New hope for asian brain tumor patients: targeted pill slows cancer growth
NCT ID NCT06780930
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests an experimental pill, vorasidenib, in Asian patients with a slow-growing but serious brain tumor (grade 2 glioma) that has a specific genetic mutation (IDH1 or IDH2). About 57 participants will receive either the drug or a placebo to see if it delays tumor progression. The goal is to offer a less toxic alternative to chemotherapy or radiation.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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57 people
The number who actually took part.
- Started
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Oct 2024
- Expected to finish
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Oct 2030
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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12 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Be at least 12 years of age (for Randomized Double-Blind phase) and weigh at least 40 kg. * Have a Karnofsky Performance Scale (KPS) score (for participants ≥16 years of age) or Lansky Play Performance Scale (LPPS) score (for participants \<16 years of age) of ≥80%. * Have Grade 2 oligodendroglioma or astrocytoma per WHO 2016 criteria. * Have had at least 1 prior surgery for glioma with the most recent one having occurred at least 1 year (-1 month) and not more than 5 years (+3 months) before randomization, and no other prior anticancer therapy, including radiotherapy and not be in need of immediate chemotherapy or radiotherapy. * Have confirmed IDH1 (IDH1 R132H/C/G/S/L mutation variants tested) or IDH2 (IDH2 R172K/M/W/S/G mutation variants tested) gene mutation status disease * Have MRI-evaluable, measurable, non-enhancing disease, as confirmed by the BIRC for double blind part. Exclusion Criteria: * Have had any prior anticancer therapy other than surgery (biopsy, sub-total resection, gross-total resection) for treatment of glioma including systemic chemotherapy, radiotherapy, vaccines, small-molecules, IDH inhibitors, investigational agents, laser ablation, etc. * Concurrent active malignancy except for a) curatively resected nonmelanoma skin cancer or b) curatively treated carcinoma in situ. Participants with previously treated malignancies are eligible provided they have been disease-free for 3 years at Screening. * Have any other acute or chronic medical or psychiatric condition that may increase the risk associated with the study participation or investigational product administration or may interfere with the interpretation of study results. * Have known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, known positive human immunodeficiency virus antibody results, or AIDS-related illness. Participants with a sustained viral response to HCV treatment or immunity to prior HBV infection will be permitted. Participants with chronic HBV that is adequately suppressed by institutional practice will be permitted.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Chang Gung Memorial Hospital,
Taoyuan, Taiwan
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Huashan Hospital Fudan University
Shanghai, 200040, China
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Sanbo Brain Hospital, Capital Medical University
Beijing, China
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Taipei Veterans General Hospital
Taipei, Taiwan
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The Second Affiliated Hospital of Air Force Military Medical University
Xi'an, China
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The Second People's Hospital of Shenzhen
Shenzhen, Guangdong, China
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Tiantan Hospital
Beijing, 100070, China
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West China Hospital Sichuan University
Chengdu, Sichuan, China