NCT02704858 · Neonc Technologies, Inc.
Safety and Efficacy Study in Recurrent or Progressive Grade III or IV IDH1 Mutated Glioma
What this study is about
This multi-site, Phase 1/2a clinical trial is an where both patients and doctors know the treatment given study to identify the safety, how the drug moves through the body, and effectiveness 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.
View original scientific description
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.
Interventions
DRUG
Perillyl alcohol
Intranasal administration
Primary outcome measures
Phase 1 Primary Outcome: Number of Participants with Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
Time frame: Up to 6 months
Phase 2 Primary Outcome: Number of Participants Who Are Alive Each Month For 6 Months
Time frame: Up to 6 months
Phase 2 Primary Outcome: Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related To Treatment
Time frame: 6 months
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- • To be eligible to participate in the study, a patient must meet all of the following inclusion criteria: Patient must:
- Have radiographically-confirmed progression of, or recurrent, primary or
- secondary Grade IV glioma, including infratentorial (brainstem, cerebellar) glioma (confirmed by biopsy) and subcortical glioma.
- Have radiographically-confirmed progression of, recurrent, primary or secondary Grade III astrocytoma.
- All patients must be on a stable or decreasing dose of steroids for at least five days prior to the date of informed consent. Patient must have failed previous radiation treatment or combined treatment with temozolomide and radiation. If progression of disease occurs within 90 days of conformal radiation, the progression/recurrence must be outside of the radiation field or proven by biopsy/resection. Patient must be ≥ 18 years of age. Patient must have an ECOG performance status of 0-2 or KPS ≥ 60 (the latter for Phase 1 only). Pati
Where
- Los Angeles, California
- San Francisco, California
- Santa Monica, California
- Augusta, Georgia
- New Orleans, Louisiana
- Summit, New Jersey
- New York, New York
- Winston-Salem, North Carolina
- Cleveland, Ohio
- Dallas, Texas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 2, 2026 · Source of record for eligibility and locations