Trial · NCT06824662
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Quisinostat Concentration in Tumor Tissue | Phase 0 surgery | Total and unbound quisinostat concentration will be quantified in Gd-enhancing and Gd-non-enhancing tumor tissue collected during Phase 0 surgery. |
| Primary | 6-Month Progression Free Survival (PFS6) Rate in Participants | From date of Phase 0 surgery to date of disease recurrence or death, assessed over 16 months | The rate of 6-month progression-free survival of participants that had a positive PK response (defined as unbound concentrations of quisinostat equal or greater than 0.5 nM in Gd-non-enhancing tumor tissue) will be quantified. |
| Secondary | Quisinostat Concentration in Cerebrospinal Fluid (CSF) | From date of Phase 0 surgery through study completion, assessed over 4 months | Quisinostat concentration will be quantified in cerebrospinal fluid collected during Phase 0 surgery and throughout study duration of participants with an Ommaya reservoir and shunt placed during surgery. |
| Secondary | Number of Participants with Drug-Related Toxicity | From date of first dose until 30 days after last dose, assessed over 4 months | Safety and tolerability of quisinostat will be assessed by tabulating the number of drug-related toxicities (graded per CTCAE version 5) which include: * Grade 2 or higher cardiac disorder * Grade 4 or higher hematological or nonhematological toxicity * Febrile neutropenia * Unacceptable toxicity as determined by the Investigator * Any Grade 3 or higher non-hematologic toxicity, excluding the following: Grade 3 nausea, vomiting, or diarrhea for less than 72 hours with adequate supportive care; Grade 3 fatigue for longer than 1 week; Grade 3 or higher electrolyte abnormality lasting up to 72 hours, is not clinically complicated, and resolves spontaneously or responds to conventional treatment |
| Secondary | Number of Treatment-Emergent Adverse Events | From date of enrollment until 30 days after last dose, assessed over 6 months | Safety and tolerability of quisinostat will be assessed by tabulating participants that had treatment-emergent adverse events according to the highest Grade observed per patient for each event or category (graded per CTCAE version 5). |
| Secondary | Number of Treatment-Related Adverse Events | From date of first dose until 30 days after last dose, assessed over 4 months | Safety and tolerability of quisinostat will be assessed by tabulating participants that had treatment-related adverse events (defined as those events definitely, probably, or potentially related to study treatment) according to the highest Grade observed per patient for each event or category (graded per CTCAE version 5). |
| Secondary | Number of Participants with Clinical Laboratory Abnormalities | From date of first dose until 30 days after last dose, assessed over 4 months | Safety and tolerability of quisinostat will be assessed by tabulating participants that had clinical laboratory abnormalities stratified by each event or abnormal result. |
| Secondary | Number of Serious Adverse Events and Deaths | From date of enrollment until 30 days after last dose, assessed over 6 months | Safety and tolerability of quisinostat will be assessed by aggregating and tabulating participants that died during study participation (due to any cause), and participants that had serious adverse events according to the highest Grade observed per patient for each event or category (graded per CTCAE version 5). |
| Secondary | Overall Survival during Expansion Phase | From date of surgery until death, assessed up to 16 months | Overall Survival of participants that had a positive PK response (defined as unbound concentrations of quisinostat equal or greater than 0.5 nM in Gd-non-enhancing tumor tissue) will be summarized using Kaplan-Meier Curves and Estimates. |
| Other | Systemic PK: Peak Plasma Concentration (Cmax) | From date of first dose until standard of care post-op follow-up visit, assessed over 1 month | Peak plasma concentration (Cmax) of total and unbound quisinostat levels will be quantified. |
| Other | Systemic PK: Time to Peak Plasma Concentration (Tmax) | From date of first dose until standard of care post-op follow-up visit, assessed over 1 month | Time to peak plasma concentration (Tmax) of total and unbound quisinostat levels will be quantified. |
| Other | Systemic PK: Quisinostat Half-Life (T1/2) in Plasma | From date of first dose until standard of care post-op follow-up visit, assessed over 1 month | The half-life (T1/2) of total and unbound quisinostat levels in plasma will be quantified. |
| Other | Systemic PK: Area Under Time/Concentration Curve (AUC0-24) in Plasma | From time of last dose assessed over 24 hours | Area under the time/concentration curve (AUC0-24) over 24 hours of total and unbound quisinostat levels in plasma will be quantified. |
| Other | Total (Kp) and Unbound (Kp,uu) Partition Coefficient of Quisinostat | From date of first dose to 30 days after last Phase 0 dose, assessed over 2 months | The tumor to plasma partition coefficients of quisinostat for total (Kp) and unbound (Kp,uu) drug levels will be quantified. |
| Other | Change in Biomarker Concentrations in Tumor Tissue | Baseline, Phase 0 surgery | Tumor tissue collected during surgery will be compared to baseline tissue to assess fold induction change of AcH3K9/14, pH2AX, ClCas-3, and MIB-1. |
| Other | Changes in Cell State and Gene Expression of Tumor Tissue | Phase 0 surgery, subsequent surgery(ies) | Tumor tissue collected at subsequent resections (if any) will be compared to tumor tissue collected during Phase 0 surgery to determine changes in cell state and gene expression using single-cell RNA-seq analysis. |
| Other | Genomic Changes of DNA in CSF | Baseline, Phase 0 surgery, post-op follow-up, day 1 of each cycle assessed over 3 months | Genomic changes will be assessed by sequencing DNA from tumor cells and/or cell-free DNA in CSF collected during Phase 0 surgery and throughout study duration of participants with an Ommaya reservoir and shunt placed during surgery. |
| Other | Transcriptome Changes of RNA in CSF | Baseline, Phase 0 surgery, post-op follow-up, day 1 of each cycle assessed over 3 months | Transcriptomic changes will be assessed by sequencing RNA from tumor cells in CSF collected during Phase 0 surgery and throughout study duration of participants with an Ommaya reservoir and shunt placed during surgery. |
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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