NCT04216329CompletedPhase 1

Selinexor (KPT-330) in Combination With Temozolomide and Radiation Therapy in Patients With Newly Diagnosed Glioblastoma

A Phase I Clinical Trial of Selinexor (KPT-330) in Combination With Temozolomide and Radiation Therapy in Patients With Newly Diagnosed Glioblastoma

Source: ClinicalTrials.gov · Last updated 27 Oct 2026

Brief summary (registry, in English)

Background: Glioblastoma is a type of brain cancer. Treatments include radiation, chemotherapy, and surgery. But survival rates are poor. Researchers think that the drug selinexor, when combined with chemotherapy and radiation, might help. Objective: To learn the highest dose of selinexor that people with brain cancer can tolerate when given with temozolomide and radiation therapy. Eligibility: People ages 18 and older with brain cancer that has not been treated with chemotherapy or radiation. Design: Participants will be screened under another protocol. Before participants start treatment, they will have tests: Neurological and physical evaluations Blood and urine tests Possible computed tomography (CT) scan or magnetic resonance imaging (MRI) of the brain if they have not had one in 3 weeks. Participants will lie in a machine that takes pictures of the body. They may have a dye injected into a vein. Surveys about their well-being Participants will have radiation to the brain for up to 6 weeks. This will usually be given once a day, Monday through Friday. Starting the second day of radiation, participants will take selinexor by mouth once a week. They will take it in weeks 1, 2, 4, and 5. The timing may be changed. Starting the first day of radiation, participants will take temozolomide by mouth once a day until they complete radiation. Participants will have blood tests once per week during treatment. Participants will have a follow-up visit 1 month after they complete treatment. Then they will have visits at least every 2 months for the first 2 years, then at least every 3 months for another year. Visits will include MRIs and blood tests.

Status (registry): Completed
Phase (registry): Phase 1
Study type: Interventional
Enrollment: 11 (actual)
First submitted: 31 Dec 2019
Start date: 7 Jul 2020
Primary completion date: 29 Sept 2023
Lead sponsor: National Cancer Institute (NCI)
Diseases: Glioblastoma
NCT number: NCT04216329

What you commit to

Study type: Interventional · Phase 1
Participants enrolled: 11
From 7 Jul 2020 to the primary completion date, 29 Sept 2023
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

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.
- 3 Patients with coagulation problems and medically significant bleeding in the month prior to start of treatment (peptic ulcers, epistaxis, spontaneous bleeding). Prior history of deep vein thrombosis (DVT) or pulmonary embolism (PE) is not exclusionary.
- 4\. Patients with active uncontrolled or suspected infections
- 5\. Patients with severe liver dysfunction defined as:

Lab values

Total bilirubin \> 1.5 x upper limit of normal (ULN) Note: Subjects with Gilberts syndrome should not be excluded as long as total bilirubin is \< 3.0 x ULN and documentation to support diagnosis is available.
Serum glutamate pyruvate transaminase (SGPT) or called as Alanine aminotransferase (ALT) greater than or equal to 3 x ULN = 135 U/L; for the purpose of this study, the ULN for SGPT is 45 U/L
Serum glutamic oxaloacetic transaminase (SGOT) or called as Aspartate aminotransferase (AST) greater than or equal to 3 x ULN = 150 U/L; for the purpose of this study, the ULN for SGOT is 50 U/L
Serum albumin greater than or equal to 2 x ULN
- 6\. Known active hepatitis A, B, or C infection
- 7\. Human immunodeficiency virus (HIV) patients are not eligible because of their immunocompromised status and overlap of side effects between highly active antiretroviral therapy (HAART) and radiation therapy.
- 8 Patients must not have significantly diseased or obstructed gastrointestinal tract malabsorption, uncontrolled vomiting or diarrhea, or inability to swallow oral medication.
- 9\. 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.
- 10\. Patients with pre-existing known or suspected radiation sensitivity syndromes will be excluded due to potential confounding effect on outcome.

Other

Criteria the registry did not label

INCLUSION CRITERIA:
- Histological diagnosis
- Pathologically confirmed glioblastoma or gliosarcoma (including astrocytoma, grade IV)
- Patients must be eligible for definitive external beam radiotherapy and temozolomide.
- Age \>18 years. Because no dosing or adverse event data are currently available on the use of Selinexor in combination with Temodar in patients \<18 years of age, children are excluded from this study.
- Patients should have a Karnofsky performance scale (KPS) greater than or equal to 70
- Absolute neutrophil count (ANC) \>1.5x10\^9/L; platelet count \>100x10\^9/L; and hemoglobin (Hb) \>9.0 g/dL. Note: the use of transfusion or other intervention prior to cycle 1 day 1 to achieve Hb \>9.0 g/dL is acceptable.
- Ability of subject or Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent document.
- The effects of Selinexor on the developing human fetus are unknown. For this reason and because Selinexor agents as well as other therapeutic agents used in this trial 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, for the duration of study treatment and for one month after treatment. 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.
- Patients must have had surgery and/or biopsy not greater than 8 weeks prior to initial evaluation to be eligible for this study.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
National Institutes of Health Clinical Center Coordinator of this site? Confirm its status	Bethesda	United States	Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.