OncoMatch/Clinical Trials/NCT03922555
ASTX727 in Recurrent/Progressive Non-enhancing IDH Mutant Gliomas
Is NCT03922555 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Other
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 →Frequently asked questions
Is NCT03922555 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior bevacizumab, systemic anticancer therapy, investigational agent disqualifies patients from enrollment.
Does this trial require IDH1?
Yes, IDH1 mutation is a required biomarker for enrollment.
Does this trial require IDH2?
Yes, IDH2 mutation is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify