ASTX727 in Recurrent/Progressive Non-enhancing IDH Mutant Gliomas
ConditionNeurological Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorMassachusetts General Hospital
About this trial
this research study is evaluating the highest dose of ASTX727 that can be administered safely to recurrent/progressive non-enhancing IDH mutant gliomas patients.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- ASTX727
Treatment groups
18 Participants
are divided into 2 treatment groupsSponsors and collaborators
Massachusetts General Hospital
Lead sponsor
Astex Pharmaceuticals, Inc.
Collaborator
Source ClinicalTrials.gov