Clinical trials: IDH1-mutant Glioma
WHO Grade II Glioma
A Study of DS-1001b in Patients With Chemotherapy- and Radiotherapy-Naive IDH1 Mutated WHO Grade II Glioma
This Phase 2 study is conducted to assess the efficacy and safety of DS-1001b in patients with chemotherapy- and radiotherapy-naive IDH1 mutated WHO grade II glioma.
- Trial name
- NCT04458272
- Testing
- DS-1001b
- Where
- 11 sites in Japan
- Volunteers
- 25 people
- Sponsor
- Daiichi Sankyo Co., Ltd.
Residual or Recurrent Grade 2 IDH Mutant Glioma
Phase 3 Study of Vorasidenib (S095032/AG-881) in Asian Participants With Residual or Recurrent Grade 2 Glioma With an IDH1 orIDH2 Mutation
The objective of this study is to determine the efficacy, safety, and pharmacokinetics of vorasidenib in Asian participants with residual or recurrent Grade 2 glioma with an IDH1 or IDH2 mutation.
- Trial name
- NCT06780930
- Testing
- Vorasidenib
- Where
- 8 sites in China, Taiwan
- Volunteers
- 57 people
- Sponsor
- Servier
Epilepsy; Seizure
ES-481 for Uncontrolled Glioma-Associated Epilepsy and Assessment for Potential Anti-Tumorigenic Effect in Patients With Isocitrate Dehydrogenase 1 (IDH1) Mutant Tumors
Phase 2A single-arm exploratory clinical study in up to 12 adult subjects aged 18 and older with primary glioma, IDH1 mutation, and uncontrolled focal-onset seizure activity to determine the potential efficacy, safety and…
- Trial name
- NCT04737174
- Testing
- ES-481
- Sponsor
- ES Therapeutics Australia Pty Ltd
Grade 2 IDH1-mutant Glioma, Grade 3 IDH1-mutant Glioma
Safety and Efficacy Study of Safusidenib in Participants With IDH1-Mutant Glioma Who Discontinued Vorasidenib Treatment Due to Progressive Disease
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…
- Conditions
- Grade 2 IDH1-mutant Glioma, Grade 3 IDH1-mutant Glioma, Glioma, IDH1-mutant Glioma
- Trial name
- NCT07703436
- Testing
- Safusidenib
- Where
- 12 sites in United States
- Volunteers
- 40 people
- Sponsor
- Nuvation Bio Inc.
Glioma, Astrocytoma, Grade IV
SIGMA (Safusidenib in IDH1 Mutant Glioma Maintenance)
This is a 3-part study. The purpose of Part 1 of the study is to evaluate the efficacy, safety, and pharmacokinetic (PK) characteristics of safusidenib in participants with recurrent/progressive IDH1-mutant World Health…
- Conditions
- Glioma, Astrocytoma, Grade IV, IDH1-mutant Glioma, Astrocytoma, IDH-Mutant, Grade 3
- Trial name
- SIGMA (NCT05303519)
- Testing
- safusidenib
- Where
- 61 sites in United States, Australia and 1 more
- Volunteers
- 365 people
- Sponsor
- Nuvation Bio Inc.
Gliomas
A Multicentre, Retrospective-prospective Real-world Study: to Evaluate the Effectiveness and Safety of Vorasidenib in Patients With Isocitrate Dehydrogenase IDH1/2 Mutant Grade 2 Astrocytoma or Oligodendroglioma (VICTORIA Study)
The goal of this Study is to evaluate the effectiveness and safety of Vorasidenib in Patients with Isocitrate dehydrogenase IDH1/2 mutant Grade 2 astrocytoma or oligodendroglioma, primary purposeis to evaluate the efficectiveness…
- Trial name
- VICTORIA (NCT06969352)
- Testing
- Vorasidenib
- Where
- 3 sites in China
- Volunteers
- 62 people
- Sponsor
- Servier (Tianjin) Pharmaceutical Co. LTD.
Grade 2 Glioma (Astrocytoma or Oligodendroglioma) With an IDH1 Mutation, Astrocytoma IDH Mutant Grade 2
Safety and Efficacy Study of Safusidenib in Participants With Grade 2 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…
- Conditions
- Grade 2 Glioma (Astrocytoma or Oligodendroglioma) With an IDH1 Mutation, Astrocytoma IDH Mutant Grade 2, Oligodendroglioma, Oligodendroglioma IDH-mutant and 1p/19q-codeleted
- Trial name
- NCT07712757
- Testing
- Safusidenib
- Volunteers
- 140 people
- Sponsor
- Nuvation Bio Inc.
High Grade Glioma, Astrocytoma
Study of Olutasidenib and Temozolomide in HGG
The goal of this study is to determine the efficacy of the study drug olutasidenib to treat newly diagnosed pediatric and young adult patients with a high-grade glioma (HGG) harboring an IDH1 mutation.
- Conditions
- High Grade Glioma, Astrocytoma, Astrocytoma, Grade III, Astrocytoma, Grade IV
- Trial name
- NCT06161974
- Testing
- Olutasidenib + TMZ
- Where
- 20 sites in United States, Australia and 5 more
- Volunteers
- 60 people
- Sponsor
- Rigel Pharmaceuticals