Trial · NCT05698524
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 | Toxicities Associated with PCI-24781/Abexinostat and Metronomic Temozolomide Therapy - Adverse Events and Serious Adverse Events | Up to 25 months | The incidence of adverse events (AEs) and serious adverse events (SAEs) will be recorded for each dose level cohort. Toxicities will be assessed using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Toxicities will be graded on from 1 to 5, with higher numbers indicating a higher severity grade. |
| Primary | Toxicities Associated With PCI-24781/Abexinostat and Metronomic Temozolomide Therapy - Overall | Up to 25 months | The frequency of overall toxicity occurrence will be categorized by toxicity grades using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Toxicities will be graded ranging from 1 to 5, with higher numbers indicating a higher severity grade. |
| Primary | Recommended Dose Determination of PCI-24781/Abexinostat | Up to 20 months | Participants who either complete the first cycle of treatment or experience a dose-limiting toxicity (DLT) within the first cycle of treatment will be considered evaluable. The target DLT rate for the maximum tolerated dose (MTD) is 0.25. The MTD determination will be based on isotonic regression. The MTD will be defined as the dose for which the isotonic estimate of the DLT rate is closest to the target DLT rate of 0.25. If a tie exists between potential doses the higher dose level will be selected when the isotonic estimate is lower than the target DLT rate and the lower dose level will be selected when the isotonic estimate is greater than or equal to the target DLT rate. If the observed DLT rate at the current dose is ≤ 0.197, escalate the dose to the next higher dose level. If the observed DLT rate at the current dose is \> 0.298, de-escalate the dose to the next lower dose level. Otherwise, stay at the current dose level. |
| Secondary | Changes in Acetylation of Peripheral Blood Mononuclear Cell Histones, H3 and H4, During Treatment | Up to 20 months | Peripheral blood samples collected at baseline and during treatment will be analyzed for changes in acetylation of peripheral blood mononuclear cell (PBMC) histones H3 and H4. |
| Secondary | Changes in Acetylation of Histones, H3 and H4, Using Peripheral Blood Exosomes | Up to 20 months | Peripheral blood samples collected at baseline and during treatment will be analyzed for changes in acetylation of peripheral blood mononuclear cell (PBMC) histones, H3 and H4, using peripheral blood exosomes. |
| Secondary | Progression-free Survival | 36 months | Progression-free survival (PFS), the time from treatment initiation to disease progression, will be estimated using the Kaplan-Meier method. |
| Secondary | Overall Survival (OS) | 36 months | Overall survival (OS), the time from treatment initiation to death from any cause, will be estimated using the Kaplan-Meier method. |
| Secondary | Descriptive examination of patient quality of life during treatment (EORTC QLQ-C30) | 24 months | Participant Quality of Life (QOL) will be measured throughout treatment using the European Organization for the Research and Treatment of Cancer Quality of Life (EORTC QLQ-BN30) questionnaire. Question responses range from 1 (Not at All) to 4 (Quite a Bit). Higher scores indicate greater functioning. Two additional questions ask participants to rate overall health and quality of life using a scale ranging from 1 to 7, where higher numbers indicate more favorable outcomes. |
| Secondary | Descriptive Examination of Participant Quality of Life During Treatment (EORTC QLQ-BN20) | 24 months | Participant Quality of Life (QOL) will be measured throughout treatment using the European Organization for the Research and Treatment of Cancer Quality of Life (EORTC QLQ-BN20) questionnaire. Question responses range from 1 (Not at All) to 4 (Quite a Bit). Higher scores indicate greater functioning. |
| Secondary | Measurement of Tumor Response | Up to 36 months | Magnetic resonance imaging (MRI) and clinical features will be used to classify tumor response as one of four categories that range from complete response to disease progression. The overall response will be assessed using Response Assessment in Neuro-Oncology (RANO) Criteria. |
| Secondary | Correlation of Molecular Profiles With Tumor Response | Up to 36 months | The correlation of tumor response and peripheral blood mononuclear cells (PBMC) and exosomes extracted from peripheral blood samples will be determined. |
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.
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