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Safety and Efficacy Study of Safusidenib in Participants With Grade 2 IDH1-Mutant Glioma

14 luglio 2026 aggiornato da: Nuvation Bio Inc.

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Safusidenib in Participants With Grade 2 Isocitrate Dehydrogenase 1 (IDH1)-Mutant Glioma

This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter study comparing the efficacy and safety of safusidenib versus placebo in participants with residual or recurrent Grade 2 glioma (oligodendroglioma or astrocytoma) with an IDH1 mutation who have undergone surgery as their only treatment and are not in need of immediate chemotherapy or radiotherapy.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

140

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Key Inclusion Criteria:

  • Expected survival of ≥12 months.
  • At least 1 prior surgery for glioma (biopsy, sub-total resection, or gross total resection), with the most recent surgery having occurred at least 90 days (or at least 28 days if biopsy only and postoperative changes have resolved per BICR) and no longer than 5 years before the date of randomization
  • Have not had any other prior anticancer therapy, including chemotherapy and radiotherapy; and are not in need of immediate chemotherapy or radiotherapy in the opinion of the Investigator.
  • Histologically confirmed Grade 2, IDH1-mutant oligodendroglioma or astrocytoma according to World Health Organization Central Nervous System 2021 classification criteria per Investigator assessment.
  • IDH1 mutation (R132H/C/G/S/L), identified by polymerase chain reaction, next-generation sequencing (NGS), or immunohistochemistry; and confirmed 1p19q codeletion status by fluorescence in situ hybridization, NGS, or array comparative genomic hybridization.
  • Residual or recurrent, measurable, non-enhancing disease, as confirmed by BICR per RANO 2.0, assessed at Screening.
  • Adequate hematologic and organ functions

Key Exclusion Criteria:

  • Any prior anticancer therapy other than surgery (biopsy, sub-total, or gross total resection) for treatment of glioma, including chemotherapy, investigational therapies, prior therapies targeting IDH1 or IDH2, anti-angiogenic therapies, tumor-treating fields, or radiotherapy.
  • High-risk features as assessed by the Investigator, including brainstem or spinal cord involvement either as primary location or by significant tumor extension, clinically relevant functional or neurocognitive deficits due to the tumor (deficits resulting from surgery are allowed), or uncontrolled seizures (defined as persistent seizures interfering with ability to comply with protocol requirements).
  • 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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore placebo: Placebo
OFFERTA Placebo
Droga: Placebo
Placebo administered twice daily as a single agent dosed orally on Days 1 through 28 of a 28-day cycle. Participants may continue treatment with placebo until disease progression or another reason for discontinuation occurs.
Sperimentale: Safusidenib
Safusidenib 250 mg BID
Droga: Safusidenib
Safusidenib administered twice daily as a single agent dosed orally on Days 1 through 28 of a 28-day cycle. Participants may continue treatment until disease progression or another reason for discontinuation occurs.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Progression Free Survival (PFS) assessed by Blinded Independent Central Review (BICR) per modified Response Assessment in Neuro-Oncology (RANO) 2.0
Lasso di tempo: From the date of randomization until the date of first documented disease progression, approximately 30 months
PFS, defined as time from date of randomization to the date of the first occurrence of radiographic disease progression per modified RANO 2.0 assessed by BICR or death from any cause, whichever occurs earlier
From the date of randomization until the date of first documented disease progression, approximately 30 months

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Objective Response Rate (ORR) assessed by BICR per modified RANO 2.0
Lasso di tempo: From the date of randomization until the date of first documented disease progression, approximately 30 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
From the date of randomization until the date of first documented disease progression, approximately 30 months
Time to Next Intervention (TTNI)
Lasso di tempo: From the date of randomization until the date of the start of another anticancer treatment or date of death, approximately 30 months
TTNI, defined as the time from randomization to the initiation of first subsequent anticancer therapy or death from any cause, whichever occurs earlier.
From the date of randomization until the date of the start of another anticancer treatment or date of death, approximately 30 months
PFS assessed by the Investigator per modified RANO 2.0
Lasso di tempo: From the date of randomization until the date of first documented disease progression, approximately 30 months
PFS, defined as the time from date of randomization to the date of the first occurrence of radiographic disease progression per modified RANO 2.0 assessed by the Investigator or death from any cause, whichever occurs earlier
From the date of randomization until the date of first documented disease progression, approximately 30 months
ORR assessed by the Investigator per modified RANO 2.0
Lasso di tempo: From the date of randomization until the date of the first documented disease progression, approximately 30 months
ORR, defined as the proportion of participants with the confirmed best overall response of CR, PR, and MR per modified RANO 2.0 as assessed by the investigator.
From the date of randomization until the date of the first documented disease progression, approximately 30 months
Duration of Response (DOR) assessed by BICR and by the Investigator per modified RANO 2.0
Lasso di tempo: From the date of randomization until the date of first documented disease progression, approximately 30 months
DOR, the 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 or death from any cause, whichever occurs earlier, as assessed by BICR and by the Investigator.
From the date of randomization until the date of first documented disease progression, approximately 30 months
Time to Response (TTR) assessed by BICR and by the Investigator per modified RANO 2.0
Lasso di tempo: From randomization to the first documentation of objective response (CR, PR, or MR), approximately 30 months
TTR, defined as the time from randomization to the first documentation of objective response (CR, PR, or MR) per modified RANO 2.0 assessed by BICR and by the Investigator.
From randomization to the first documentation of objective response (CR, PR, or MR), approximately 30 months
Disease Control Rate (DCR) assessed by BICR and by the Investigator per modified RANO 2.0
Lasso di tempo: From the date of randomization until the date of first documented disease progression, approximately 30 months
DCR, defined as the proportion of participants with a best overall response of CR, PR, MR, or stable disease (SD) per modified RANO 2.0, as assessed by BICR and by the Investigator
From the date of randomization until the date of first documented disease progression, approximately 30 months
Tumor Growth Rate (TGR) by volume assessed by BICR
Lasso di tempo: From historical scans through the final scan in the study, approximately 30 months
TGR defined as the percentage change in tumor volume by unit of time, assessed by BICR
From historical scans through the final scan in the study, approximately 30 months
Overall Survival (OS)
Lasso di tempo: From the date of randomization until the date of death, approximately 30 months
OS, defined as the time from randomization to death from any cause
From the date of randomization until the date of death, approximately 30 months
Safety and tolerability
Lasso di tempo: From the first dose of study drug until 30 days after treatment discontinuation, approximately 30 months
The safety and tolerability of safusidenib compared with placebo 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
From the first dose of study drug until 30 days after treatment discontinuation, approximately 30 months
Safusidenib PK Profile
Lasso di tempo: From the first dose of study drug through approximately 16 weeks
Characterize the safusidenib concentrations
From the first dose of study drug through approximately 16 weeks
Health-Related Quality of Life
Lasso di tempo: From the first dose of study drug to treatment discontinuation, approximately 30 months
Evaluate health-related quality of life (HRQoL) with safusidenib compared with placebo assessed by the Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire scores.
From the first dose of study drug to treatment discontinuation, approximately 30 months
Health-Related Quality of Life
Lasso di tempo: From the first dose of study drug to treatment discontinuation, approximately 30 months
Evaluate health-related quality of life (HRQoL) with safusidenib compared with placebo assessed by the Quality of Life in Epilepsy (QOLIE-10-P) scores.
From the first dose of study drug to treatment discontinuation, approximately 30 months
Health-Related Quality of Life
Lasso di tempo: From the first dose of study drug to treatment discontinuation, approximately 30 months
Evaluate health-related quality of life (HRQoL) with safusidenib compared with placebo assessed by the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire scores.
From the first dose of study drug to treatment discontinuation, approximately 30 months
Seizure Activity
Lasso di tempo: From the date of randomization until the date of first documented disease progression, approximately 30 months
Evaluate seizure frequencies and severity including type of seizure, seizure-related AEs, and changes in anti-epileptic medications in participants receiving safusidenib compared with placebo
From the date of randomization until the date of first documented disease progression, approximately 30 months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Nuvation Bio Inc.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 marzo 2027

Completamento primario (Stimato)

1 maggio 2029

Completamento dello studio (Stimato)

1 marzo 2032

Date di iscrizione allo studio

Primo inviato

9 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

14 luglio 2026

Primo Inserito (Effettivo)

17 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

17 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

14 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • NUV-218-G307

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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