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Alkylating agents

PCI-24781 + Temozolomide for Recurrent Brain Cancer

Phase 1
Led By Nicole Shonka, MD
Research Sponsored by University of Nebraska
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Screening 3 weeks
Treatment Varies
Follow Up 36 months
Awards & highlights

Study Summary

This trial aims to find a better treatment for glioma, a type of brain cancer. It studies the effects of combining PCI-24781 and metronomic temozolomide to see if it can help those whose cancer has returned.

Who is the study for?
This trial is for adults over 19 with recurrent high-grade glioma who've had prior radiation and temozolomide treatment. They must have good liver, kidney, and bone marrow function, not be pregnant or nursing, and agree to use birth control. Excluded are those with certain heart conditions, other active cancers (except some skin/prostate), specific infections or systemic illnesses that could affect safety.Check my eligibility
What is being tested?
The study tests the combination of a drug called PCI-24781 with low-dose Temozolomide in patients whose brain cancer has returned. It aims to find the safest dose of this combo and assess its side effects in treating high-grade gliomas like astrocytoma or glioblastoma.See study design
What are the potential side effects?
Potential side effects include those commonly associated with chemotherapy such as nausea, fatigue, blood cell count changes leading to increased infection risk or bleeding problems. Specific side effects related to PCI-24781 may also occur but are being studied.


Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Determine the recommended dose of PCI-24781/Abexinostat
Evaluation of toxicities associated with PCI-24781/Abexinostat and metronomic temozolomide therapy (AEs & SAEs)
Evaluation of toxicities associated with PCI-24781/Abexinostat and metronomic temozolomide therapy (overall, graded 1-5)
Secondary outcome measures
Correlation of molecular profiles with tumor response
Descriptive examination of patient quality of life (QOL) during treatment - EORTC QLQ-BN20 Questionnaire
Descriptive examination of patient quality of life (QOL) during treatment - EORTC QLQ-C30 Questionnaire
+5 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Single armExperimental Treatment2 Interventions
Patients will receive a combination of PCI-24781/Abexinostat and temozolomide. Patients will receive a loading dose of PCI-24781/Abexinostat prior to the start of Cycle 1; patients will take PCI-24781/Abexinostat by mouth twice a day starting 7 days prior to Cycle 1, Day 1 and ending 4 days prior to Cycle 1, Day 1. Patients will continue taking PCI-24781/Abexinostat on days 1-4, 8-11, 15-18, and 22-25 of each 28 day cycle, starting with Cycle 1, Day 1. The initial dose level is 60 mg of PCI-2478/Abexinostat 1 by mouth twice daily. The dose level may be escalated based on results of interim data analysis. Patients will additionally initiate metronomic temozolomide on Cycle 1, Day 1 at a dose of 50 mg/m2, taken by mouth twice daily. Patients will continue the PCI-24781/Abexinostat and metronomic temozolomide regimen until disease progression or intolerance.
First Studied
Drug Approval Stage
How many patients have taken this drug
Completed Phase 3

Find a Location

Who is running the clinical trial?

University of NebraskaLead Sponsor
539 Previous Clinical Trials
1,144,716 Total Patients Enrolled
Xynomic Pharmaceuticals, Inc.Industry Sponsor
10 Previous Clinical Trials
1,191 Total Patients Enrolled
Nicole Shonka, MDPrincipal InvestigatorUniversity of Nebraska
5 Previous Clinical Trials
100 Total Patients Enrolled

Media Library

Temozolomide (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT05698524 — Phase 1
Brain Tumor Research Study Groups: Single arm
Brain Tumor Clinical Trial 2023: Temozolomide Highlights & Side Effects. Trial Name: NCT05698524 — Phase 1
Temozolomide (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05698524 — Phase 1

Frequently Asked Questions

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

Has the FDA given clearance to any single arm trials?

"As Single Arm is in its earliest phase of research, this medication's safety has been rated a 1 due to the limited data available on efficacy and safety."

Answered by AI

Is the research team currently seeking new participants for this experiment?

"Affirmative. According to the information hosted on clinicaltrials.gov, this exploratory medical trial is actively searching for 18 participants from one location. The study was first posted on June 26th 2023 and updated most recently on July 10th 2023."

Answered by AI

What is the approximate size of the population being treated as part of this investigation?

"Yes, according to clinicaltrials.gov this study is actively enrolling participants with the first post on June 26th 2023 and last update occurring July 10th 20203. The current goal is to secure eighteen patients from one location."

Answered by AI

What results are investigators striving to achieve with this medical experiment?

"As the primary outcome, this study aims to ascertain an optimal dosage of PCI-24781 over a 25 month period. Secondary objectives focus on estimating progression-free survival through Kaplan Meier analysis and examining patient quality of life using EORTC QLQ-BN20 scoring system as well as gauging tumor response via RANO Criteria."

Answered by AI
~9 spots leftby Feb 2025