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Safety and Efficacy Study in Recurrent or Progressive Grade III or IV IDH1 Mutated Glioma
NCT02704858 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 49 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Neonc Technologies, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02704858 reports 12 study locations spanning 10 distinct geographic areas — top geographies include California, Texas, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02704858?
The interventions under investigation include: Perillyl alcohol (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02704858?
This trial is sponsored by Neonc Technologies, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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