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Apoptosis Inducer

Xevinapant for Recurrent Brain Tumors

Phase 1

Waitlist Available

Led By Arnold Etame, MD, PhD

Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute

Eligibility Criteria Checklist

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

Must have

Patient must have Karnofsky performance status (KPS) of ≥70 or Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1

Able to swallow liquids or has an adequately functioning feeding tube, gastrostomy or jejunostomy placed

Must not have

Other infections requiring systemic treatment

Live-attenuated vaccinations within 30 days prior to first investigational treatment administration

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months.

Awards & highlights

No Placebo-Only Group

Summary

This trial will study whether Xevinapant can enter the brain and effectively fight tumors by causing cancer cell death. The researchers believe that taking Xevinapant by mouth is safe for patients with recurrent

Who is the study for?

This trial is for individuals with recurrent high-grade glioma (rHGG), a type of brain tumor. Participants must be scheduled for surgery to remove their tumors and able to take oral medication.

What is being tested?

The study tests Xevinapant's ability to reach the brain tumor and promote cancer cell death by triggering apoptosis. It's an early-phase trial where patients will take Xevinapant before their planned surgery to assess its effects on the tumor.

What are the potential side effects?

While specific side effects are not listed, as this is an early-phase trial, potential side effects may include typical reactions to new cancer medications such as nausea, fatigue, headache, or other drug-related complications.

Eligibility Criteria

Inclusion Criteria

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

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I am mostly able to care for myself and perform daily activities.

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I can swallow liquids or have a working feeding tube.

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My tumor shows up on scans and can be surgically removed.

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I have been diagnosed with a high-grade brain tumor.

Exclusion Criteria

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

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I am currently on medication for an infection.

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I have not received any live vaccines in the last 30 days.

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I do not have an active hepatitis B or C infection.

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I haven't needed more than 2 blood transfusions in the last month due to bleeding.

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I have heart problems or significant heart disease.

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I need oxygen regularly for my lung condition.

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I have lost more than 10% of my weight in the last month or my blood albumin levels are below 3.0 g/dL.

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I do not have HIV.

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I have not needed IV antibiotics for an infection in the last week.

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I am currently taking medication for an uncontrolled inflammatory disease.

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I am taking medication that affects my heart's rhythm and cannot stop it before treatment.

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My liver disease is severe and affects my daily life.

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I have a digestive condition that affects how my body absorbs medicine.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 months.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 months.

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months. for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Concentration max (Cmax)

Concentration of Xevinapant

Secondary study objectives

Occurrence of AE's and SAE's

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: Xevinapant TreatmentExperimental Treatment1 Intervention

Participants will be given a course of orally administered Xevinapant at 400 mg once daily for 4 consecutive days, prior to undergoing clinically indicated tumor resection.

0 / 17Eligibility criteria met