Phase 2: testing Safusidenib for Grade 2 IDH1-mutant Glioma
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 (confirmed by Blinded Independent Central Review \[BICR\] per modified Response Assessment in Neuro-Oncology \[RANO\] 2.0), and are not in need of immediate chemotherapy or radiotherapy.
Official registry: https://clinicaltrials.gov/study/NCT07703436 · Nuvation Bio Inc. · enrollment listed as 40
What this phase means
Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Safusidenib. The registry lists allocation as na. 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 (confirmed by Blinded Independent Central Review \[BICR\] per modified Response Assessment in Neuro-Oncology \[RANO\] 2.0), and are not in need of immediate chemotherapy or radiotherapy.
They plan to enroll about 40 people at 12 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
A Phase 2, Multicenter, Clinical Study to Evaluate the Efficacy and Safety of Safusidenib Erbumine in Participants With Isocitrate Dehydrogenase 1 (IDH1)-Mutant Glioma Who Discontinued Vorasidenib Treatment Due to Progressive Disease
Interventions: Safusidenib
Primary outcome (registry wording): Objective Response Rate (ORR) per modified Response Assessment in Neuro-Oncology (RANO) 2.0 assessed by Blinded Independent Central Review (BICR)
Who it is for (from inclusion criteria)
- Ages 18 Years to any
- Histologically confirmed Grade 2 or 3 IDH-mutant astrocytoma or IDH-mutant and 1p19q co-deleted oligodendroglioma, according to WHO CNS 2021 criteria
- IDH1 mutation (e.g., R132H/C/G/S/L) based on immunohistochemistry (IHC) (R132H only), PCR, or next generation sequencing (NGS)
- Have had at least 1 prior surgery for glioma (biopsy, sub-total resection, or gross total resection)
- Measurable disease per modified RANO 2.0 confirmed by BICR during Screening
- Previously treated with vorasidenib and experienced radiographic disease progression during treatment and are not in need of immediate chemotherapy or radiotherapy in the opinion of the Investigator. Disease progression must be confirmed by BICR using modified RANO 2.0
- Adequate hematologic and organ function
- Expected survival of ≥12 months
Who the registry excludes
- Any prior anticancer therapy other than surgery (biopsy, sub-total, or gross total resection) and vorasidenib for treatment of glioma
- Discontinued vorasidenib for toxicity or any reason other than radiographic disease progression
- Prior treatment with anti-angiogenic agents such as Avastin (bevacizumab) or investigational agents for glioma
- Brainstem or spinal cord involvement either as primary location, site of multifocal involvement, or by significant tumor extension
- Significant functional or neurocognitive deficits, including uncontrolled seizures
- 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
Public study contact (from the registry)
Clinical Trials at Nuvation Bio
ClinicalTrials@nuvationbio.com
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
12 listed- University of California, Los Angeles — Los Angeles, California (not_yet_recruiting)
- University of California, San Francisco — San Francisco, California (not_yet_recruiting)
- Yale University — New Haven, Connecticut (not_yet_recruiting)
- University of Miami Health — Miami, Florida (not_yet_recruiting)
- Indiana University — Indianapolis, Indiana (recruiting)
- LSU LCMC Health Cancer Center — New Orleans, Louisiana (not_yet_recruiting)
- Massachusetts General Hospital — Boston, Massachusetts (not_yet_recruiting)
- Rutgers Cancer Institute — New Brunswick, New Jersey (not_yet_recruiting)
- NYU Langone Health — New York, New York (recruiting)
- Columbia University Medical Center — New York, New York (not_yet_recruiting)
- Cleveland Clinic — Cleveland, Ohio (not_yet_recruiting)
- The Ohio State University Comprehensive Cancer Center — Columbus, Ohio (not_yet_recruiting)
FAQ about this NCT record
Is NCT07703436 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT07703436?
Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT07703436?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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