A Phase IB Study to Assess Safety of Concurrent Azeliragon With Craniospinal Irradiation in Patients With Leptomeningeal Metastasis From Solid Tumor Malignancies or High-Grade Gliomas

Summary

Single institution study to assess the safety of concurrent Azeliragon with craniospinal irradiation (CSI) in patients with leptomeningeal metastasis from solid tumor malignancies and high-grade gliomas.

Eligibility

Age range

18+ years

Sex

All

Healthy volunteers

No

Interventions

• Drug
  Azeliragon

  Azeliragon is orally administered. Patients start Azeliragon 7 days before CSI and take their last dose 7 days post-CSI. The first 6 patients will start at Dose Level 1 \[DL1\] (Loading dose for 7 days: 30 mg twice daily; Concurrent/adjuvant dose: 20 mg once daily). If 1 or fewer of 6 patients develop dose-limiting toxicity (DLT) then the recommended dose will be DL1. If at least 2 of 6 develops a DLT, then an additional 6 patients will be enrolled at Dose Level -1 \[DL-1\] (Loading dose for 7 days: 15mg twice daily; Concurrent/adjuvant dose: 10mg once daily). If 1 or fewer out of 6 patients at DL-1 develop DLT, then the recommended dose will be DL-1. If at least 2 of 6 at DL-1 develops a DLT, then an additional 6 patients will be enrolled at Dose Level -2 \[DL-2\] (Loading dose for 7 days: 15mg twice daily; Concurrent/adjuvant dose: 5mg once daily). At the recommended dose, an additional 14 patients will be enrolled for the Dose Expansion portion.

• Procedure
  CSI

  Patients will receive CSI.

Location