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Histone Deacetylase (HDAC) Inhibitor

Fimepinostat for Brain Cancer (PNOC016 Trial)

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
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My kidney and liver functions meet the required levels for my age and gender.
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I can swallow pills without needing to crush or chew them.
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My diarrhea is mild and manageable.
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My diagnosis has been confirmed by examining tissue under a microscope.
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My body surface area is at least 0.5 square meters.
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I have enough tissue collected for testing, about 4-6 core biopsies worth.

PNOC016 Trial Timeline

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
~9870

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
~5 spots leftby Jun 2025
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