Safety and Efficacy Study of Safusidenib in Participants With IDH1-Mutant Glioma Who Discontinued Vorasidenib Treatment Due to Progressive Disease

Официальное название

A Phase 2, Multicenter, Clinical Study to Evaluate the Efficacy and Safety of Safusidenib Erbumine in Participants With Isocitrate Dehydrogenase 1 (IDH1)-Mutant Glioma Who Discontinued Vorasidenib Treatment Due to Progressive Disease

Обзор

This study will include up to 40 participants with Grade 2 or Grade 3 IDH1-mutant glioma who have undergone surgery and received vorasidenib as their only treatment, experienced radiographic disease progression on vorasidenib (confirmed by Blinded Independent Central Review \[BICR\] per modified Response Assessment in Neuro-Oncology \[RANO\] 2.0), and are not in need of immediate chemotherapy or radiotherapy.

Вмешательства

• Препарат Safusidenib
  Safusidenib administered twice daily as a single agent orally on Days 1 to 28 of a 28-day cycle. Participants may continue treatment until disease progression or another reason for discontinuation occurs.

Первичные конечные точки

• Objective Response Rate (ORR) per modified Response Assessment in Neuro-Oncology (RANO) 2.0 assessed by Blinded Independent Central Review (BICR) [Срок оценки: From the date of first dose of study drug until the date of first documented disease progression, approximately 18 months]

Вторичные конечные точки (9)

• ORR per modified RANO 2.0 assessed by Investigator [Срок оценки: From the date of first dose of study drug until the date of first documented disease progression, approximately 18 months]
• Volumetric Tumor Growth Rate (TGR) by BICR [Срок оценки: From historical scans through the final scan in the study, approximately 18 months]
• Duration of Response (DOR) per modified RANO 2.0 assessed by BICR and by Investigator [Срок оценки: From the date of first dose of study drug until the date of first documented disease progression, approximately 18 months]
• Time to Next Intervention (TTNI) [Срок оценки: From the date of first dose of study drug until the date of the start of another anticancer treatment or date of death, approximately 18 months]
• Progression Free Survival (PFS) per modified RANO 2.0 assessed by BICR and by Investigator [Срок оценки: From the date of first dose of study drug until the date of first documented disease progression, approximately 18 months]
• Time to Response (TTR) per modified RANO 2.0 assessed by BICR and by Investigator [Срок оценки: From the date of first dose of study drug to the first documentation of objective response (CR, PR, or MR), approximately 18 months]
• Overall Survival (OS) [Срок оценки: From the date of first dose of study drug until the date of death, approximately 18 months]
• Safety and tolerability [Срок оценки: From the date of first dose of study drug until 30 days after the date of the last dose of study drug, approximately 18 months]
• Seizure Activity [Срок оценки: From the date of first dose of study drug until the date of first documented disease progression, approximately 18 months]

Критерии участия

Критерии включения

• Histologically confirmed Grade 2 or 3 IDH-mutant astrocytoma or IDH-mutant and 1p19q co-deleted oligodendroglioma, according to WHO CNS 2021 criteria
• IDH1 mutation (e.g., R132H/C/G/S/L) based on immunohistochemistry (IHC) (R132H only), PCR, or next generation sequencing (NGS).
• Have had at least 1 prior surgery for glioma (biopsy, sub-total resection, or gross total resection).
• Measurable disease per modified RANO 2.0 confirmed by BICR during Screening.
• Previously treated with vorasidenib and experienced radiographic disease progression during treatment and are not in need of immediate chemotherapy or radiotherapy in the opinion of the Investigator. Disease progression must be confirmed by BICR using modified RANO 2.0.
• Adequate hematologic and organ function
• Expected survival of ≥12 months

Критерии исключения

• Any prior anticancer therapy other than surgery (biopsy, sub-total, or gross total resection) and vorasidenib for treatment of glioma.
• Discontinued vorasidenib for toxicity or any reason other than radiographic disease progression
• Prior treatment with anti-angiogenic agents such as Avastin (bevacizumab) or investigational agents for glioma.
• Brainstem or spinal cord involvement either as primary location, site of multifocal involvement, or by significant tumor extension.
• Significant functional or neurocognitive deficits, including uncontrolled seizures
• Evidence of leptomeningeal disease.
• Use of therapeutic doses of steroids for signs/symptoms of glioma. Participants taking physiologic doses (defined as equivalent of <1.5 mg of dexamethasone equivalent) for medical conditions not related to glioma will be permitted.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07703436 · NUV-218-G209

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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