Clinical trials: IDH-mutant Gliomas
Glioblastoma, IDH-wildtype, Glioblastoma
Evaluation of Eflornithine Plus Temozolomide in Patients With Newly Diagnosed Glioblastoma or Astrocytoma
The purpose of this study is to establish the recommended phase 2 dose of eflornithine in combination with temozolomide in patients whose glioblastoma or astrocytoma is newly diagnosed, and to evaluate safety and tolerability of…
- Conditions
- Glioblastoma, IDH-wildtype, Glioblastoma, Glioblastoma Multiforme, Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype
- Trial name
- NCT05879367
- Testing
- Eflornithine (Dose Level 1), Eflornithine (Dose Level 2), Eflornithine (Dose Level -1)
- Where
- 8 sites in United States
- Volunteers
- 66 people
- Sponsor
- Orbus Therapeutics, Inc.
Glioma
Vorasidenib in CNS WHO Grade 2 IDH-mutant Diffuse Glioma
The goal of this prospective, observational study VIOLETA is to collect real-world data on vorasidenib treatment in a broad patient population.
- Trial name
- VIOLETA (NCT07240662)
- Testing
- Vorasidenib
- Where
- Germany
- Volunteers
- 150 people
- Sponsor
- iOMEDICO AG
Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype, Astrocytoma, Grade III
A Study of Zedoresertib (Debio 0123) in Combination With Temozolomide in Adult Participants With Recurrent or Progressive Glioblastoma and of Zedoresertib (Debio 0123) in Combination With Temozolomide and Radiotherapy in Adult Participants With Newly Diagnosed Glioblastoma
The primary purpose of the Phase 1 (Dose Escalation) of this study is to identify the dose-limiting toxicities (DLTs) of zedoresertib combined with temozolomide (TMZ) (Arm A) and with TMZ and radiotherapy (RT) (Arms B and C) and…
- Trial name
- NCT05765812
- Testing
- Zedoresertib, Temozolomide, Radiotherapy
- Where
- 16 sites in United States, Spain and 1 more
- Volunteers
- 116 people
- Sponsor
- Debiopharm International SA
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.
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.
Glioblastoma
A Study of PLB1001 Enteric Capsules in the Treatment of sGBM/IDH Mutant Glioblastoma Patients With the ZM Fusion Gene (FUGEN).
The goal of this clinical trial is to evaluate the safety and efficacy of PLB1001 Enteric Capsules in the treatment of PTPRZ1-MET fusion gene positive recurrent secondary glioblastoma. The main questions it aims to answer are: 1.
- Trial name
- NCT06105619
- Testing
- PLB1001, Temozolomide, Cisplatin combined with Etoposide
- Where
- China
- Volunteers
- 84 people
- Sponsor
- Beijing Pearl Biotechnology Limited Liability Company
Glioma
A Study to Evaluate the Safety and Efficacy of L19TNF With Alkylating Chemotherapy for Patients With Recurrent IDH-mutant Astrocytoma or Oligodendroglioma
The purpose of this study is to explore the safety and efficacy of the antibody-cytokine fusion protein L19TNF alone or in combination with alkylating chemotherapy in patients with recurrent IDH mutant glioma.
- Trial name
- IMAGLIO (NCT07120984)
- Testing
- L19TNF, L19TNF and TMZ, L19TNF and CCNU
- Volunteers
- 52 people
- Sponsor
- Philogen S.p.A.
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.
Glioblastoma, Adult-type Diffuse Gliomas
Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Previously Treated Glioblastoma or Other Primary Central Nervous System Tumors Harboring Activating FGFR1-3 Alterations
This is an open-label, monotherapy study of pemigatinib in participants with recurrent glioblastoma (GBM) or other recurrent gliomas, circumscribed astrocytic gliomas, and glioneuronal and neuronal tumors with an activating…
- Trial name
- FIGHT-209 (NCT05267106)
- Testing
- Pemigatinib
- Where
- 79 sites in United States, Denmark and 7 more
- Volunteers
- 83 people
- Sponsor
- Incyte Corporation
Pediatric Tumor of CNS, Pediatric Tumor of Brain
A Study of the Safety, Dosing, and Delivery of NEO100 in Patients With Pediatric Brain Tumors
This is an open label, Phase 1b safety, dose-finding, brain tumor delivery, and pharmacokinetics study of intranasal NEO100 in patients with pediatric-type diffuse high grade gliomas.
- Conditions
- Pediatric Tumor of CNS, Pediatric Tumor of Brain, Diffuse Midline Glioma, H3 K27M-Mutant, Pediatric Tumor of Brain Stem
- Trial name
- NCT06357377
- Testing
- NEO100
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Neonc Technologies, Inc.
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
Diffuse Astrocytoma, IDH-Mutant, Glioblastoma, IDH-wildtype
Safety and Efficacy of NEO212 in Patients With Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype or Brain Metastasis
This multi-site, Phase 1/2 clinical trial is an open-label study to identify the safety, pharmacokinetics, and efficacy of a repeated dose regimen of NEO212 alone for the treatment of patients with radiographically-confirmed…
- Conditions
- Diffuse Astrocytoma, IDH-Mutant, Glioblastoma, IDH-wildtype, Brain Metastases, Adult, Cervical Cancer
- Trial name
- NCT06047379
- Testing
- NEO212 Oral Capsule, Ipilimumab, Pembrolizumab
- Where
- 8 sites in United States
- Volunteers
- 134 people
- Sponsor
- Neonc Technologies, Inc.
Gastrointestinal Stromal Tumors, GIST
A Drug-drug Interaction Study of Avapritinib and Midazolam
The purpose of this study is to investigate the effect of multiple dosing of avapritinib on the pharmacokinetics (PK) of midazolam in adult patients with metastatic or unresectable gastrointestinal stromal tumors (GIST)…
- Conditions
- Gastrointestinal Stromal Tumors, GIST, Non-resectable Advanced Solid Tumors, Recurrent or Unresectable Central Nervous System (CNS) Tumors
- Trial name
- NCT04908176
- Testing
- Avapritinib, midazolam
- Where
- 3 sites in United States
- Volunteers
- 10 people
- Sponsor
- Blueprint Medicines Corporation