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NCT02704858 · ClinicalTrials.gov registry record · Phase 1
Safety and Efficacy Study in Recurrent or Progressive Grade III or IV IDH1 Mutated Glioma
A Phase 1 study of Glioblastoma Multiforme, sponsored by Neonc Technologies.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 49
- Enrollment target
- 12
- Study locations
NCT02704858 is a Phase 1 study of Glioblastoma Multiforme that is actively recruiting participants, run by Neonc Technologies. The registered enrollment target is 49 participants, below the 96-participant average among 88 other Glioblastoma Multiforme trials with a reported enrollment target (49% lower). The trial reports 12 study locations across 10 states.
The verdict
NCT02704858, a Phase 1 study of Glioblastoma Multiforme, is actively recruiting participants, sponsored by Neonc Technologies.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 49 participants
- Enrollment target
- 12
- Study locations
Study 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. 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 for Phase 2a. There will be up to 24 patients enrolled in Phase 1. There will be 25 patients enrolled in Phase 2a. For both phases of the study, NEO100 will be self-administered four times daily for a 28-day treatment cycles until disease progression, death or patient withdraw from study for any reason, whichever occurs first. Version 10 of the protocol changed the inclusion criteria for Phase 2a to limit inclusion to those patients with progressive or recurrent primary or secondary Grade IV gliomas expressing IDH1 mutations. Prior to the protocol amendment, 4 patients were enrolled who were IDH1 wild-type. Therefore, an additional 28 patients will be recruited for a total of 32 patients enrolled into Phase 2a of this study to have 35 evaluable cases. Version 12 of the protocol expanded the inclusion criteria for Phase 2a to include those patients with progressive or recurrent Grade III Astrocytoma expressing IDH1 mutations. Review of the literature specific to these patients found the same expected time to progression and death. As a result, the number of patients to enroll remains 32 to have 35 evaluable cases.
Conditions Studied
Interventions
- DRUG Perillyl alcohol
Study Locations (12)
California
- University of Southern California - Los Angeles
- Saint John Cancer Institute - Santa Monica
Texas
- Baylor Scott & White Health - Dallas
- University of Texas Southwestern Medical Center - Dallas
Georgia
- Georgia Cancer Center (Augusta University) - Augusta
Louisiana
- Ochsner Health - New Orleans
New Jersey
- Atlantic Health (Overlook Medical Center) - Summit
New York
- Northwell Health - New York
North Carolina
- Wake Forest University Health Sciences - Winston-Salem
Ohio
- Cleveland Clinic - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2017-08-01 |
| Est. Completion | 2026-06 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02704858
The ClinicalTrials.gov registry entry for NCT02704858 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 49 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 96-participant average among 88 other Glioblastoma Multiforme trials with a reported enrollment target (49% lower). The listed sponsor is Neonc Technologies, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Glioblastoma Multiforme appearing as the primary indexed condition, and to 1 intervention - of which Perillyl alcohol is the first listed.
NCT02704858 reports 12 study locations spanning 10 distinct geographic areas - top geographies include California, Texas, Georgia.
Frequently Asked Questions
What is clinical trial NCT02704858 about?
NCT02704858 is a clinical study titled "Safety and Efficacy Study in Recurrent or Progressive Grade III or IV IDH1 Mutated Glioma". 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 second...
What is the current status of trial NCT02704858?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 49 participants. The study started on 2017-08-01. Estimated completion is 2026-06.
What conditions does trial NCT02704858 study?
This clinical trial studies the following conditions: Glioblastoma Multiforme.
What interventions are being tested in trial NCT02704858?
The interventions under investigation include: Perillyl alcohol (DRUG).
Who is sponsoring clinical trial NCT02704858?
This trial is sponsored by Neonc Technologies, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02704858 being conducted?
This trial has 12 study locations across California, Georgia, Louisiana, New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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