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| ID | Type | Description | Link |
|---|---|---|---|
| 20-C-0027 |
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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.
Background:
Objectives:
-Assess the safety, tolerability, and maximum tolerated dose of selinexor when combined with temozolomide and radiotherapy in patients with newly diagnosed glioblastoma and gliosarcoma.
Eligibility:
Design:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1/Experimental Therapy - Selinexor with Temozolomide and Radiation | Experimental | Selinexor with temozolomide and radiation |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Selinexor | Drug | Selinexor will be administered orally at an initial dose of 80 mg. The first dose will be given on day 2 of radiation and will thereafter be administered weekly on the second day of weekly radiation on weeks 1, 2, 4, and 5. If this dose level is tolerated, the dose will be escalated to 60 mg twice a week (days 1 and 4) on weeks 1,2,4,5. The third and final dose level will also be 60mg administered twice weekly for 6 weeks starting on days 1 and 4 radiation. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose (MTD) of Selinexor | The MTD is the dose level at which no more than 1 of up to 6 participants experience dose limiting-toxicity (DLT) within 1 month of completion of treatment, and the dose below that at which at least 2 (of< =6) participants have DLT as a result of selinexor/radiation therapy (RT)/temozolomide. | 7 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Dose-limiting Toxicities of Selinexor to Concurrent Radiation Therapy and Temozolomide Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) and Radiation Therapy Oncology Group (RTOG) | Dose-limiting toxicities of Selinexor to concurrent radiation therapy and temozolomide. A DLT is defined as a clinically significant adverse event assessed as unrelated to tumor progression, intercurrent illness or concomitant medications and meets any of the criteria such as any Grade 3 or 4 toxicity per Common Terminology Criteria for Adverse Events (CTCAE) v5.0; and any Grade 3 or 4 toxicity per Radiation Therapy Oncology Group (RTOG) acute morbidity. CTCAE: Grade 3 is severe, and Grade 4 is life-threatening. RTOG: Grade 3 Brain/Central nervous system (CNS): neurologic findings present sufficient to require home care; Skin: confluent moist desquamation other than skin folds; Eye: severe keratitis; Ear: severe external otitis; and Grade 4 Brain/CNS is serious neurologic impairment; Skin: ulceration; Eye: loss of vision; and Ear: deafness.DLT's include all adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity. |
| Measure | Description | Time Frame |
|---|---|---|
| Dose-limiting Toxicities (DLT) Effects on Quality of Life (QOL) Using the MD Anderson Symptom Inventory for Brain Tumors (MDSAI-BT) | DLT effects on quality of life (QOL) using the MD Anderson Symptom Inventory for Brain Tumors (MDASI-BT) in the setting of the addition of Selinexor to concurrent radiation therapy and temozolomide. A DLT is defined as a clinically significant adverse event assessed as unrelated to tumor progression, intercurrent illness or concomitant medications and meets any of the criteria such as any Grade 3 or 4 toxicity per Common Terminology Criteria for Adverse Events (CTCAE) v5.0; and any Grade 3 or 4 toxicity per Radiation Therapy Oncology Group (RTOG) acute morbidity. QOL life scores from questionnaires rating symptoms on a scale of 0 (symptoms not present)-10 (as bad as you can imagine) will be summarized. A score of 0 is the best outcome. A score of 10 is the worst outcome. The difference between two timepoints - baseline and close of treatment is also reported. |
INCLUSION CRITERIA:
Histological diagnosis
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.
EXCLUSION CRITERIA:
Patients who are receiving any other investigational agents and have had prior therapy including:
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:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Kevin A Camphausen, M.D. | National Cancer Institute (NCI) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institutes of Health Clinical Center | Bethesda | Maryland | 20892 | United States |
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| Label | URL |
|---|---|
| NIH Clinical Center Detailed Web Page | View source |
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All individual participant data (IPD) recorded in the medical record will be shared with intramural investigators upon request. All collected IPD will be shared with collaborators under the terms of collaborative agreements.
Clinical data available during the study and indefinitely.
Clinical data will be made available via subscription to Biomedical Translational Research Information System (BTRIS) and with the permission of the study principal investigator (PI).
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No participants were enrolled in Dose Level -1.
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| ID | Title | Description |
|---|---|---|
| FG000 | Dose Level -1: Selinexor 80mg on Weeks 1, 4 With Temozolomide & Radiation | Participants with newly diagnosed glioblastoma or gliosarcoma. Selinexor with temozolomide and radiation. Dose Level -1: Selinexor 80mg on Weeks 1, 4 Temozolomide will begin on the first day or evening prior of radiation and be administered orally daily at a dose of 75 mg/m^2 during the radiation treatment. Temozolomide will continue until the completion of radiation and then will be stopped. Beginning 1-month post-radiation therapy (RT), the adjuvant temozolomide will be given per standard of care. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 30, 2025 |
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| Temozolomide | Drug | Temozolomide will begin on the first day or evening prior of radiation and be administered orally daily at a dose of 75 mg/m^2 during the radiation treatment. Temozolomide will continue until the completion of radiation and then will be stopped. Beginning 1-month post-radiation therapy (RT), the adjuvant temozolomide will be given per standard of care. |
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| Generic Radiation therapy (RT) | Radiation | Radiation therapy (RT) will be administered daily (Monday to Friday) |
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| Selective serotonin receptor (5-HT3) antagonists | Other | Anti-emetic for breakthrough nausea. |
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| Olanzapine | Other | 2.5mg to 5mg once a day if weight loss is rapid. |
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| Salt tablets | Dietary Supplement | To treat hyponatremia, add salt tablets to participants diet per institutional guidelines. |
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| Anti-diarrheal | Other | Treat diarrhea with an anti-diarrheal per institutional guidelines |
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| Measured each week of treatment and up to 30 days post treatment; approximately 6-7 weeks with another month added on = ~ 11 weeks to monitor. |
| Dose-limiting Toxicities Effects on Quality of Life (QOL) | Define the dose-limiting toxicities (DLT) effects on quality of life (QOL) in the setting of the addition of Selinexor to concurrent radiation therapy and temozolomide. A DLT is defined as a clinically significant adverse event assessed as unrelated to tumor progression, intercurrent illness or concomitant medications and meets any of the criteria such as any Grade 3 or 4 toxicity per Common Terminology Criteria for Adverse Events (CTCAE) v5.0; and any Grade 3 or 4 toxicity per Radiation Therapy Oncology Group (RTOG) acute morbidity. QOL life scores will be summarized. DLT's include all adverse events (AE), including clinically significant abnormal findings on laboratory evaluations, regardless of severity. Evaluations completed on participants weekly or complications requiring admission to the emergency room (ER)/hospital are also included in the collection of AEs to determine if DLT. | Measured each week of treatment and up to 30 days post treatment; approximately 6-7 weeks with another month added on = ~ 11 weeks to monitor. |
| Dose-limiting Toxicities (DLT) Effects on Neurocognition | Define the dose-limiting toxicities effects on neurocognition in the setting of the addition of Selinexor to concurrent radiation therapy and temozolomide. A DLT is defined as a clinically significant adverse event assessed as unrelated to tumor progression, intercurrent illness or concomitant medications and meets any of the criteria such as any Grade 3 or 4 toxicity per Common Terminology Criteria for Adverse Events (CTCAE) v5.0; and any Grade 3 or 4 toxicity per Radiation Therapy Oncology Group (RTOG) acute morbidity. DLT's include all adverse events (AE), including clinically significant abnormal findings on laboratory evaluations, regardless of severity. Evaluations completed on participants weekly or complications requiring admission to the emergency room (ER)/hospital are also included in the collection of AE's to determine if DLT. | Measured each week of treatment and up to 30 days post treatment; approximately 6-7 weeks with another month added on = ~ 11 weeks to monitor. |
| Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Scale | The PROMIS depression questionnaire in the setting of the addition of Selinexor to concurrent radiation therapy and temozolomide. A DLT is defined as a clinically significant adverse event assessed as unrelated to tumor progression, intercurrent illness or concomitant medications and meets any of the criteria such as any Grade 3 or 4 toxicity per Common Terminology Criteria for Adverse Events (CTCAE) v5.0; and any Grade 3 or 4 toxicity per Radiation Therapy Oncology Group (RTOG) acute morbidity. QOL life scores from questionnaires rating symptoms on a scale of 1 (never) - 5 (very often several times a day) will be summarized. A score of 1 is the best outcome. A score of 5 is worst outcome. The difference between two timepoints - baseline and close of treatment is also reported. | Baseline and completion of treatment, up to 3 years |
| Baseline and close of treatment, up to 3 years |
| Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Scale | The PROMIS anxiety scale in the setting of the addition of Selinexor to concurrent radiation therapy and temozolomide. A DLT is defined as a clinically significant adverse event assessed as unrelated to tumor progression, intercurrent illness or concomitant medications and meets any of the criteria such as any Grade 3 or 4 toxicity per Common Terminology Criteria for Adverse Events (CTCAE) v5.0; and any Grade 3 or 4 toxicity per Radiation Therapy Oncology Group (RTOG) acute morbidity. QOL life scores from questionnaires rating symptoms on a scale of 1 (never) - 5 (always) will be summarized. A score of 1 is the best outcome. A score of 5 is the worst outcome. The difference between two timepoints - baseline and close of treatment is also reported. | Baseline and completion of treatment, up to 3 years |
| National Cancer Institute (NCI) Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) | The NCI PRO-CTCAE in the setting of the addition of Selinexor to concurrent radiation therapy and temozolomide. A DLT is defined as a clinically significant adverse event assessed as unrelated to tumor progression, intercurrent illness or concomitant medications and meets any of the criteria such as any Grade 3 or 4 toxicity per Common Terminology Criteria for Adverse Events (CTCAE) v5.0; and any Grade 3 or 4 toxicity per Radiation Therapy Oncology Group (RTOG) acute morbidity. QOL life scores from questionnaires rating symptoms on a scale of 0 (None) - 4 (Very severe) will be summarized. A score of 0 is the best outcome. A score of 4 is the worst outcome. The difference between two timepoints - baseline and close of treatment is also reported. | Baseline and completion of treatment, up to 3 years |
| Neuro-quality of Life (QOL) Assessment Cognition Function | The Neuro-QOL assessment Cognition Function in the setting of the addition of Selinexor to concurrent radiation therapy and temozolomide. A DLT is defined as a clinically significant adverse event assessed as unrelated to tumor progression, intercurrent illness or concomitant medications and meets any of the criteria such as any Grade 3 or 4 toxicity per Common Terminology Criteria for Adverse Events (CTCAE) v5.0; and any Grade 3 or 4 toxicity per Radiation Therapy Oncology Group (RTOG) acute morbidity. QOL life scores from questionnaires rating symptoms on a scale of 5 (Never) -1 (Very often-several times a day), e.g., thinking slow, will be summarized. A score of 5 is the best outcome. A score of 1 is the worst outcome. The difference between two timepoints - baseline and close of treatment is also reported. | Baseline and completion of treatment, up to 3 years |
| Progression Free Survival (PFS) | PFS is defined as the time from initiation of treatment on protocol to progression as per Response Assessment in Neuro-Oncology (RANO) criteria or death due to disease progression. Progressive disease is at least two sequential scans separated by at ≥4 weeks both exhibiting ≥25% increase in sum of products of perpendicular diameters or ≥40% increase in total volume of enhancing lesions. Clear clinical deterioration not attributable to other causes apart from tumor or attributable to changes in steroid use. Failure to return for evaluation as a result of death or deteriorating condition. | From initiation of treatment on protocol to progression as per RANO criteria or death due to disease progression, approximately months |
| Overall Survival (OS) | OS is defined as the time from initiation of treatment on protocol to date of death due to any cause. For participants alive as of last follow-up, time to death will be censored at last contact date. | From initiation of treatment on protocol to date of death due to any cause, approximately months. |
| Number of Participants With Serious and/or Non-Serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0) | Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event. | Adverse events are documented from the first study intervention, Study Day 1, through 30 days after the subject received the last study drug administration, an average of 2.5 months. |
| FG001 | Dose Level 1: Selinexor 80mg on Weeks 1, 2, 4, 5 With Temozolomide & Radiation | Participants with newly diagnosed glioblastoma or gliosarcoma. Selinexor with temozolomide and radiation. Dose Level 1: Selinexor 80mg on Weeks 1, 2, 4, 5 Temozolomide will begin on the first day or evening prior of radiation and be administered orally daily at a dose of 75 mg/m^2 during the radiation treatment. Temozolomide will continue until the completion of radiation and then will be stopped. Beginning 1-month post-radiation therapy (RT), the adjuvant temozolomide will be given per standard of care. |
| FG002 | Dose Level 2: Selinexor 60mg Twice a Week on Weeks 1, 2, 4, 5 With Temozolomide & Radiation | Participants with newly diagnosed glioblastoma or gliosarcoma. Selinexor with temozolomide and radiation. Dose Level 2: 60mg Twice a Week on Weeks 1, 2, 4, 5 Temozolomide will begin on the first day or evening prior of radiation and be administered orally daily at a dose of 75 mg/m^2 during the radiation treatment. Temozolomide will continue until the completion of radiation and then will be stopped. Beginning 1-month post-radiation therapy (RT), the adjuvant temozolomide will be given per standard of care. |
| FG003 | Dose Level 3: Selinexor 60mg Twice a Week, Weeks 1-6 With Temozolomide & Radiation | Participants with newly diagnosed glioblastoma or gliosarcoma. Selinexor with temozolomide and radiation. Dose Level 3: 60mg Twice a Week, Weeks 1-6 Temozolomide will begin on the first day or evening prior of radiation and be administered orally daily at a dose of 75 mg/m^2 during the radiation treatment. Temozolomide will continue until the completion of radiation and then will be stopped. Beginning 1-month post-radiation therapy (RT), the adjuvant temozolomide will be given per standard of care. |
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| NOT COMPLETED |
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No participants were enrolled in Dose Level -1.
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| ID | Title | Description |
|---|---|---|
| BG000 | Dose Level -1: Selinexor 80mg on Weeks 1, 4 With Temozolomide & Radiation | Participants with newly diagnosed glioblastoma or gliosarcoma. Selinexor with temozolomide and radiation. Dose Level -1: Selinexor 80mg on Weeks 1, 4 Temozolomide will begin on the first day or evening prior of radiation and be administered orally daily at a dose of 75 mg/m^2 during the radiation treatment. Temozolomide will continue until the completion of radiation and then will be stopped. Beginning 1-month post-radiation therapy (RT), the adjuvant temozolomide will be given per standard of care. |
| BG001 | Dose Level 1: Selinexor 80mg on Weeks 1, 2, 4, 5 With Temozolomide & Radiation | Participants with newly diagnosed glioblastoma or gliosarcoma. Selinexor with temozolomide and radiation. Dose Level 1: Selinexor 80mg on Weeks 1, 2, 4, 5 Temozolomide will begin on the first day or evening prior of radiation and be administered orally daily at a dose of 75 mg/m^2 during the radiation treatment. Temozolomide will continue until the completion of radiation and then will be stopped. Beginning 1-month post-radiation therapy (RT), the adjuvant temozolomide will be given per standard of care. |
| BG002 | Dose Level 2: Selinexor 60mg Twice a Week on Weeks 1, 2, 4, 5 With Temozolomide & Radiation | Participants with newly diagnosed glioblastoma or gliosarcoma. Selinexor with temozolomide and radiation. Dose Level 2: 60mg Twice a Week on Weeks 1, 2, 4, 5 Temozolomide will begin on the first day or evening prior of radiation and be administered orally daily at a dose of 75 mg/m^2 during the radiation treatment. Temozolomide will continue until the completion of radiation and then will be stopped. Beginning 1-month post-radiation therapy (RT), the adjuvant temozolomide will be given per standard of care. |
| BG003 | Dose Level 3: Selinexor 60mg Twice a Week, Weeks 1-6 With Temozolomide & Radiation | Participants with newly diagnosed glioblastoma or gliosarcoma. Selinexor with temozolomide and radiation. Dose Level 3: 60mg Twice a Week, Weeks 1-6 Temozolomide will begin on the first day or evening prior of radiation and be administered orally daily at a dose of 75 mg/m^2 during the radiation treatment. Temozolomide will continue until the completion of radiation and then will be stopped. Beginning 1-month post-radiation therapy (RT), the adjuvant temozolomide will be given per standard of care. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
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| Primary | Maximum Tolerated Dose (MTD) of Selinexor | The MTD is the dose level at which no more than 1 of up to 6 participants experience dose limiting-toxicity (DLT) within 1 month of completion of treatment, and the dose below that at which at least 2 (of< =6) participants have DLT as a result of selinexor/radiation therapy (RT)/temozolomide. | Posted | Number | mg/m^2 | 7 weeks |
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| Secondary | Dose-limiting Toxicities of Selinexor to Concurrent Radiation Therapy and Temozolomide Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) and Radiation Therapy Oncology Group (RTOG) | Dose-limiting toxicities of Selinexor to concurrent radiation therapy and temozolomide. A DLT is defined as a clinically significant adverse event assessed as unrelated to tumor progression, intercurrent illness or concomitant medications and meets any of the criteria such as any Grade 3 or 4 toxicity per Common Terminology Criteria for Adverse Events (CTCAE) v5.0; and any Grade 3 or 4 toxicity per Radiation Therapy Oncology Group (RTOG) acute morbidity. CTCAE: Grade 3 is severe, and Grade 4 is life-threatening. RTOG: Grade 3 Brain/Central nervous system (CNS): neurologic findings present sufficient to require home care; Skin: confluent moist desquamation other than skin folds; Eye: severe keratitis; Ear: severe external otitis; and Grade 4 Brain/CNS is serious neurologic impairment; Skin: ulceration; Eye: loss of vision; and Ear: deafness.DLT's include all adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity. | Posted | Number | toxicities | Measured each week of treatment and up to 30 days post treatment; approximately 6-7 weeks with another month added on = ~ 11 weeks to monitor. |
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| Secondary | Dose-limiting Toxicities Effects on Quality of Life (QOL) | Define the dose-limiting toxicities (DLT) effects on quality of life (QOL) in the setting of the addition of Selinexor to concurrent radiation therapy and temozolomide. A DLT is defined as a clinically significant adverse event assessed as unrelated to tumor progression, intercurrent illness or concomitant medications and meets any of the criteria such as any Grade 3 or 4 toxicity per Common Terminology Criteria for Adverse Events (CTCAE) v5.0; and any Grade 3 or 4 toxicity per Radiation Therapy Oncology Group (RTOG) acute morbidity. QOL life scores will be summarized. DLT's include all adverse events (AE), including clinically significant abnormal findings on laboratory evaluations, regardless of severity. Evaluations completed on participants weekly or complications requiring admission to the emergency room (ER)/hospital are also included in the collection of AEs to determine if DLT. | Posted | Number | toxicities | Measured each week of treatment and up to 30 days post treatment; approximately 6-7 weeks with another month added on = ~ 11 weeks to monitor. |
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| Secondary | Dose-limiting Toxicities (DLT) Effects on Neurocognition | Define the dose-limiting toxicities effects on neurocognition in the setting of the addition of Selinexor to concurrent radiation therapy and temozolomide. A DLT is defined as a clinically significant adverse event assessed as unrelated to tumor progression, intercurrent illness or concomitant medications and meets any of the criteria such as any Grade 3 or 4 toxicity per Common Terminology Criteria for Adverse Events (CTCAE) v5.0; and any Grade 3 or 4 toxicity per Radiation Therapy Oncology Group (RTOG) acute morbidity. DLT's include all adverse events (AE), including clinically significant abnormal findings on laboratory evaluations, regardless of severity. Evaluations completed on participants weekly or complications requiring admission to the emergency room (ER)/hospital are also included in the collection of AE's to determine if DLT. | Posted | Number | toxicities | Measured each week of treatment and up to 30 days post treatment; approximately 6-7 weeks with another month added on = ~ 11 weeks to monitor. |
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| Secondary | Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Scale | The PROMIS depression questionnaire in the setting of the addition of Selinexor to concurrent radiation therapy and temozolomide. A DLT is defined as a clinically significant adverse event assessed as unrelated to tumor progression, intercurrent illness or concomitant medications and meets any of the criteria such as any Grade 3 or 4 toxicity per Common Terminology Criteria for Adverse Events (CTCAE) v5.0; and any Grade 3 or 4 toxicity per Radiation Therapy Oncology Group (RTOG) acute morbidity. QOL life scores from questionnaires rating symptoms on a scale of 1 (never) - 5 (very often several times a day) will be summarized. A score of 1 is the best outcome. A score of 5 is worst outcome. The difference between two timepoints - baseline and close of treatment is also reported. | Posted | Median | Full Range | Score on a scale | Baseline and completion of treatment, up to 3 years |
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| Other Pre-specified | Dose-limiting Toxicities (DLT) Effects on Quality of Life (QOL) Using the MD Anderson Symptom Inventory for Brain Tumors (MDSAI-BT) | DLT effects on quality of life (QOL) using the MD Anderson Symptom Inventory for Brain Tumors (MDASI-BT) in the setting of the addition of Selinexor to concurrent radiation therapy and temozolomide. A DLT is defined as a clinically significant adverse event assessed as unrelated to tumor progression, intercurrent illness or concomitant medications and meets any of the criteria such as any Grade 3 or 4 toxicity per Common Terminology Criteria for Adverse Events (CTCAE) v5.0; and any Grade 3 or 4 toxicity per Radiation Therapy Oncology Group (RTOG) acute morbidity. QOL life scores from questionnaires rating symptoms on a scale of 0 (symptoms not present)-10 (as bad as you can imagine) will be summarized. A score of 0 is the best outcome. A score of 10 is the worst outcome. The difference between two timepoints - baseline and close of treatment is also reported. | Posted | Median | Full Range | Scores on a scale | Baseline and close of treatment, up to 3 years |
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| Other Pre-specified | Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Scale | The PROMIS anxiety scale in the setting of the addition of Selinexor to concurrent radiation therapy and temozolomide. A DLT is defined as a clinically significant adverse event assessed as unrelated to tumor progression, intercurrent illness or concomitant medications and meets any of the criteria such as any Grade 3 or 4 toxicity per Common Terminology Criteria for Adverse Events (CTCAE) v5.0; and any Grade 3 or 4 toxicity per Radiation Therapy Oncology Group (RTOG) acute morbidity. QOL life scores from questionnaires rating symptoms on a scale of 1 (never) - 5 (always) will be summarized. A score of 1 is the best outcome. A score of 5 is the worst outcome. The difference between two timepoints - baseline and close of treatment is also reported. | Posted | Median | Full Range | Score on a scale | Baseline and completion of treatment, up to 3 years |
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| Other Pre-specified | National Cancer Institute (NCI) Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) | The NCI PRO-CTCAE in the setting of the addition of Selinexor to concurrent radiation therapy and temozolomide. A DLT is defined as a clinically significant adverse event assessed as unrelated to tumor progression, intercurrent illness or concomitant medications and meets any of the criteria such as any Grade 3 or 4 toxicity per Common Terminology Criteria for Adverse Events (CTCAE) v5.0; and any Grade 3 or 4 toxicity per Radiation Therapy Oncology Group (RTOG) acute morbidity. QOL life scores from questionnaires rating symptoms on a scale of 0 (None) - 4 (Very severe) will be summarized. A score of 0 is the best outcome. A score of 4 is the worst outcome. The difference between two timepoints - baseline and close of treatment is also reported. | Posted | Median | Full Range | Scores on a scale | Baseline and completion of treatment, up to 3 years |
| ||||||||||||||||||||||||||||
| Other Pre-specified | Neuro-quality of Life (QOL) Assessment Cognition Function | The Neuro-QOL assessment Cognition Function in the setting of the addition of Selinexor to concurrent radiation therapy and temozolomide. A DLT is defined as a clinically significant adverse event assessed as unrelated to tumor progression, intercurrent illness or concomitant medications and meets any of the criteria such as any Grade 3 or 4 toxicity per Common Terminology Criteria for Adverse Events (CTCAE) v5.0; and any Grade 3 or 4 toxicity per Radiation Therapy Oncology Group (RTOG) acute morbidity. QOL life scores from questionnaires rating symptoms on a scale of 5 (Never) -1 (Very often-several times a day), e.g., thinking slow, will be summarized. A score of 5 is the best outcome. A score of 1 is the worst outcome. The difference between two timepoints - baseline and close of treatment is also reported. | Posted | Median | Full Range | Score on a scale | Baseline and completion of treatment, up to 3 years |
| ||||||||||||||||||||||||||||
| Other Pre-specified | Progression Free Survival (PFS) | PFS is defined as the time from initiation of treatment on protocol to progression as per Response Assessment in Neuro-Oncology (RANO) criteria or death due to disease progression. Progressive disease is at least two sequential scans separated by at ≥4 weeks both exhibiting ≥25% increase in sum of products of perpendicular diameters or ≥40% increase in total volume of enhancing lesions. Clear clinical deterioration not attributable to other causes apart from tumor or attributable to changes in steroid use. Failure to return for evaluation as a result of death or deteriorating condition. | Not Posted | Jul 2028 | From initiation of treatment on protocol to progression as per RANO criteria or death due to disease progression, approximately months | Participants | ||||||||||||||||||||||||||||||
| Other Pre-specified | Overall Survival (OS) | OS is defined as the time from initiation of treatment on protocol to date of death due to any cause. For participants alive as of last follow-up, time to death will be censored at last contact date. | Not Posted | Jul 2028 | From initiation of treatment on protocol to date of death due to any cause, approximately months. | Participants | ||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants With Serious and/or Non-Serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0) | Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event. | Posted | Count of Participants | Participants | Adverse events are documented from the first study intervention, Study Day 1, through 30 days after the subject received the last study drug administration, an average of 2.5 months. |
|
Adverse events are documented from the first study intervention, Study Day 1, through 30 days after the subject received the last study drug administration, an average of 2.5 months.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dose Level 1: Selinexor 80mg on Weeks 1, 2, 4, 5 With Temozolomide & Radiation | Participants with newly diagnosed glioblastoma or gliosarcoma. Selinexor with temozolomide and radiation. Dose Level 1: Selinexor 80mg on Weeks 1, 2, 4, 5 Temozolomide will begin on the first day or evening prior of radiation and be administered orally daily at a dose of 75 mg/m^2 during the radiation treatment. Temozolomide will continue until the completion of radiation and then will be stopped. Beginning 1-month post-radiation therapy (RT), the adjuvant temozolomide will be given per standard of care. | 1 | 3 | 2 | 3 | 3 | 3 |
| EG001 | Dose Level 2: Selinexor 60mg Twice a Week on Weeks 1, 2, 4, 5 With Temozolomide & Radiation | Participants with newly diagnosed glioblastoma or gliosarcoma. Selinexor with temozolomide and radiation. Dose Level 2: 60mg Twice a Week on Weeks 1, 2, 4, 5 Temozolomide will begin on the first day or evening prior of radiation and be administered orally daily at a dose of 75 mg/m^2 during the radiation treatment. Temozolomide will continue until the completion of radiation and then will be stopped. Beginning 1-month post-radiation therapy (RT), the adjuvant temozolomide will be given per standard of care. | 5 | 6 | 2 | 6 | 6 | 6 |
| EG002 | Dose Level 3: Selinexor 60mg Twice a Week, Weeks 1-6 With Temozolomide & Radiation | Participants with newly diagnosed glioblastoma or gliosarcoma. Selinexor with temozolomide and radiation. Dose Level 3: 60mg Twice a Week, Weeks 1-6 Temozolomide will begin on the first day or evening prior of radiation and be administered orally daily at a dose of 75 mg/m^2 during the radiation treatment. Temozolomide will continue until the completion of radiation and then will be stopped. Beginning 1-month post-radiation therapy (RT), the adjuvant temozolomide will be given per standard of care. | 0 | 2 | 0 | 2 | 2 | 2 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anxiety | Psychiatric disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | CTCAE (5.0) | Systematic Assessment |
| |
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Infections and infestations - Other, COVID-19 | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
| |
| Muscle weakness lower limb | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Muscle weakness upper limb | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Seizure | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Akathisia | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Amnesia | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Anxiety | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Blurred vision | Eye disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Concentration impairment | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Confusion | Psychiatric disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Creatinine increased | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Cushingoid | Endocrine disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Dermatitis radiation | Injury, poisoning and procedural complications | CTCAE (5.0) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Dysesthesia | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Dysphasia | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Edema face | General disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Edema limbs | General disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Eosinophilia | Blood and lymphatic system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | CTCAE (5.0) | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Fracture | Injury, poisoning and procedural complications | CTCAE (5.0) | Systematic Assessment |
| |
| Gait disturbance | General disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hypermagnesemia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hypernatremia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hyperphosphatemia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hyperuricemia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Infections and infestations - Other, COVID-19 | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Lipase increased | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Lymphocyte count increased | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Memory impairment | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Muscle weakness left-sided | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Muscle weakness upper limb | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Platelet count decreased | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Seizure | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Serum amylase increased | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Skin ulceration | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | CTCAE (5.0) | Systematic Assessment |
| |
| Thrush | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
| |
| Vascular disorders - Other, DVT | Vascular disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Weight gain | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Weight loss | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| White blood cell decreased | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Wound complication | Injury, poisoning and procedural complications | CTCAE (5.0) | Systematic Assessment |
| |
| Wound infection | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kevin A. Camphausen | National Cancer Institute | 240-760-6205 | camphauk@mail.nih.gov |
| Jan 13, 2026 |
| Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 22, 2023 | Sep 12, 2024 | ICF_001.pdf |
| ID | Term |
|---|---|
| D018316 | Gliosarcoma |
| D005909 | Glioblastoma |
| ID | Term |
|---|---|
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D001254 | Astrocytoma |
Not provided
Not provided
| ID | Term |
|---|---|
| C585161 | selinexor |
| D000077204 | Temozolomide |
| D012702 | Serotonin Antagonists |
| D000077152 | Olanzapine |
| D012492 | Salts |
| D012965 | Sodium Chloride |
| D008139 | Loperamide |
| ID | Term |
|---|---|
| D003606 | Dacarbazine |
| D014226 | Triazenes |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D018490 | Serotonin Agents |
| D018377 | Neurotransmitter Agents |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D045505 | Physiological Effects of Drugs |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D007287 | Inorganic Chemicals |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D017670 | Sodium Compounds |
| D010880 | Piperidines |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG001 | Dose Level 2: Selinexor 60mg Twice a Week on Weeks 1, 2, 4, 5 With Temozolomide & Radiation | Participants with newly diagnosed glioblastoma or gliosarcoma. Selinexor with temozolomide and radiation. Dose Level 2: 60mg Twice a Week on Weeks 1, 2, 4, 5 Temozolomide will begin on the first day or evening prior of radiation and be administered orally daily at a dose of 75 mg/m^2 during the radiation treatment. Temozolomide will continue until the completion of radiation and then will be stopped. Beginning 1-month post-radiation therapy (RT), the adjuvant temozolomide will be given per standard of care. |
| OG002 | Dose Level 3: Selinexor 60mg Twice a Week, Weeks 1-6 With Temozolomide & Radiation | Participants with newly diagnosed glioblastoma or gliosarcoma. Selinexor with temozolomide and radiation. Dose Level 3: 60mg Twice a Week, Weeks 1-6 Temozolomide will begin on the first day or evening prior of radiation and be administered orally daily at a dose of 75 mg/m^2 during the radiation treatment. Temozolomide will continue until the completion of radiation and then will be stopped. Beginning 1-month post-radiation therapy (RT), the adjuvant temozolomide will be given per standard of care. |
|
|
| OG001 | Dose Level 2: Selinexor 60mg Twice a Week on Weeks 1, 2, 4, 5 With Temozolomide & Radiation | Participants with newly diagnosed glioblastoma or gliosarcoma. Selinexor with temozolomide and radiation. Dose Level 2: 60mg Twice a Week on Weeks 1, 2, 4, 5 Temozolomide will begin on the first day or evening prior of radiation and be administered orally daily at a dose of 75 mg/m^2 during the radiation treatment. Temozolomide will continue until the completion of radiation and then will be stopped. Beginning 1-month post-radiation therapy (RT), the adjuvant temozolomide will be given per standard of care. |
| OG002 | Dose Level 3: Selinexor 60mg Twice a Week, Weeks 1-6 With Temozolomide & Radiation | Participants with newly diagnosed glioblastoma or gliosarcoma. Selinexor with temozolomide and radiation. Dose Level 3: 60mg Twice a Week, Weeks 1-6 Temozolomide will begin on the first day or evening prior of radiation and be administered orally daily at a dose of 75 mg/m^2 during the radiation treatment. Temozolomide will continue until the completion of radiation and then will be stopped. Beginning 1-month post-radiation therapy (RT), the adjuvant temozolomide will be given per standard of care. |
|
|
| OG001 |
| Dose Level 2: Selinexor 60mg Twice a Week on Weeks 1, 2, 4, 5 With Temozolomide & Radiation |
Participants with newly diagnosed glioblastoma or gliosarcoma. Selinexor with temozolomide and radiation. Dose Level 2: 60mg Twice a Week on Weeks 1, 2, 4, 5 Temozolomide will begin on the first day or evening prior of radiation and be administered orally daily at a dose of 75 mg/m^2 during the radiation treatment. Temozolomide will continue until the completion of radiation and then will be stopped. Beginning 1-month post-radiation therapy (RT), the adjuvant temozolomide will be given per standard of care. |
| OG002 | Dose Level 3: Selinexor 60mg Twice a Week, Weeks 1-6 With Temozolomide & Radiation | Participants with newly diagnosed glioblastoma or gliosarcoma. Selinexor with temozolomide and radiation. Dose Level 3: 60mg Twice a Week, Weeks 1-6 Temozolomide will begin on the first day or evening prior of radiation and be administered orally daily at a dose of 75 mg/m^2 during the radiation treatment. Temozolomide will continue until the completion of radiation and then will be stopped. Beginning 1-month post-radiation therapy (RT), the adjuvant temozolomide will be given per standard of care. |
|
|
Participants with newly diagnosed glioblastoma or gliosarcoma. Selinexor with temozolomide and radiation. Dose Level 2: 60mg Twice a Week on Weeks 1, 2, 4, 5 Temozolomide will begin on the first day or evening prior of radiation and be administered orally daily at a dose of 75 mg/m^2 during the radiation treatment. Temozolomide will continue until the completion of radiation and then will be stopped. Beginning 1-month post-radiation therapy (RT), the adjuvant temozolomide will be given per standard of care. |
| OG002 | Dose Level 3: Selinexor 60mg Twice a Week, Weeks 1-6 With Temozolomide & Radiation | Participants with newly diagnosed glioblastoma or gliosarcoma. Selinexor with temozolomide and radiation. Dose Level 3: 60mg Twice a Week, Weeks 1-6 Temozolomide will begin on the first day or evening prior of radiation and be administered orally daily at a dose of 75 mg/m^2 during the radiation treatment. Temozolomide will continue until the completion of radiation and then will be stopped. Beginning 1-month post-radiation therapy (RT), the adjuvant temozolomide will be given per standard of care. |
|
|
|
| OG001 | Dose Level 2: Selinexor 60mg Twice a Week on Weeks 1, 2, 4, 5 With Temozolomide & Radiation | Participants with newly diagnosed glioblastoma or gliosarcoma. Selinexor with temozolomide and radiation. Dose Level 2: 60mg Twice a Week on Weeks 1, 2, 4, 5 Temozolomide will begin on the first day or evening prior of radiation and be administered orally daily at a dose of 75 mg/m^2 during the radiation treatment. Temozolomide will continue until the completion of radiation and then will be stopped. Beginning 1-month post-radiation therapy (RT), the adjuvant temozolomide will be given per standard of care. |
| OG002 | Dose Level 3: Selinexor 60mg Twice a Week, Weeks 1-6 With Temozolomide & Radiation | Participants with newly diagnosed glioblastoma or gliosarcoma. Selinexor with temozolomide and radiation. Dose Level 3: 60mg Twice a Week, Weeks 1-6 Temozolomide will begin on the first day or evening prior of radiation and be administered orally daily at a dose of 75 mg/m^2 during the radiation treatment. Temozolomide will continue until the completion of radiation and then will be stopped. Beginning 1-month post-radiation therapy (RT), the adjuvant temozolomide will be given per standard of care. |
|
|
Participants with newly diagnosed glioblastoma or gliosarcoma. Selinexor with temozolomide and radiation. Dose Level 2: 60mg Twice a Week on Weeks 1, 2, 4, 5 Temozolomide will begin on the first day or evening prior of radiation and be administered orally daily at a dose of 75 mg/m^2 during the radiation treatment. Temozolomide will continue until the completion of radiation and then will be stopped. Beginning 1-month post-radiation therapy (RT), the adjuvant temozolomide will be given per standard of care. |
| OG002 | Dose Level 3: Selinexor 60mg Twice a Week, Weeks 1-6 With Temozolomide & Radiation | Participants with newly diagnosed glioblastoma or gliosarcoma. Selinexor with temozolomide and radiation. Dose Level 3: 60mg Twice a Week, Weeks 1-6 Temozolomide will begin on the first day or evening prior of radiation and be administered orally daily at a dose of 75 mg/m^2 during the radiation treatment. Temozolomide will continue until the completion of radiation and then will be stopped. Beginning 1-month post-radiation therapy (RT), the adjuvant temozolomide will be given per standard of care. |
|
|
|
Participants with newly diagnosed glioblastoma or gliosarcoma. Selinexor with temozolomide and radiation. Dose Level 2: 60mg Twice a Week on Weeks 1, 2, 4, 5 Temozolomide will begin on the first day or evening prior of radiation and be administered orally daily at a dose of 75 mg/m^2 during the radiation treatment. Temozolomide will continue until the completion of radiation and then will be stopped. Beginning 1-month post-radiation therapy (RT), the adjuvant temozolomide will be given per standard of care. |
| OG002 | Dose Level 3: Selinexor 60mg Twice a Week, Weeks 1-6 With Temozolomide & Radiation | Participants with newly diagnosed glioblastoma or gliosarcoma. Selinexor with temozolomide and radiation. Dose Level 3: 60mg Twice a Week, Weeks 1-6 Temozolomide will begin on the first day or evening prior of radiation and be administered orally daily at a dose of 75 mg/m^2 during the radiation treatment. Temozolomide will continue until the completion of radiation and then will be stopped. Beginning 1-month post-radiation therapy (RT), the adjuvant temozolomide will be given per standard of care. |
|
|
Participants with newly diagnosed glioblastoma or gliosarcoma. Selinexor with temozolomide and radiation. Dose Level 2: 60mg Twice a Week on Weeks 1, 2, 4, 5 Temozolomide will begin on the first day or evening prior of radiation and be administered orally daily at a dose of 75 mg/m^2 during the radiation treatment. Temozolomide will continue until the completion of radiation and then will be stopped. Beginning 1-month post-radiation therapy (RT), the adjuvant temozolomide will be given per standard of care. |
| OG002 | Dose Level 3: Selinexor 60mg Twice a Week, Weeks 1-6 With Temozolomide & Radiation | Participants with newly diagnosed glioblastoma or gliosarcoma. Selinexor with temozolomide and radiation. Dose Level 3: 60mg Twice a Week, Weeks 1-6 Temozolomide will begin on the first day or evening prior of radiation and be administered orally daily at a dose of 75 mg/m^2 during the radiation treatment. Temozolomide will continue until the completion of radiation and then will be stopped. Beginning 1-month post-radiation therapy (RT), the adjuvant temozolomide will be given per standard of care. |
|
|
| OG001 | Dose Level 2: Selinexor 60mg Twice a Week on Weeks 1, 2, 4, 5 With Temozolomide & Radiation | Participants with newly diagnosed glioblastoma or gliosarcoma. Selinexor with temozolomide and radiation. Dose Level 2: 60mg Twice a Week on Weeks 1, 2, 4, 5 Temozolomide will begin on the first day or evening prior of radiation and be administered orally daily at a dose of 75 mg/m^2 during the radiation treatment. Temozolomide will continue until the completion of radiation and then will be stopped. Beginning 1-month post-radiation therapy (RT), the adjuvant temozolomide will be given per standard of care. |
| OG002 | Dose Level 3: Selinexor 60mg Twice a Week, Weeks 1-6 With Temozolomide & Radiation | Participants with newly diagnosed glioblastoma or gliosarcoma. Selinexor with temozolomide and radiation. Dose Level 3: 60mg Twice a Week, Weeks 1-6 Temozolomide will begin on the first day or evening prior of radiation and be administered orally daily at a dose of 75 mg/m^2 during the radiation treatment. Temozolomide will continue until the completion of radiation and then will be stopped. Beginning 1-month post-radiation therapy (RT), the adjuvant temozolomide will be given per standard of care. |
|
|