Quisinostat + Radiotherapy for Glioblastoma

Overseen By Phase 0 Naviagtor

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Waitlist Available

Sponsor: Nader Sanai

No Placebo Group

Trial Summary

What is the purpose of this trial?

This is an open-label, multi-center Phase 0/1b study that will enroll up to 18 participants with recurrent WHO grade 4 glioblastoma (rGBM) IDH-wildtype (IDH-WT), Arm A, and 12 participants with presumed newly-diagnosed WHO grade 4 glioblastoma (nGBM) IDH-WT, Arm B. The trial will be composed of a Phase 0 component (subdivided into Arms A and B), and an Expansion Phase 1b. Patients with tumors demonstrating a positive pharmacokinetic (PK) response in the Phase 0 component of the study will graduate to an Expansion Phase that combines therapeutic dosing of quisinostat plus standard-of-care fractionated radiotherapy (RT).

Research Team

Nader Sanai, MD

Principal Investigator

Ivy Brain Tumor Center

Eligibility Criteria

This trial is for adults with newly-diagnosed or recurrent Grade 4 IDH-Wildtype Glioblastoma. Participants must have a specific type of brain tumor without certain genetic mutations (IDH-WT). The study has two parts: one for those with new diagnoses and another for those whose cancer has come back.

Inclusion Criteria

Confirmed negative serum pregnancy test before starting study treatment

For females of reproductive potential: use of highly effective contraception

I can swallow pills.

Exclusion Criteria

Treatment with another investigational drug or other intervention within 5 half-lives of the investigational product

Pregnancy or lactation

Known allergic reactions to components of the quisinostat

Treatment Details

Interventions

• Quisinostat (Histone Deacetylase Inhibitor)

Trial Overview The trial is testing Quisinostat, a drug, combined with standard radiotherapy. It's an early-phase study to see how the body processes the drug and if it's beneficial when added to radiation treatment in patients with this aggressive form of brain cancer.

Participant Groups

Group I: Recurrent WHO Grade 4 Glioblastoma IDH-WT Experimental Treatment 1 Intervention

Group II: Newly-Diagnosed WHO Grade 4 Glioblastoma IDH-WT Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Nader Sanai

Lead Sponsor

Trials

11

Recruited

440+