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

2026년 7월 14일 업데이트: 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.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

140

단계

  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 네 배로

무기와 개입

참가자 그룹 / 팔
개입 / 치료
위약 비교기: 위약
위약 BID
의약품: 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.
실험적: Safusidenib
Safusidenib 250 mg BID
의약품: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Progression Free Survival (PFS) assessed by Blinded Independent Central Review (BICR) per modified Response Assessment in Neuro-Oncology (RANO) 2.0
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Objective Response Rate (ORR) assessed by BICR per modified RANO 2.0
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Nuvation Bio Inc.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2027년 3월 1일

기본 완료 (추정된)

2029년 5월 1일

연구 완료 (추정된)

2032년 3월 1일

연구 등록 날짜

최초 제출

2026년 7월 9일

QC 기준을 충족하는 최초 제출

2026년 7월 14일

처음 게시됨 (실제)

2026년 7월 17일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 7월 17일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 7월 14일

마지막으로 확인됨

2026년 7월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • NUV-218-G307

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

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미국 FDA 규제 의약품 연구

예

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아니

미국에서 제조되어 미국에서 수출되는 제품

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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