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New drug cocktail aims to outsmart recurrent glioblastoma

NCT ID NCT05432804

Disease control Sponsor: National Cancer Institute (NCI) Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 18, 2026 · Updated 15 times

Summary

This study tests whether adding the drug selinexor to standard chemotherapy (temozolomide) can better control recurrent glioblastoma, an aggressive brain cancer. About 97 adults whose tumor has returned after initial treatment will receive either the combo or chemotherapy alone. The goal is to find the safest dose and see if the combination improves time without tumor growth.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
selinexor and temozolomide
What this could lead to
If successful, this combination could offer a new treatment option that slows or shrinks recurrent glioblastoma tumors better than standard chemotherapy alone.
What could go wrong
This is an early-phase trial (phase 1/2) with only 97 participants, so results may not apply broadly. Selinexor can cause side effects like nausea, fatigue, and low blood counts.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 97 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2023

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients must have histologically confirmed glioblastoma (IDH wild-type, MGMT promoter methylated) that has undergone resection or biopsy upon first recurrence. Recurrence at site of prior involvement is defined by histopathological evidence of viable neoplastic cells associated with any of the following: mitotic activity, increased proliferation rate, micro-endothelial proliferation, or pseudo-palisading necrosis * Prior to resection or biopsy, patients must have measurable disease, defined as at least one bi-dimensional contrast-enhancing lesion with clearly defined margins, with 2 perpendicular diameters of at least 10 mm, visible on \>= 2 axial slices * Patients must have received first-line treatment of temozolomide plus radiotherapy * Patients must not have received any prior therapy aside from resection or biopsy for their recurrent disease * Age \>= 18 years. Because no dosing or adverse event data are currently available on the use of selinexor (KPT-330) in combination with temozolomide in patients \< 18 years of age, children are excluded from this study * Karnofsky performance status \>= 60% (Eastern Cooperative Oncology Group \[ECOG\] =\< 2) * Absolute neutrophil count \>= 1,500/mcL * Platelets \>= 100,000/mcL * Hemoglobin \>= 10 g/dL * Total bilirubin =\< 2 x institutional upper limit of normal (ULN) * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine transaminase (ALT) (serum glutamic-pyruvic transaminase \[SGPT\]) =\< 3 x institutional ULN * Glomerular filtration rate (GFR) \>= 30 mL/min/1.73 m\^2 * Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial * For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated * Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load * Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial * Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better * The effects of selinexor (KPT-330) and temozolomide on the developing human fetus are unknown. For this reason and because selective nuclear export inhibitors as well as deoxyribonucleic acid (DNA) alkylating agents are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation, and for 180 days after the last dose of temozolomide. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 90 days after completion of study treatment administration * Ability to understand and the willingness to sign a written informed consent document. Participants with impaired decision-making capacity who have a legally-authorized representative (LAR) and/or family member available will also be eligible Exclusion Criteria: * Patients who have had chemotherapy must have full recovery of organ and marrow function following the nadir of the last chemotherapy cycle * Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> grade 1) with the exception of alopecia * Patients who are receiving any other investigational agents * Patients who have previously received bevacizumab * History of allergic reactions attributed to compounds of similar chemical or biologic composition to selinexor (KPT-330) or temozolomide * History of hypersensitivity to dacarbazine (DTIC), since both dacarbazine and temozolomide are metabolized to 5-(3-methyltriazen-1-yl)-imidazole-4-carboxamide (MTIC) * Patients with uncontrolled intercurrent illness * Pregnant women are excluded from this study because selinexor (KPT-330) is a selective inhibitor of nuclear export with 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 (KPT-330), breastfeeding is not allowed for mothers during treatment with selinexor (KPT-330) and for 7 days after the last dose. These potential risks may also apply to other agents used in this study * Hospitalized patients with severe coronavirus disease of 2019 (COVID-19) who are \>= 75 years old, or with a high-risk COVID-GRAM score, or with lactate dehydrogenase (LDH) \> 370 (U/L) AND D-Dimer \> 600 mcg/L FEU should not receive low-dose selinexor (KPT-330) pending additional results

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Conditions

The condition(s) this trial relates to.

glioblastoma IDH-wildtype glioblastoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

MGMT-methylated glioblastoma Recurrent glioblastoma, IDH-wildtype Recurrent MGMT-methylated glioblastoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    33 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • City of Hope Comprehensive Cancer Center

    RECRUITING

    Duarte, California, 91010, United States

    Contact Email: •••••@•••••

  • Cooperman Barnabas Medical Center

    RECRUITING

    Livingston, New Jersey, 07039, United States

  • Emory University Hospital Midtown

    RECRUITING

    Atlanta, Georgia, 30308, United States

  • Emory University Hospital/Winship Cancer Institute

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Huntsman Cancer Institute/University of Utah

    SUSPENDED

    Salt Lake City, Utah, 84112, United States

  • Keck Medicine of USC Koreatown

    SUSPENDED

    Los Angeles, California, 90020, United States

  • Laura and Isaac Perlmutter Cancer Center at NYU Langone

    RECRUITING

    New York, New York, 10016, United States

    Contact Email: •••••@•••••

  • Los Angeles General Medical Center

    SUSPENDED

    Los Angeles, California, 90033, United States

  • Mayo Clinic Hospital in Arizona

    RECRUITING

    Phoenix, Arizona, 85054, United States

  • Mayo Clinic in Florida

    RECRUITING

    Jacksonville, Florida, 32224-9980, United States

  • Mayo Clinic in Rochester

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Moffitt Cancer Center

    RECRUITING

    Tampa, Florida, 33612, United States

    Contact Email: •••••@•••••

  • NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center

    RECRUITING

    New York, New York, 10032, United States

    Contact Email: •••••@•••••

  • Ohio State University Comprehensive Cancer Center

    RECRUITING

    Columbus, Ohio, 43210, United States

  • Roswell Park Cancer Institute

    ACTIVE_NOT_RECRUITING

    Buffalo, New York, 14263, United States

  • Rutgers Cancer Institute of New Jersey

    RECRUITING

    New Brunswick, New Jersey, 08903, United States

  • Rutgers New Jersey Medical School

    SUSPENDED

    Newark, New Jersey, 07101, United States

  • UC San Diego Moores Cancer Center

    RECRUITING

    La Jolla, California, 92093, United States

    Contact Email: •••••@•••••

  • UCHealth University of Colorado Hospital

    RECRUITING

    Aurora, Colorado, 80045, United States

  • UM Sylvester Comprehensive Cancer Center at Coral Gables

    RECRUITING

    Coral Gables, Florida, 33146, United States

  • UM Sylvester Comprehensive Cancer Center at Deerfield Beach

    RECRUITING

    Deerfield Beach, Florida, 33442, United States

  • UPMC Hillman Cancer Center

    RECRUITING

    Pittsburgh, Pennsylvania, 15232, United States

  • USC / Norris Comprehensive Cancer Center

    SUSPENDED

    Los Angeles, California, 90033, United States

  • University of California Davis Comprehensive Cancer Center

    RECRUITING

    Sacramento, California, 95817, United States

  • University of Chicago Comprehensive Cancer Center

    RECRUITING

    Chicago, Illinois, 60637, United States

    Contact Email: •••••@•••••

  • University of Chicago Medicine-Orland Park

    RECRUITING

    Orland Park, Illinois, 60462, United States

    Contact Email: •••••@•••••

  • University of Cincinnati Cancer Center-UC Medical Center

    RECRUITING

    Cincinnati, Ohio, 45219, United States

    Contact Email: •••••@•••••

  • University of Cincinnati Cancer Center-West Chester

    RECRUITING

    West Chester, Ohio, 45069, United States

    Contact Email: •••••@•••••

  • University of Kentucky/Markey Cancer Center

    RECRUITING

    Lexington, Kentucky, 40536, United States

  • University of Miami Miller School of Medicine-Sylvester Cancer Center

    RECRUITING

    Miami, Florida, 33136, United States

  • University of Oklahoma Health Sciences Center

    RECRUITING

    Oklahoma City, Oklahoma, 73104, United States

  • University of Virginia Cancer Center

    ACTIVE_NOT_RECRUITING

    Charlottesville, Virginia, 22908, United States

  • University of Wisconsin Carbone Cancer Center - Eastpark Medical Center

    RECRUITING

    Madison, Wisconsin, 53718, United States

    Contact Email: •••••@•••••

  • University of Wisconsin Carbone Cancer Center - University Hospital

    RECRUITING

    Madison, Wisconsin, 53792, United States

    Contact Email: •••••@•••••

  • VCU Massey Comprehensive Cancer Center

    ACTIVE_NOT_RECRUITING

    Richmond, Virginia, 23298, United States

  • Wake Forest University Health Sciences

    RECRUITING

    Winston-Salem, North Carolina, 27157, United States

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