Suspended

Selinexor, Temozolomide and Radiation Therapy for Newly Diagnosed Glioblastoma and Gliosarcoma

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What is being tested

Selinexor

+ Temozolomide

+ Generic Radiation therapy (RT)

DrugRadiationOtherDietary Supplement
Who is being recruted

Astrocytoma+8

+ Glioblastoma

+ Glioma

Over 18 Years
+18 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: July 2020
See protocol details

Summary

Principal SponsorNational Cancer Institute (NCI)
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: July 7, 2020

Actual date on which the first participant was enrolled.

This clinical trial focuses on improving treatment for a type of brain tumor called glioblastoma and gliosarcoma. Currently, even with surgery, radiation, and a drug called temozolomide, the survival rate remains low due to the tumor's resistance to radiation. The study introduces a new drug, Selinexor, which has shown potential in making glioma cells more sensitive to radiation. The main goal is to evaluate the safety and the highest tolerable dose of Selinexor when used alongside temozolomide and radiation therapy in adults newly diagnosed with glioblastoma and gliosarcoma. The trial follows a '3 plus 3 design' with three dose escalation levels, enrolling three patients per dose level. Participants will undergo standard external beam radiation therapy and daily temozolomide. Selinexor will be administered concurrently. The primary outcome is to determine the maximum tolerated dose of Selinexor, defined as the dose where no more than one out of six participants experience severe side effects within a month of treatment completion. The study anticipates enrolling up to 24 patients over approximately two years.

Official TitleA Phase I Clinical Trial of Selinexor (KPT-330) in Combination With Temozolomide and Radiation Therapy in Patients With Newly Diagnosed Glioblastoma
NCT04216329
Principal SponsorNational Cancer Institute (NCI)
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

11 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AstrocytomaGlioblastomaGliomaNeoplasmsNeoplasms by Histologic TypeNeoplasms, Germ Cell and EmbryonalNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueNeuroectodermal TumorsNeoplasms, NeuroepithelialGliosarcoma

Criteria

8 inclusion criteria required to participate
Ability of subject or Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent document.
Patients must have had surgery and/or biopsy not greater than 8 weeks prior to initial evaluation to be eligible for this study.
Histological diagnosis: Pathologically confirmed glioblastoma or gliosarcoma (including astrocytoma, grade IV)
Patients must be eligible for definitive external beam radiotherapy and temozolomide.
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10 exclusion criteria prevent from participating
Patients must not have significantly diseased or obstructed gastrointestinal tract malabsorption, uncontrolled vomiting or diarrhea, or inability to swallow oral medication.
Pregnant women are excluded from this study because Selinexor could have the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with Selinexor, breastfeeding should be discontinued if the mother is treated with Selinexor. These potential risks may also apply to temozolomide used in this study.
Patients who are receiving any other investigational agents and have had prior therapy including: patients who have previously received radiation therapy (RT) to the brain, patients who received chemotherapy for the treatment of their glioma, patients who are being treated with implanted Gliadel wafers, patients who are being treated with tumor treating fields.
History of allergic reactions attributed to compounds of similar chemical or biologic composition to selinexor or temozolomide used in study.
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Selinexor with temozolomide and radiation

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

National Institutes of Health Clinical Center

Bethesda, United StatesOpen National Institutes of Health Clinical Center in Google Maps
SuspendedOne Study Center