Skip to main content

OKN-007-IV-RMG-201 A Phase II Open-Label Study Investigating the Efficacy, Safety and Pharmacokinetic Properties of OKN-007 Combined with Temozolomide in Patients with Recurrent Glioblastoma

NCT04388475

A Phase II Open-Label Study Investigating the Efficacy, Safety and Pharmacokinetic Properties of OKN-007 Combined with Temozolomide in Patients with Recurrent Glioblastoma

Associated Conditions

Brain Cancer

Principal Investigator

Sponsor

Oblato, Inc.

The main purpose of this study is to test the safety of an experimental drug called OKN‑007 when combined with an approved chemotherapy drug, temozolomide, in the treatment of brain cancer. Any effect it might have on your brain cancer will also be evaluated. OKN‑007 is an investigational product, which means it is a drug that has not yet been approved by the Food and Drug Administration (FDA), but is authorized by the FDA to be tested on patients. Temozolomide is considered a standard treatment option for recurrent glioblastoma, and all patients will receive temozolomide at the standard dose in combination with OKN-007 to investigate if this combination is safe. The dose of OKN-007 chosen for this study was established to be safe in previous clinical studies. We will also investigate what effects, if any, the drug may have on your tumor by measuring the size of your tumor during the course of the study treatment.

This study is currently enrolling.