NCT05518838No Longer Available不适用
Expanded Access to OKN-007 for Patients With Diffuse Midline Glioma, H3 K27-altered
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- No Longer Available
- 发起方
- Oblato, Inc.
- 试验地点
- 9
研究概览
简要总结
To provide OKN-007 for compassionate use in patients with diffuse midline glioma, H3 K27-altered (DMG), including diffuse intrinsic pontine glioma (DIPG), pediatric and young adult patients with high-grade diffuse midline glioma will be treated under this Intermediate-sized expanded access treatment protocol.
研究设计
- 研究类型
- Expanded Access
入排标准
- 年龄范围
- 13 Months 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age from > 12 months to ≤ 18 years of age at the time of enrollment.
- •Diagnosis of diffuse midline glioma, H3 K27-altered according to the WHO 2021 Classification of Tumors of the Central Nervous System diagnostic criteria including diffuse intrinsic pontine glioma (DIPG). In the absence of a pathologically confirmed diagnosis, a grade IV glioma involving the thalamus, hypothalamus, brainstem, cerebellum, midbrain, or spinal cord, or with a pontine epicenter and diffuse involvement of the pons.
- •Patient has completed definitive radiation therapy as part of standard-of-care treatment or was unable to undergo radiation.
- •Karnofsky performance status ≥ 50 for patients ≥ 16 years of age and Lansky performance status ≥ 50 for patients < 16 years of age; patients who are unable to walk because of paralysis, but who are upright in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.
- •Patients must have adequate bone marrow, liver, and renal function:
- •For females of childbearing potential, negative urinary or serum pregnancy test.
- •Patients must be willing to highly effective contraception for both male and female patients throughout the treatment and for at least 4 months after last treatment administration.
- •Toxicities related to any prior treatments are either stable, stable on supportive therapy, resolved, or in the opinion of the treating physician, clinically non-significant
- •Ability to understand a written informed consent document, and the willingness to sign it. Assent will be obtained when appropriate based on the patient's age.
排除标准
- •Patient is already participating in or qualifies for and is able to enroll in a clinical trial of OKN-007 and other ongoing clinical trials.
- •Patient has received systemic therapy with an investigational agent within 5 half-lives or 14 days prior to starting OKN-007 treatment, whichever is shorter.
- •Patients completing radiotherapy treatment less than 14 days prior to planned study treatment initiation.
- •Current evidence of uncontrolled, significant intercurrent illness that would, in the treating physician's judgment, contraindicate the patient's treatment with OKN-007 due to safety concerns.
- •Patients who, in the opinion of the treating physician, have not fully recovered from recent major surgery to a sufficient extent to tolerate treatment with OKN-
- •Known hypersensitivity to OKN-007 or any component in its formulation.
- •Patients taking prohibited medications as described in the current Investigator's Brochure.
- •Patient is pregnant or actively breastfeeding.
研究者
研究点 (9)
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