RecruitingNeurological Cancer
ASTX727 in Recurrent/Progressive Non-enhancing IDH Mutant Gliomas
Eligible age
18+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
this research study is evaluating the highest dose of ASTX727 that can be administered safely to recurrent/progressive non-enhancing IDH mutant gliomas patients.
Sponsor: Massachusetts General Hospital
You may qualify if…
- ✓ Participants must be ≥18 years of age.
- ✓ Participants must have histologically or cytologically confirmed glioma, with documented IDH1 and/or IDH2 gene-mutation.
- ✓ Participants must have radiographic evidence of non-enhancing disease progression/recurrence per RANO criteria for low grade gliomas (LGG).
- ✓ Patients who have received prior treatment with chemotherapy, radiation, or a combination of both are eligible. Also, patients who have not received any prior treatment for their glioma are also eligible.
- ✓ Participants must be ≥12 weeks from completion of radiation.
- ✓ Participants must have a baseline brain MRI scan within 28 days prior to Day 1 of treatment.
- ✓ Participants must be on a stable or decreasing dose of glucocorticoids for 7 days prior to registration.
- ✓ Participants must have archived primary tumor biopsies or surgical specimens for additional exploratory translational studies. At least 100-micron length of FFPE tissue or a tissue block should be available for enrollment and for shipment to the Sponsor, or a laboratory designated by the Principal Investigator. If less material is available, participants could still be eligible after discussion with the Principal Investigator who will assess and confirm that there is sufficient material for key evaluations.
You may not qualify if…
- ✕ Participants with enhancing disease on brain MRI.
- ✕ 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.
- ✕ 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.
- ✕ Participants with prior treatment with bevacizumab (Avastin) are excluded.
- ✕ Participants who are pregnant or breast-feeding.
- ✕ Participants with an active severe infection that requires anti-infective therapy or with an unexplained fever \>38.5°C during screening visits or on their first day of study drug administration.
- ✕ Participants with known additional malignancy that is progressing or requires active treatment within 2 years of start of study drug. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, in situ cervical cancer that has undergone potentially curative therapy, or surgically treated prostate cancer.
- ✕ Participants with known hypersensitivity to any of the components of ASTX727.
Where it's recruiting
Massachusetts
Boston
Source: ClinicalTrials.gov · NCT03922555 · last updated 2026-04-16