced MRI of the brain obtained prior to starting radiotherapy for submission to sponsor's imaging vendor for central read. For participants who had a surgical resection, this scan must be post-resection; for participants who did not have a resection, this scan may be pre- or post-biopsy.
•At least one, high-quality, contrast-enhanced MRI of the brain obtained 2 to 6 weeks after completion of frontline radiotherapy. If unable to obtain contrast-enhanced imaging due to lack of venous access after multiple attempts, a patient may still be eligible after collection of a nonenhanced MRI of the brain. [Site to also provide all available MRIs completed prior to initiating treatment with study intervention.]
•Received frontline radiotherapy:
•A) Initiated radiotherapy within 12 weeks from the initial diagnosis of H3 K27M-mutant diffuse glioma.
•B) Completed radiotherapy within 2 to 6 weeks prior to randomization.
•C) Completed standard fractionated radiotherapy (eg, 54 to 60 Gy in 28 to 33 fractions given over approximately 6 weeks) or hypofractionated radiotherapy (eg, 40 Gy in 15 fractions given over approximately 3 weeks).
•Karnofsky Performance Status or Lansky Performance Status >= 70 at time of randomization.
•Stable or decreasing dose of corticosteroids and anti-seizure medications for 7 days prior to randomization, if applicable. Stable steroid dose is defined as <= 2 mg/day increase (based on dexamethasone dose or equivalent dose of alternative steroid).

排除标准

•Primary spinal tumor.
•Diffuse intrinsic pontine glioma (DIPG), defined as tumors with a pontine epicenter and diffuse involvement of the pons.
•Evidence of leptomeningeal spread of disease or cerebrospinal fluid dissemination.
•Any known concurrent malignancy.
•New lesion(s) outside of the radiation field.
•Received whole-brain radiotherapy.
•Received proton therapy for glioma.
•Use of any of the following treatments within the specified time periods prior to randomization:
•A) ONC201 or ONC206 at any time.
•B) Systemic bevacizumab (includes biosimilars) at any time since initial diagnosis of H3 K27M-mutant diffuse glioma.
•C) Temozolomide within past 3 weeks.
•D) Tumor treating fields at any time.
•E) DRD2 antagonist within past 2 weeks.
•F) Any investigational therapy within past 4 weeks.
•G) Strong CYP3A4 inhibitors within 3 days.
•H) Strong CYP3A4 inducers within 2 weeks.
•Laboratory test results meeting any of the following parameters within 2 weeks prior to randomization:
•A) Absolute neutrophil count <1.0 x 10^9/L or platelets < 75 x 10^9/L.
•B) Total bilirubin > 1.5 x ULN (participants with Gilbert's syndrome may be included with total bilirubin > 1.5 x ULN if direct bilirubin is <=1.5 x ULN).
•C) Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.5 x ULN.
•D) Creatinine clearance <= 60 mL/min as calculated by the Cockcroft Gault equation (or estimated glomerular filtration rate < 60 mL/min/1.73 m^2).
•QTc > 480 msec (based on mean from triplicate electrocardiograms [ECGs]) during screening.
•Known hypersensitivity to any excipients used in the study intervention formulation.
•Pregnant, breastfeeding, or planning to become pregnant while receiving study intervention or within 3 months after the last dose. Participants of childbearing potential must have a negative serum pregnancy test within 72 hours prior to receiving the first dose of study intervention.
•Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring systemic therapy or psychiatric illness/social situations that would limit compliance with study requirements.
•Any other condition (eg, medical, psychiatric, or social) that, in the opinion of the investigator, may interfere with participant safety or the ability to complete the study according to the protocol.

研究者

发起方

Chimerix, Inc.

相似试验

招募中

1 期

The ACTION Study: ONC201 in H3 K27M-mutant Diffuse Glioma Following Radiotherapy

CTIS2022-502051-56-00Chimerix Inc.450

招募中

3 期

ONC201 in H3 K27M-mutant Diffuse Glioma Following Radiotherapy (the ACTION Study)H3 K27MGlioma

NCT05580562Jazz Pharmaceuticals510

进行中（未招募）

1 期

A study in patients with idiopathic hypersomnia involving two parts. Part A is an an open-label study to assess safety, tolerability and pharmacokinetics of a single oral GR3027 dose in female patients. Part B is a randomized, double-blind, placebo-controlled crossover study to assess safety, tolerability, exposure and exploratory efficacy of multiple oral doses of GR3027 in male and female IH patients.Idiopathic hypersomnia (IH)MedDRA version: 20.0Level: HLTClassification code 10028714Term: Narcolepsy and hypersomniaSystem Organ Class: 100000004852

EUCTR2017-002127-16-DKmecrine Cognition AB20

进行中（未招募）

1 期

EUCTR2017-002127-16-FImecrine Cognition AB20

进行中（未招募）

1 期

EUCTR2017-002127-16-SEmecrine Cognition AB20