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APG-157 + Bevacizumab for Brain Tumor

Phase 1 & 2

Recruiting

Led By Joon Uhm, MD

Research Sponsored by Aveta Biomics, Inc.

Eligibility Criteria Checklist

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

Must have

Patients must have pathologically proven diagnosis of high grade (aka grade III or IV) glioma that has progressed on bevacizumab (anaplastic astrocytoma, anaplastic oligodendroglioma, glioblastoma, gliosarcoma, H3K27M mutant glioma)

Physiologic Status/Age: Patients must be 19 years of age or older (the age of consent in Nebraska)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up every 8 weeks; from date of commencement of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months

Awards & highlights

Study Summary

This trial will test a combination of two drugs to see if they can help people with a type of brain tumor live longer and improve their quality of life.

Who is the study for?

This trial is for adults (19+) with high-grade glioma brain tumors that have worsened despite previous treatments including Bevacizumab, radiation, and temozolomide. Participants must be in stable health otherwise, with good organ function and blood counts. Pregnant or nursing women can't join, nor those with recent heart issues or surgeries.Check my eligibility

What is being tested?

The study tests APG-157 pastilles taken orally three times daily alongside standard Bevacizumab treatment. It aims to assess the combination's impact on tumor progression, patient survival rates, quality of life, and changes observed in imaging studies.See study design

What are the potential side effects?

While specific side effects of APG-157 aren't listed here, common risks may include mouth sores from dissolving pastilles and typical Bevacizumab-related side effects like hypertension, bleeding problems, wound healing complications, and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

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

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My high-grade brain tumor has worsened despite bevacizumab treatment.

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I am 19 years old or older.

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My blood tests show enough white cells, hemoglobin, and platelets.

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My kidney function is within the normal range based on creatinine levels.

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I am not pregnant or nursing and agree to use birth control during and 6 months after the study.

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I can care for myself but may not be able to do heavy physical work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ every 8 weeks; from date of commencement of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~every 8 weeks; from date of commencement of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and every 8 weeks; from date of commencement of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 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

Overall Survival

Progression-free Survival

Secondary outcome measures

Pharmacokinetics (PK) of APG-157

QOL assessment (EORTC QLQ-C30)

Radiographic studies MRI or CT of the brain

Trial Design

1Treatment groups

Experimental Treatment

Group I: APG-157Experimental Treatment1 Intervention

The participants will receive APG-157 daily by taking two pastilles in their mouth at around breakfast, lunch and dinner time (total of six pastilles per day). The pastilles dissolve in the mouth. The participants will continue to receive Bevacizumab as standard of care.

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Aveta Biomics, Inc.Lead Sponsor

3 Previous Clinical Trials

56 Total Patients Enrolled

1 Trials studying Glioblastoma

Joon Uhm, MDPrincipal InvestigatorMayo Clinic

Nicole Shonka, MDPrincipal InvestigatorUniversity of Nebraska

5 Previous Clinical Trials

88 Total Patients Enrolled

3 Trials studying Glioblastoma

41 Patients Enrolled for Glioblastoma

Frequently Asked Questions

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

Are there still opportunities to enroll in this investigation?

"According to clinicaltrials.gov, this experiment is not currently seeking participants, as the posting was last amended on August 23rd 2023. Nonetheless, there are still 759 other medical studies actively recruiting patients at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Treatment of Patients With Recurrent High-Grade Glioma With APG-157 and Bevacizumab

2023. "Treatment of Patients With Recurrent High-Grade Glioma With APG-157 and Bevacizumab". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06011109.

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