A perioperative study of Safusidenib in patients with IDH1 -mutated glioma.
Cain Craig Truman ClarkMonique ToppMark RosenthalRobert ToblerSaskia FreytagSarah A BestJames R WhittleKatharine J DrummondPublished in: Future oncology (London, England) (2024)
This is a single arm, open label perioperative trial to assess the feasibility, pharmacokinetics and pharmacodynamics of treatment with safusidenib following biopsy, and prior to surgical resection in patients with IDH1 mutated glioma who have not received radiation therapy or chemotherapy. Fifteen participants will receive treatment in two parts. First, biopsy followed by one cycle (28 days) of safusidenib, an orally available, small molecular inhibitor of mutated IDH1, then maximal safe resection of the tumor (Part A). Second, after recovery from surgery, safusidenib until disease progression or unacceptable toxicity (Part B). This research will enable objective measurement of biological activity of safusidenib in patients with IDH1 mutated glioma. Anti-tumor activity will be assessed by progression free survival and time to next intervention. Clinical Trial Registration: NCT05577416 (ClinicalTrials.gov).
Keyphrases
- wild type
- clinical trial
- open label
- low grade
- radiation therapy
- free survival
- phase ii
- study protocol
- randomized controlled trial
- patients undergoing
- cardiac surgery
- minimally invasive
- ultrasound guided
- oxidative stress
- locally advanced
- phase ii study
- fine needle aspiration
- coronary artery bypass
- acute kidney injury
- double blind
- replacement therapy
- rectal cancer