OncoMatch/Clinical Trials/NCT03922555
ASTX727 in Recurrent/Progressive Non-enhancing IDH Mutant Gliomas
Is NCT03922555 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies ASTX727 for neurological cancer.
Treatment: ASTX727 — this research study is evaluating the highest dose of ASTX727 that can be administered safely to recurrent/progressive non-enhancing IDH mutant gliomas patients.
Check if I qualifyExtracted eligibility criteria
Biomarker criteria
Required: IDH1 mutation
Required: IDH2 mutation
Prior therapy
Cannot have received: bevacizumab (bevacizumab)
Participants with prior treatment with bevacizumab (Avastin) are excluded.
Cannot have received: systemic anticancer therapy
Exception: lomustine/CCNU must wait at least 42 days from last date of drug administration to registration
Participants who received systemic anticancer therapy <28 days prior to registration. One exception: participants on lomustine/CCNU must wait at least 42 days from last date of drug administration to registration.
Cannot have received: investigational agent
Participants who received an investigational agent <14 days prior to registration. In addition, the first dose of ASTX727 should not occur before a period ≥5 half-lives of the investigational agent has elapsed.
Lab requirements
Blood counts
Leukocytes ≥3,000/mcL; ANC ≥1500/mcL; Hemoglobin ≥10 g/dL; Platelets ≥100,000/mcL
Kidney function
Serum creatinine ≤2.0 x ULN OR creatinine clearance >40 mL/min (Cockroft-Gault)
Liver function
Serum total bilirubin ≤1.5 x ULN (unless Gilbert's disease); AST, ALT, ALP ≤3.0 x ULN
adequate bone marrow function as evidenced by: Leukocytes ≥ 3,000/mcL; Absolute neutrophil count ≥1500/mcL; Hemoglobin ≥10 g/dL; Platelets ≥100,000/mcL. adequate hepatic function as evidenced by: Serum total bilirubin ≤1.5 x ULN (unless considered due to Gilbert's disease); AST, ALT, ALP ≤3.0 x ULN. adequate renal function as evidenced by: Serum creatinine ≤2.0 x ULN OR Creatinine clearance >40 mL/min (Cockroft-Gault)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Massachusetts General Hospital Cancer Center · Boston, Massachusetts
- Brigham and Women's Hospital · Boston, Massachusetts
- Dana Farber Cancer Institute · Boston, Massachusetts
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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