Trials Sponsors Conditions Drugs Pricing

Conditions

Glioblastoma WHO Grade IV

Keywords

IDH-WT

Outcome Measures

Primary Outcomes (2)

Quisinostat Concentration in Tumor Tissue
Total and unbound quisinostat concentration will be quantified in Gd-enhancing and Gd-non-enhancing tumor tissue collected during Phase 0 surgery.
Phase 0 surgery
6-Month Progression Free Survival (PFS6) Rate in Participants
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.
From date of Phase 0 surgery to date of disease recurrence or death, assessed over 16 months

Secondary Outcomes (7)

Quisinostat Concentration in Cerebrospinal Fluid (CSF)
From date of Phase 0 surgery through study completion, assessed over 4 months
Number of Participants with Drug-Related Toxicity
From date of first dose until 30 days after last dose, assessed over 4 months
Number of Treatment-Emergent Adverse Events
From date of enrollment until 30 days after last dose, assessed over 6 months
Number of Treatment-Related Adverse Events
From date of first dose until 30 days after last dose, assessed over 4 months
Number of Participants with Clinical Laboratory Abnormalities
From date of first dose until 30 days after last dose, assessed over 4 months
+2 more secondary outcomes

Other Outcomes (9)

Systemic PK: Peak Plasma Concentration (Cmax)
From date of first dose until standard of care post-op follow-up visit, assessed over 1 month
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
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
+6 more other outcomes

Study Arms (2)

Recurrent WHO Grade 4 Glioblastoma IDH-WT

EXPERIMENTAL

Drug: Quisinostat

Newly-Diagnosed WHO Grade 4 Glioblastoma IDH-WT

EXPERIMENTAL

Drug: Quisinostat

Interventions

QuisinostatDrug

a highly potent and orally active HDAC inhibitor

Newly-Diagnosed WHO Grade 4 Glioblastoma IDH-WTRecurrent WHO Grade 4 Glioblastoma IDH-WT

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

For Arm A: Participants who have had a prior resection of diagnosed glioblastoma, IDH wildtype (2021 WHO grade 4), defined as participants who have progressed on or following standard therapy, which includes maximal surgical resection, temozolomide, and fractionated radiotherapy. Participants will also need to have radiation planned as part of the post-surgical treatment plan; OR, for Arm B only: Participants undergoing resection for a suspected newly diagnosed WHO Grade 4 glioblastoma, IDH wildtype. Participants will also need to have radiation planned as part of the post-surgical treatment plan.

Sponsors & Collaborators

Nader Sanai
Otherlead

Study Sites (1)

St. Joseph's Hospital and Medical Center

Phoenix, Arizona, 85013, United States

MeSH Terms

Interventions

quisinostat

Study Officials

Nader Sanai, MD
Ivy Brain Tumor Center
PRINCIPAL INVESTIGATOR

Study Design

Study Type: interventional
Phase: early phase 1
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR INVESTIGATOR
PI Title: Director, Ivy Brain Tumor Center

Study Record Dates

First Submitted

February 4, 2025

First Posted

February 13, 2025

Study Start

September 4, 2025

Actual (reported)

Primary Completion

July 15, 2026

Estimated (date passed)

You may not qualify if:

Pregnancy or lactation.
Known allergic reactions to components of the quisinostat.
Known to have active (acute or chronic) or uncontrolled severe infection, liver disease such as cirrhosis, decompensated liver disease, and active and chronic hepatitis, as determined by the investigator.
Known active systemic bacterial infection (requiring intravenous \[IV\] antibiotics or fever \>38.5°C at time of initiating study treatment), fungal infection, or detectable viral infection (such as known human immunodeficiency virus positivity or with known active hepatitis B or C \[for example, hepatitis B surface antigen positive\]. Screening of viral infection is not required for enrollment.
The participant has a personal history of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest.
Any of the following cardiac criteria: cardiac dysfunction defined as myocardial infarction within six months of study entry, NYHA Class II/III/IV heart failure, unstable angina or unstable cardiac arrhythmias; mean resting corrected QT interval (QTcF) \> 470 msec obtained from 3 electrocardiograms (ECGs) (QTc interval will be calculated using Fridericia's formula); any clinically important abnormalities in rhythm, conduction or morphology of resting ECG, e.g., complete left bundle branch block, third degree heart block; any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years-of-age (patients stable on concomitant medications known to prolong the QT interval may be allowed to participate in the study provided that their mean resting corrected QT interval (QTcF) is \< 450 msec in males or \< 470msec in females at baseline and after discussion with the Principal Investigator); use of medications that may cause Torsades de Pointes.
History or presence of myopathy or raised creatine kinase (CK) \> 5 x upper limit of normal (ULN) on 2 occasions at screening.
Participant has serious and/or uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study (for example, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, severe renal impairment \[e.g. estimated creatinine clearance \<30 ml/min\], history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea).
Prior therapy with histone-deacetylase inhibitor therapy; more than 3 prior lines of therapy.
Treatment with strong inhibitors or inducers of CYP3A4 within 2 weeks prior to receiving study drug.
Prior treatment with pneumotoxic drugs, e.g. busulfan, bleomycin, within the past year. If prior therapy in lifetime, then excluded if history of pulmonary toxicities from administration. Patients who have received treatment with nitrosoureas (e.g., BCNU, CCNU) in the year before study entry without experiencing lung toxicity are allowed on study.
Treatment with another investigational drug or other intervention within 5 half-lives of the investigational product, whichever is longer.
With the exception of alopecia, any unresolved toxicities from prior therapy greater than National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 5.0) Grade 1 at the time of starting study treatment and patients with chronic Grade 2 unresolved toxicities may be eligible following discussion with the Principal Investigator.

Phase 0 With Expansion Phase Clinical Trial of Quisinostat Plus Radiotherapy in Newly-diagnosed and Recurrent Grade 4 IDH-Wildtype Glioblastomas

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (7)

Other Outcomes (9)

Study Arms (2)

Recurrent WHO Grade 4 Glioblastoma IDH-WT

Newly-Diagnosed WHO Grade 4 Glioblastoma IDH-WT

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (7)

Other Outcomes (9)

Study Arms (2)

Recurrent WHO Grade 4 Glioblastoma IDH-WT

Newly-Diagnosed WHO Grade 4 Glioblastoma IDH-WT

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations