← Back to Search

Histone Deacetylase (HDAC) Inhibitor

Fimepinostat for Brain Cancer (PNOC016 Trial)

Q: Is this the inaugural endeavor of its kind?

To date, there are two distinct trials involving the use of Fimepinostat across 19 cities and 2 countries. In 2016, Curis Inc. began a Phase 1 study with 44 patients that successfully completed its drug approval process; since then 36 other trials have been conducted.

Q: What is the enrollment size for this experiment?

Unfortunately, this trial is not presently recruiting individuals. It was initially uploaded on August 7th 2019 and last edited a year ago, on August 16th 2022. For those seeking other studies; currently there are 1,658 clinical trials for diffuse intrinsic pontine <a href="https://www.withpower.com/clinical-trials/glioma">glioma</a> and two more for Fimepinostat that require participants to join.

Q: Is this investigation still open for participants?

This medical experiment is not presently searching for participants. Originally posted on August 7th 2019, the trial was last updated on August 16th 2022. For those still looking to participate in studies, there are currently 1658 experiments pertaining to Diffuse Intrinsic Pontine <a href="https://www.withpower.com/clinical-trials/glioma">Glioma</a> and 2 that involve Fimepinostat actively admitting patients.

Q: Is it possible for me to partake in this research initiative?

This medical experiment is accepting 30 individuals with diffuse intrinsic pontine <a href="https://www.withpower.com/clinical-trials/glioma">glioma</a> aged 3 to 39. To be eligible, participants must meet the following criteria: Stratum B necessitates recurrent <a href="https://www.withpower.com/clinical-trials/medulloblastoma">medulloblastoma</a> (WHO grade IV), any molecular subtype that are able to ingest intact fimepinostat capsules or mini-tabs without crushing them; Stratum B &#x26; C requires either recurring medulloblastoma and HGG arm with locally recurrent or disseminated disease, supported by imaging/Cerebrospinal fluid cytology for DIPG enrollees; Newly diagnosed DIPG candidates in Stratum A do not

Q: How many locations are engaged in this research endeavor?

19 medical centres are running this trial, including the notable Johns Hopkins Hospital in San Francisco, University of <a href="https://www.withpower.com/clinical-trials/california">California</a>, San Francisco in Ann Arbor and University of <a href="https://www.withpower.com/clinical-trials/michigan">Michigan</a> Hospital in Chicago. An additional 16 locations offer their study services as well.

Q: What other investigations have been conducted regarding the efficacy of Fimepinostat?

Currently, only 2 clinical studies are taking place to assess Fimepinostat and neither have progressed into the third phase. Despite this, 24 different medical sites across America are running trials with Fimepinostat; particularly in Baltimore.

Q: Is the age range for participation in this investigation confined to those over 25?

This trial is searching for individuals aged 3 to 39 years.

Phase < 1

Waitlist Available

Research Sponsored by Sabine Mueller, MD, PhD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must meet specific criteria for creatinine clearance or serum creatinine based on age/gender, bilirubin, SGPT/ALT, and serum albumin

Patients must be able to swallow intact fimepinostat capsules or mini-tabs without chewing or crushing

Timeline

Screening 3 weeks

Treatment Varies

Follow Up during surgery or biopsy

Awards & highlights

PNOC016 Trial Summary

This trial is testing how well fimepinostat works in treating patients with newly diagnosed brain tumors. Fimepinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Who is the study for?

This trial is for children and young adults with specific brain tumors (like diffuse intrinsic pontine glioma or high-grade glioma) that are newly diagnosed or have returned. Participants must be able to swallow medication, have recovered from previous cancer treatments, meet certain health criteria including controlled seizures if present, agree to use contraception, and understand the consent form.Check my eligibility

What is being tested?

The trial is testing fimepinostat's effectiveness on certain brain tumors by blocking enzymes needed for tumor cell growth. It includes patients who can take the drug orally and have met recovery benchmarks from prior treatments. The study also involves standard care tumor tissue collection.See study design

What are the potential side effects?

Potential side effects of fimepinostat may include changes in blood counts leading to increased infection risk, fatigue, digestive issues like diarrhea (must be less than grade 2), liver function alterations, and possibly others related to enzyme inhibition.

PNOC016 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My kidney and liver functions meet the required levels for my age and gender.

Select...

I can swallow pills without needing to crush or chew them.

Select...

My diarrhea is mild and manageable.

Select...

My diagnosis has been confirmed by examining tissue under a microscope.

Select...

My body surface area is at least 0.5 square meters.

Select...

I have enough tissue collected for testing, about 4-6 core biopsies worth.

PNOC016 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ during surgery or biopsy

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~during surgery or biopsy

This trial's timeline: 3 weeks for screening, Varies for treatment, and during surgery or biopsy for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Penetration of fimepinostat across the blood brain barrier (BBB)

PNOC016 Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (fimepinostat, tumor resection)Experimental Treatment2 Interventions

Patients receive fimepinostat by mouth once daily, on Days -2 to 0. Within 2 hours of receiving fimepinostat on Day 0, patients undergo tumor resection or biopsy as part of their standard of care. MAINTENANCE PHASE: Patients receive fimepinostat by mouth, once daily for days 1-5 each week. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity for up to 12 months from the time treatment begins. Should patients continue to derive clinical benefit, and not experience excess toxicity or progression, patients can continue to receive drug for up to 24 months or longer pending discussion with study chairs and study sponsor.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Therapeutic Conventional Surgery

2005

Completed Phase 3

~9850

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Cannonball Kids' Cancer FoundationOTHER

5 Previous Clinical Trials

127 Total Patients Enrolled

Sabine Mueller, MD, PhDLead Sponsor

8 Previous Clinical Trials

453 Total Patients Enrolled

Pacific Pediatric Neuro-Oncology ConsortiumOTHER

14 Previous Clinical Trials

707 Total Patients Enrolled

Media Library

Fimepinostat (Histone Deacetylase (HDAC) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03893487 — Phase < 1

Brain Tumor Research Study Groups: Treatment (fimepinostat, tumor resection)

Brain Tumor Clinical Trial 2023: Fimepinostat Highlights & Side Effects. Trial Name: NCT03893487 — Phase < 1

Fimepinostat (Histone Deacetylase (HDAC) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03893487 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this the inaugural endeavor of its kind?

"To date, there are two distinct trials involving the use of Fimepinostat across 19 cities and 2 countries. In 2016, Curis Inc. began a Phase 1 study with 44 patients that successfully completed its drug approval process; since then 36 other trials have been conducted."

Answered by AI

What is the enrollment size for this experiment?

"Unfortunately, this trial is not presently recruiting individuals. It was initially uploaded on August 7th 2019 and last edited a year ago, on August 16th 2022. For those seeking other studies; currently there are 1,658 clinical trials for diffuse intrinsic pontine glioma and two more for Fimepinostat that require participants to join."

Answered by AI

Is this investigation still open for participants?

"This medical experiment is not presently searching for participants. Originally posted on August 7th 2019, the trial was last updated on August 16th 2022. For those still looking to participate in studies, there are currently 1658 experiments pertaining to Diffuse Intrinsic Pontine Glioma and 2 that involve Fimepinostat actively admitting patients."

Answered by AI

Is it possible for me to partake in this research initiative?

"This medical experiment is accepting 30 individuals with diffuse intrinsic pontine glioma aged 3 to 39. To be eligible, participants must meet the following criteria: Stratum B necessitates recurrent medulloblastoma (WHO grade IV), any molecular subtype that are able to ingest intact fimepinostat capsules or mini-tabs without crushing them; Stratum B & C requires either recurring medulloblastoma and HGG arm with locally recurrent or disseminated disease, supported by imaging/Cerebrospinal fluid cytology for DIPG enrollees; Newly diagnosed DIPG candidates in Stratum A do not"

Answered by AI

How many locations are engaged in this research endeavor?

"19 medical centres are running this trial, including the notable Johns Hopkins Hospital in San Francisco, University of California, San Francisco in Ann Arbor and University of Michigan Hospital in Chicago. An additional 16 locations offer their study services as well."

Answered by AI

What other investigations have been conducted regarding the efficacy of Fimepinostat?

"Currently, only 2 clinical studies are taking place to assess Fimepinostat and neither have progressed into the third phase. Despite this, 24 different medical sites across America are running trials with Fimepinostat; particularly in Baltimore."

Answered by AI