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

14 lipca 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Szacowany)

140

Faza

  • Faza 3

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Poczwórny

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Komparator placebo: Placebo
BID placebo
Lek: 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.
Eksperymentalny: Safusidenib
Safusidenib 250 mg BID
Lek: 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Progression Free Survival (PFS) assessed by Blinded Independent Central Review (BICR) per modified Response Assessment in Neuro-Oncology (RANO) 2.0
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Objective Response Rate (ORR) assessed by BICR per modified RANO 2.0
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Nuvation Bio Inc.

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 marca 2027

Zakończenie podstawowe (Szacowany)

1 maja 2029

Ukończenie studiów (Szacowany)

1 marca 2032

Daty rejestracji na studia

Pierwszy przesłany

9 lipca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

14 lipca 2026

Pierwszy wysłany (Rzeczywisty)

17 lipca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

17 lipca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

14 lipca 2026

Ostatnia weryfikacja

1 lipca 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • NUV-218-G307

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Tak

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

produkt wyprodukowany i wyeksportowany z USA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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Badania kliniczne na Safusidenib

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