Study on the Safety and Effectiveness of Safusidenib for Patients with IDH1-Mutant Glioma After Stopping Vorasidenib Due to Disease Progression
Sponsor: Nuvation Bio Inc.
ClinicalTrials ID:NCT07703436
This clinical trial is testing a new treatment, Safusidenib, for patients with Grade 2 or 3 IDH1-mutant glioma who have previously been treated with Vorasidenib but experienced disease progression. The study aims to evaluate the safety and effectiveness of Safusidenib in these patients.
Patient Parameters
| Parameter | Options |
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Program Overview
The study involves up to 40 participants who have Grade 2 or 3 IDH1-mutant glioma, a type of brain tumor. These participants have had surgery and were treated with Vorasidenib, but their disease progressed. They are not in immediate need of chemotherapy or radiotherapy. The study will assess how safe and effective Safusidenib is for these patients.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with Grade 2 or 3 IDH-mutant astrocytoma or IDH-mutant and 1p19q co-deleted oligodendroglioma.
- Have an IDH1 mutation confirmed by specific tests.
- Have had at least one surgery for glioma.
- Have measurable disease confirmed by scans.
- Previously treated with Vorasidenib and experienced disease progression during treatment.
- Not in need of immediate chemotherapy or radiotherapy.
- Have good blood and organ function.
- Expected to live for at least 12 more months.
Exclusion Criteria
- Have received any cancer treatment other than surgery and Vorasidenib for glioma.
- Stopped taking Vorasidenib due to side effects or reasons other than disease progression.
- Have been treated with anti-angiogenic drugs like Avastin or other experimental drugs for glioma.
- Have tumors in the brainstem or spinal cord.
- Have significant functional or cognitive issues, including uncontrolled seizures.
- Have signs of leptomeningeal disease.
- Are using high doses of steroids for glioma symptoms. Low doses for other conditions are allowed.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of California, Los Angeles | 90095 | Los Angeles | California |
| University of California, San Francisco | 94143 | San Francisco | California |
| Yale University | 06510 | New Haven | Connecticut |
| University of Miami Health | 33136 | Miami | Florida |
| Indiana University | 46202 | Indianapolis | Indiana |
| LSU LCMC Health Cancer Center | 70112 | New Orleans | Louisiana |
| Massachusetts General Hospital | 02214 | Boston | Massachusetts |
| Rutgers Cancer Institute | 08901 | New Brunswick | New Jersey |
| NYU Langone Health | 10016 | New York | New York |
| Columbia University Medical Center | 10032 | New York | New York |
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