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Selective Inhibitor of Nuclear Export

Selinexor + Temozolomide for Recurrent Glioblastoma

Phase 1 & 2

Waitlist Available

Led By Frances E Chow

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

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

Must have

Patients must have received first-line treatment of temozolomide plus radiotherapy

Age >= 18 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

Study Summary

This trialtests if a drug combo can better treat recurrent glioblastoma than chemo alone.

Who is the study for?

Adults with recurrent glioblastoma who've had prior temozolomide and radiotherapy can join. They must have measurable disease, adequate organ function, and a Karnofsky performance status of at least 60%. HIV-positive patients on effective therapy, those cured of hepatitis C, or with controlled hepatitis B are eligible. Pregnant women and breastfeeding mothers cannot participate; others must use contraception.Check my eligibility

What is being tested?

The trial is testing the safety and effectiveness of adding Selinexor to standard chemotherapy (Temozolomide) for recurrent brain tumors. It's assessing if this combination better controls tumor growth compared to Temozolomide alone.See study design

What are the potential side effects?

Selinexor may cause fatigue, nausea, loss of appetite, blood count changes, and other organ-related side effects. Temozolomide can lead to similar issues including headaches, constipation or diarrhea, dizziness, and potential hair loss.

Eligibility Criteria

Inclusion Criteria

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

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I have received temozolomide and radiotherapy as my first treatment.

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I am 18 years old or older.

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My kidney function is normal or only mildly reduced.

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I have chronic hepatitis B but it's under control with medication.

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My heart condition does not severely limit my physical activity.

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My glioblastoma was confirmed with a biopsy and has specific genetic features.

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I had hepatitis C but am now cured or have no detectable virus while on treatment.

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I have only had surgery or a biopsy for my recurring disease, no other treatments.

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

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My cancer can be measured by tests before any surgery or biopsy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Progression-free survival (PFS) (Phase II)

Recommended phase 2 dose (RP2D) (Phase I)

Secondary outcome measures

Median overall survival

Molecular signatures of vulnerability

Response according to response assessment in neuro-oncology criteria (RANO) criteria

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Group II (temozolomide, selinexor)Experimental Treatment4 Interventions

Patients receive temozolomide PO on days 1-5 of each cycle and selinexor PO on days 8 and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo MRI throughout the study and blood sample collection while on study.

Group II: Group I (temozolomide)Active Control3 Interventions

Patients receive temozolomide PO on days 1-5 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo MRI throughout the study and blood sample collection while on study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Magnetic Resonance Imaging

2017

Completed Phase 3

~1190

Biospecimen Collection

2004

Completed Phase 2

~1730

Selinexor

2020

Completed Phase 2

~1360

Temozolomide

2010

Completed Phase 3

~1930

0 / 10Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,658 Previous Clinical Trials

40,924,544 Total Patients Enrolled

322 Trials studying Glioblastoma

23,018 Patients Enrolled for Glioblastoma

Frances E ChowPrincipal InvestigatorCity of Hope Comprehensive Cancer Center LAO

Media Library

Selinexor (Selective Inhibitor of Nuclear Export) Clinical Trial Eligibility Overview. Trial Name: NCT05432804 — Phase 1 & 2

Glioblastoma Research Study Groups: Group I (temozolomide), Group II (temozolomide, selinexor)

Glioblastoma Clinical Trial 2023: Selinexor Highlights & Side Effects. Trial Name: NCT05432804 — Phase 1 & 2

Selinexor (Selective Inhibitor of Nuclear Export) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05432804 — Phase 1 & 2

Frequently Asked Questions

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

How many individuals have become participants of this clinical trial?

"Affirmative. The evidence on clinicaltrials.gov confirms that this trial is actively recruiting individuals for participation, which was initially announced on October 13th 2022 and recently updated on the 19th of October. A total of 24 patients are needed from a single location."

Answered by AI

Are there remaining vacancies in this clinical trial?

"Yes, the clinicaltrials.gov website confirms that this medical research is currently recruiting for 24 patients from a single centre. It was initially posted on October 13th 2022 and last modified on October 19th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Testing the Addition of an Anti-cancer Drug, Selinexor, to the Usual Chemotherapy Treatment (Temozolomide) for Brain Tumors That Have Returned After Previous Treatment

2023. "Testing the Addition of an Anti-cancer Drug, Selinexor, to the Usual Chemotherapy Treatment (Temozolomide) for Brain Tumors That Have Returned After Previous Treatment". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05432804.