Trial · NCT06824662
Phase 0 With Expansion Phase Clinical Trial of Quisinostat Plus Radiotherapy in Newly-diagnosed and Recurrent Grade 4 IDH-Wildtype Glioblastomas
NCT06824662, Early phase 1, Active not recruiting, Nader Sanai
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase 0 With Expansion Phase Clinical Trial of Quisinostat Plus Radiotherapy in Newly-diagnosed and Recurrent Grade 4 IDH-Wildtype Glioblastomas. Trials, record NCT06824662. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06824662
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase 0 With Expansion Phase Clinical Trial of Quisinostat Plus Radiotherapy in Newly-diagnosed and Recurrent Grade 4 IDH-Wildtype Glioblastomas
- NCT number
- NCT06824662
- Status
- Active not recruiting
- Phases
- Early phase 1
- Enrollment
- 30 participants, estimated
- Lead sponsor
- Nader Sanai
- Conditions
- Glioblastoma WHO Grade IV
- Interventions
- Quisinostat
- First posted
- 2025-02-13
- Last updated
- 2026-03-17
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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. |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06824662
GET https://conductscience.org/api/trials/v1/NCT06824662/registered