Trial · NCT06357377
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Nature and severity of adverse events | 6 months | Assess the safety and tolerability of increasing dose levels of intranasally administered NEO100 using the NCI CTCAE (version 5.0) for reporting of non-hematologic AEs |
| Secondary | Identify the maximum tolerated dose (MTD) of NEO100 | 6 months | Assess the maximum tolerated dose (MTD) of intranasally administered NEO100 using the NCI CTCAE (version 5.0) for reporting of non-hematologic AEs |
| Secondary | Determine the recommended Phase 2 dose (RP2D) of NEO100 | 6 months | Assess the maximum tolerated dose (MTD) of intranasally administered NEO100 using the NCI CTCAE (version 5.0) for reporting of non-hematologic AEs |
| Secondary | Measurement of NEO100 and its metabolite perillic acid in brain tumor tissue | 6 months | Confirm brain tumor delivery by measuring levels of NEO100 (POH) and its metabolite perillic acid (PA) in postsurgical tumor tissue in patients with pediatric-type brain tumors (measured in ng/mg). |
| Secondary | Blood brain barrier penetration | 6 months | To confirm blood brain barrier (BBB) penetration of NEO100 by measuring the concentration of NEO100 and its metabolite in resected tumor tissue. |
| Secondary | Characterize the pharmacokinetics (PK) of NEO100 as measured by Peak Plasma Concentration | 6 months | Pharmacokinetic parameters of NEO100 metabolite perillic acid in the resected tumor tissue as measured by peak plasma concentration (Cmax). |
| Secondary | Characterize the pharmacokinetics (PK) of NEO100 as measured by the Time to Peak Plasma Concentration | 6 months | Pharmacokinetic parameters of NEO100 metabolite perillic acid in the resected tumor tissue as measured by the time to peak plasma concentration (Tmax). |
| Secondary | Characterize the pharmacokinetics (PK) of NEO100 as measured by Area Under the Curve | 6 months | Pharmacokinetic parameters of NEO100 metabolite perillic acid in the resected tumor tissue as measured by the area under the plasma concentration vs time curve (AUC). |
| Secondary | To assess efficacy of NEO100 based on objective response rate (ORR). | 6 months | Objective CNS tumor response to NEO100 as determined by RANO 2.0 criteria. |
| Secondary | To assess efficacy of NEO100 based on progression free survival (PFS). | 6 months | Progression free survival (PFS). |
| Secondary | To assess efficacy of NEO100 based on overall survival (OS). | 6 months | Overall survival (OS). |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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GET https://conductscience.org/api/trials/v1/NCT06357377/registered