Study of 2-hydroxyoleic Acid in Pediatric Patients With Malignant Glioma and Other Advanced Solid Tumors
Status:
Recruiting
Trial end date:
2022-03-01
Target enrollment:
Participant gender:
Summary
An open label, non-randomized study in pediatric patients with advanced high-grade gliomas
and other solid tumors.
The study will be performed in two phases: a dose escalation phase in up to 18 patients
following a standard "3+3" design to establish dose-limiting toxicity (DLT) and a "safe" dose
of 2-OHOA followed by an expanded safety cohort of up to 10 patients treated at the Maximum
Tolerated Dose (MTD). If the MTD is well tolerated in the expanded safety cohort, that dose
becomes the Recommended Phase 2 Dose (RP2D).
Glioma patients and other solid tumor patients (including non-glial brain tumors) will be
treated as a single cohort. Patients with either tumor type will be allowed to enroll on the
study as positions are made available. No tumor type will be given priority over another and
there is no minimum number of glioma patients or solid tumor patients that must be enrolled
on the trial.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Laminar Pharmaceuticals
Collaborators:
Dana-Farber Cancer Institute Hackensack Meridian Health Laminar Pharma Inc