Safety and Efficacy Study in Recurrent or Progressive Grade III or IV IDH1 Mutated Glioma

Glioblastoma Multiforme Clinical Trial

Official title: An Open-Label, Phase 1/2A Dose Escalation Study of Safety and Efficacy of NEO100 in Recurrent or Progressive Grade III or Grade IV Gliomas With IDH1 Mutation

Status Recruiting

Clinical Trial Summary

This multi-site, Phase 1/2a clinical trial is an open label study to identify the safety, pharmacokinetics, and efficacy of a repeated dose regimen of NEO100 (perillyl alcohol) for the treatment of patients with radiographically-confirmed progression of Grade IV glioma or recurrent primary or secondary Grade IV glioma or patients with progressed or recurrent Grade III glioma. The study will have two phases, Phase 1 and Phase 2a. Phase 1 is a standard cohort dose escalation 3+3 design used to determine the maximum tolerated dose (MTD) for Phase 2a. Fifteen (15) patients were enrolled into the Phase I portion of the clinical trial. The MTD for NEO100 was not reached in humans. As a result the NEO100 dose for Cohort 4 (288 mg/dose - 1152 mg/day) was carried into the Phase 2a portion of the clinical trial. Four (4) patients were enrolled into this study prior to implementation of implementation of version 10 of the clinical trial restricting the Phase 2a population to patients with progressive or recurrent primary or secondary Grade IV gliomas expressing IDH1 mutations or progressive or recurrent primary or secondary Grade IV gliomas expressing IDH1 mutations. None of the four (4) patients expressed IDH1 mutations. There will be 28 patients with progressive or recurrent primary or secondary Grade IV gliomas expressing IDH1 mutations or progressive or recurrent primary or secondary Grade IV gliomas expressing IDH1 mutations enrolled in Phase 2a of the clinical trial. Prior to implementing v10 of this protocol, four (4) patients were enrolled. These patients met the inclusion/exclusion criteria for v9 of the protocol and had wild type IDH1 status. For both phases of the study, NEO100 will be self-administered four times daily for a 28-day treatment cycle up to six treatment cycles until disease progression or death, whichever occurs first. At the completion of cycle six, patients will be given the option to continue receiving compassionate use treatment cycles.

Clinical Trial Description

Perillyl alcohol has previously been tested in 15 clinical studies in > 600 subjects This includes 13 studies in 255 subjects using oral administration sponsored by the National Cancer Institute and two studies in > 350 subjects using intranasal administration in Brazil. NEO100 is a highly purified (>99%) form of perillyl alcohol. Studies in Brazil suggest improved survival for patients with recurrent glioblastoma. Doses of 96 mg qid, 144mg qid, 192mg qid, and 288 mg qid administered intranasally to patients with recurrent GBM for up to 6 months, disease progression or death. From 3 to 6 patients will be evaluated after first cycle (28 days) until MTD is reached. MRI with gadolinium will be at base line, and at the beginning of even cycles. A total of 25 patients will be treated at the MTD. PK studies will be conducted during Phase 1 at first dosing, and after first dose of 3rd cycle. ;

Related Conditions & MeSH terms

• Glioblastoma
• Glioblastoma Multiforme

• NCT number: NCT02704858
• Study type: Interventional
• Source: Neonc Technologies, Inc.
• Contact: Christopher Beardmore
• Phone: 224-218-2408
• Email: chris@anovaevidence.com
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: April 8, 2016
• Completion date: December 2024