Actively Recruiting
ASTX727 in Recurrent/Progressive Non-enhancing IDH Mutant Gliomas
Led by Massachusetts General Hospital · Updated on 2026-04-16
18
Participants Needed
3
Research Sites
472 weeks
Total Duration
On this page
Sponsors
M
Massachusetts General Hospital
Lead Sponsor
A
Astex Pharmaceuticals, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
this research study is evaluating the highest dose of ASTX727 that can be administered safely to recurrent/progressive non-enhancing IDH mutant gliomas patients.
CONDITIONS
Official Title
ASTX727 in Recurrent/Progressive Non-enhancing IDH Mutant Gliomas
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be 18 years of age or older.
- Participants must have confirmed glioma with documented IDH1 and/or IDH2 gene mutation.
- Radiographic evidence of non-enhancing disease progression or recurrence by RANO criteria for low grade gliomas.
- Participants may have had prior chemotherapy, radiation, or no prior treatment.
- Participants must be at least 12 weeks from completion of radiation therapy.
- Baseline brain MRI within 28 days before starting treatment.
- Stable or decreasing glucocorticoid dose for at least 7 days before registration.
- Archived tumor tissue available for translational studies, with sufficient material.
- Ability to understand and sign informed consent (or via authorized representative).
- Karnofsky Performance Status (KPS) of 70 or higher.
- Expected survival of at least 6 months.
- Adequate bone marrow function (leukocytes ≥3000/mcL, neutrophils ≥1500/mcL, hemoglobin ≥10 g/dL, platelets ≥100,000/mcL).
- Adequate liver function (bilirubin ≤1.5x ULN unless Gilbert's disease, AST/ALT/ALP ≤3x ULN).
- Adequate kidney function (creatinine ≤2.0x ULN or creatinine clearance >40 mL/min).
- Recovery from prior surgery, radiotherapy, or cancer therapy toxic effects (Grade 1 toxicity allowed).
- Female participants of reproductive potential must have a negative pregnancy test within 14 days before treatment and agree to use effective contraception during and 90 days after treatment. Male participants with partners of reproductive potential must also agree to contraception.
- Participants in the expansion cohort must meet all above criteria and have surgically accessible tumors and be surgical candidates.
You will not qualify if you...
- Participants with enhancing disease visible on brain MRI.
- Receipt of systemic anticancer therapy less than 28 days before registration (except lomustine/CCNU with at least 42 days).
- Receipt of investigational agents less than 14 days before registration or within 5 half-lives before ASTX727 dosing.
- Prior treatment with bevacizumab (Avastin).
- Pregnant or breastfeeding participants.
- Active severe infection requiring treatment or unexplained fever over 38.5°C during screening or first day of study drug.
- Known progressing malignancy requiring active treatment within 2 years, except certain skin and cervical cancers and treated prostate cancer.
- Known allergy to components of ASTX727.
- History of myocardial infarction within 6 months before screening.
- Known severe or uncontrolled ventricular arrhythmias.
- QTc interval ≥450 msec or other significant risk factors for QT prolongation.
- Known HIV infection or active hepatitis B or C.
- Any medical or psychological condition likely to interfere with consent, cooperation, or participation.
- Known swallowing or absorption problems limiting oral drug intake.
- Evidence of intracranial or intratumoral hemorrhage, except resolving post-surgical changes or small hemorrhages.
- Expansion cohort participants deemed unsuitable for surgery by their physician or surgeon.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114
Actively Recruiting
2
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
3
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Actively Recruiting
Research Team
I
Isabel Arrillaga-Romany, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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