Safety and Efficacy Study of Safusidenib in Participants With IDH1-Mutant Glioma Who Discontinued Vorasidenib Treatment Due to Progressive Disease
Grade 2 IDH1-mutant Glioma · Grade 3 IDH1-mutant Glioma · Glioma · IDH1-mutant Glioma · Oligodendroglioma · Oligodendroglioma IDH-1 Mutant and 1/p19q-codeleted · Astrocytoma IDH Mutant Grade 3 · Astrocytoma IDH Mutant Grade 2
De qué trata este estudio
El registro indica que este estudio recluta participantes. La disponibilidad puede variar por centro.
- Tipo de estudio
- De intervención
- Fase
- Fase 2
- Rango de edad
- 18 años - No especificado
- Sexo admitido
- Todos los sexos
- Voluntarios sanos
- No aceptados
- Participantes
- 40 Estimado
Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.
Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.
Acerca de la investigación
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.
¿Quién podría participar?
La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.
Key Inclusion Criteria:
- 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
Key Exclusion Criteria:
- 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.
Tratamiento, grupos y participación
El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.
- Asignación
- No aplica
- Enmascaramiento
- Sin enmascaramiento
Safusidenib
Safusidenib 250 mg BID
Drug: Safusidenib
Safusidenib DRUG
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.
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
Objective Response Rate (ORR) per modified Response Assessment in Neuro-Oncology (RANO) 2.0 assessed by Blinded Independent Central Review (BICR)
Plazo: From the date of first dose of study drug until the date of first documented disease progression, approximately 18 months
ORR defined as the proportion of participants with the confirmed best overall response of Complete Response (CR), Partial Response (PR) or Minor Response (MR) per modified RANO 2.0, assessed by BICR
Medidas secundarias
ORR per modified RANO 2.0 assessed by Investigator
Plazo: From the date of first dose of study drug until the date of first documented disease progression, approximately 18 months
ORR defined as the proportion of participants with the confirmed best overall response of CR, PR or MR per modified RANO 2.0, assessed by the Investigator
Volumetric Tumor Growth Rate (TGR) by BICR
Plazo: From historical scans through the final scan in the study, approximately 18 months
TGR defined as the percentage change in tumor volume by unit of time, assessed by BICR
Duration of Response (DOR) per modified RANO 2.0 assessed by BICR and by Investigator
Plazo: From the date of first dose of study drug until the date of first documented disease progression, approximately 18 months
DOR, time from the first documentation of objective response (CR, PR, or MR) to the date of the first occurrence of radiographic disease progression per modified RANO 2.0 assessed by BICR and by the Investigator or death from any cause, whichever occurs earlier.
Time to Next Intervention (TTNI)
Plazo: 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
TTNI, defined as the time from the first dose of study drug to the initiation of first subsequent anticancer therapy or death from any cause, whichever occurs earlier
Progression Free Survival (PFS) per modified RANO 2.0 assessed by BICR and by Investigator
Plazo: From the date of first dose of study drug until the date of first documented disease progression, approximately 18 months
PFS, defined as the time from the first dose of study drug to the date of the first occurrence of radiographic disease progression per modified RANO 2.0 assessed by BICR and by the Investigator or death from any cause, whichever occurs earlier.
Time to Response (TTR) per modified RANO 2.0 assessed by BICR and by Investigator
Plazo: From the date of first dose of study drug to the first documentation of objective response (CR, PR, or MR), approximately 18 months
TTR, defined as the time from the first dose of study drug to the first documentation of objective response (CR, PR, or MR) per modified RANO 2.0, assessed by BICR and by the Investigator
Overall Survival (OS)
Plazo: From the date of first dose of study drug until the date of death, approximately 18 months
OS, defined as the time from the first dose of study drug to death from any cause.
Safety and tolerability
Plazo: 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
The safety and tolerability of safusidenib evaluated based on AEs graded by NCI-CTCAE version 5.0, laboratory abnormalities as graded by NCI-CTCAE version 5.0, vital signs, physical examinations, and ECGs
Seizure Activity
Plazo: From the date of first dose of study drug until the date of first documented disease progression, approximately 18 months
Evaluate seizure frequencies and severity including type of seizure, seizure-related AEs, and changes in anti-epileptic medications in participants receiving safusidenib
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (12)
El estado general puede diferir del estado de un centro. Confirma la disponibilidad antes de trasladarte.
12 centros
University of California, Los AngelesLos Angeles, California, United StatesAún no recluta
University of California, San FranciscoSan Francisco, California, United StatesAún no recluta
Yale UniversityNew Haven, Connecticut, United StatesAún no recluta
University of Miami HealthMiami, Florida, United StatesAún no recluta
Indiana UniversityIndianapolis, Indiana, United StatesReclutando
LSU LCMC Health Cancer CenterNew Orleans, Louisiana, United StatesAún no recluta
Massachusetts General HospitalBoston, Massachusetts, United StatesAún no recluta
Rutgers Cancer InstituteNew Brunswick, New Jersey, United StatesAún no recluta
NYU Langone HealthNew York, New York, United StatesReclutando
Columbia University Medical CenterNew York, New York, United StatesAún no recluta
Cleveland ClinicCleveland, Ohio, United StatesAún no recluta
The Ohio State University Comprehensive Cancer CenterColumbus, Ohio, United StatesAún no recluta
Equipo y fechas
- Patrocinador principal
- Nuvation Bio Inc.
- Inicio del estudio
- 2027-03 Estimado
- Finalización primaria
- 2030-09 Estimado
- Finalización del estudio
- 2032-03 Estimado
- Primera publicación
- 14 jul 2026 Real
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
Título oficial del estudio
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
Consulta a Wellness Clinical Research
Tu mensaje va a WCR, incluso si otra organización realiza este estudio. WCR puede orientarte, pero podría no realizar este estudio, tener acceso a su equipo ni poder inscribirte.
Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 12 nov 2026 · Última actualización del registro: 10 nov 2026