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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

Must not have

Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situation that would limit compliance with study requirements

Patients must not have received prior therapy with single-agent or combination histone deacetylase (HDAC) and Phosphatidylinositol-4,5-bisphosphate 3-kinase (PI3K) inhibitors

Timeline

Screening 3 weeks

Treatment Varies

Follow Up during surgery or biopsy

Awards & highlights

No Placebo-Only Group

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any serious illnesses or social situations that would stop me from following the study's requirements.

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I have not been treated with HDAC or PI3K inhibitors before.

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I have HIV with risks from immune-suppressive therapy.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Penetration of fimepinostat across the blood brain barrier (BBB)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~9930

0 / 9Eligibility criteria met