Duke logo

(MRZ-108) Triphase Marizomib for Malignant Glioma - Clinical Trial

What is the Purpose of this Study?

We are doing this study to find out if a drug called Marizomib (MRZ) has an effect (good or bad) in patients with brain cancer that has come back after initial treatment.

We also want to find out what is the most tolerable and safest dose that can be given when MRZ is given through a tube that goes through your nose to your stomach (known as a nasogastric or NG tube) when the standard dose of Bevacizumab (BEV) is also given to you.

What is the Condition Being Studied?

Brain Cancer (Grade IV Malignant Glioma)

Who Can Participate in the Study?

Adults who:
- Have been diagnosed with Grade IV Glioma (Glioblastoma or Gliosarcoma) that has come back or continued to grow after treatment with radiation therapy and chemotherapy (temozolomide)
- Have not had prior treatment with Bevacizumab (Avastin)

Age Group
Adults

What is Involved?

If you agree to be in this study, you will:
- Get treatment in 28 day cycles
-- Marizomib will be given to you through a tube through your nose into your stomach
-- Bevacizumab will be given to you through an IV
-- Additional cycles of the study drugs may be given to you depending on your response to the therapy
- Have other tests (physical exams, lab tests, and scans) to track your progress and record any side effects that you may have in reaction to the study drugs

Study Details

Full Title
A Phase I, Multicenter, Open-label, Dose-escalation Combination Study of Marizomib and Bevacizumab in Bevacizumab-Naïve Subjects with WHO Grade IV Malignant Glioma followed by Phase 2 Studies of Single Agent Marizomib and Combination Marizomib and Bevacizu
Principal Investigator
Neuro-oncologist
Protocol Number
IRB:PRO00059540
NCT:NCT02330562
Phase
Phase I
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
studyrecruitment@duke.edu
or
919-681-5698