TriangleNCT02323880 · STUDY IN CONTEXT
Selinexor in Treating Younger Patients With Recurrent or Refractory Solid Tumors or High-Grade Gliomas
Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
Read the full study record and all posted results →
Linked outcomes
The number of toxicity evaluable patients experiencing a dose limiting toxicity at least possibly attributable to selinexor by study part, schema, and dose level.
The number of patients experiencing adverse events at least possibly attributable to selinexor by study part, schema, and dose level.
The median (min, max) of the area under the drug concentration curve evaluated at 0.5, 1, 2, 3, 4, 6, 8, and 24 hours post dose on day 1 for Selinexor by study part, schema, and dose level.
Number of patients with best response using RECIST 1.1 criteria of partial response (at least a 30% decrease in the sum of the diameters of target lesions) or complete response (disappearance of all target and non-target lesions and any pathological lymph nodes must have reduction in short axis to \<10 mm).
Median (min,max) ratio of XPO1 mRNA expression after treatment to pre-treatment by study part, schema, and dose
Median (min,max) ratio of XPO1 mRNA expression after treatment to pre-treatment by study part, schema, and dose
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-recurrent-childhood-glioblastoma
- nct id
- NCT02323880
- trial label
- Selinexor in Treating Younger Patients With Recurrent or Refractory Solid Tumors or High-Grade Gliomas
- applicability
- narrower
- applicability note
- Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- registry-condition-search
- discovery note
- Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
- outcome Count
- 6
- harms Count
- 8
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-recurrent-childhood-glioblastoma
- nct id
- NCT02323880
- outcome key
- om-0000
- source section id
- NCT02323880-om-0000
- source outcome index
- 0
- endpoint
- Number of Dose Limiting Toxicities of Selinexor
- endpoint definition
- The number of toxicity evaluable patients experiencing a dose limiting toxicity at least possibly attributable to selinexor by study part, schema, and dose level.
- time origin
- Up to 28 days
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Toxicity evaluable patients
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-recurrent-childhood-glioblastoma
- nct id
- NCT02323880
- outcome key
- om-0001
- source section id
- NCT02323880-om-0001
- source outcome index
- 1
- endpoint
- Number of Adverse Events of Selinexor
- endpoint definition
- The number of patients experiencing adverse events at least possibly attributable to selinexor by study part, schema, and dose level.
- time origin
- Up to 6 years 11 months
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Toxicity evaluable patients
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-recurrent-childhood-glioblastoma
- nct id
- NCT02323880
- outcome key
- om-0002
- source section id
- NCT02323880-om-0002
- source outcome index
- 2
- endpoint
- Area Under the Drug Concentration Curve of Selinexor
- endpoint definition
- The median (min, max) of the area under the drug concentration curve evaluated at 0.5, 1, 2, 3, 4, 6, 8, and 24 hours post dose on day 1 for Selinexor by study part, schema, and dose level.
- time origin
- Up to 2 days
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All eligible patients
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-recurrent-childhood-glioblastoma
- nct id
- NCT02323880
- outcome key
- om-0003
- source section id
- NCT02323880-om-0003
- source outcome index
- 3
- endpoint
- Antitumor Effect of Selinexor
- endpoint definition
- Number of patients with best response using RECIST 1.1 criteria of partial response (at least a 30% decrease in the sum of the diameters of target lesions) or complete response (disappearance of all target and non-target lesions and any pathological lymph nodes must have reduction in short axis to \<10 mm).
- time origin
- Up to 6 years 11 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Responsive patients
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-recurrent-childhood-glioblastoma
- nct id
- NCT02323880
- outcome key
- om-0004
- source section id
- NCT02323880-om-0004
- source outcome index
- 4
- endpoint
- Pharmacodynamics of Selinexor
- endpoint definition
- Median (min,max) ratio of XPO1 mRNA expression after treatment to pre-treatment by study part, schema, and dose
- time origin
- Up to 28 days
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- There were 0 (zero) patients from Part A: Dose Level 1 (Pre-amendment #1). Participation in the PD studies was optional. The subjects who had matched pre- and post-treatment blood samples were analyzed; not all the subjects had samples collected for PD analysis.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-recurrent-childhood-glioblastoma
- nct id
- NCT02323880
- outcome key
- om-0005
- source section id
- NCT02323880-om-0005
- source outcome index
- 5
- endpoint
- Pharmacodynamics of Selinexor in High-grade Glioma (HGG) Patients
- endpoint definition
- Median (min,max) ratio of XPO1 mRNA expression after treatment to pre-treatment by study part, schema, and dose
- time origin
- Up to 28 days
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- high-grade glioma (HGG) patients with data available
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-recurrent-childhood-glioblastoma
- nct id
- NCT02323880
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Part A: Dose Level 1
- regimen
- 35 mg/m\^2 of Selinexor PO twice weekly on a days 1 and 3 schedule (Mon/Wed, Tues/Thurs, or Wed/Fri) of a 28 day, or 8 dose course (Pre-amendment #1)
- analyzed count
- 6
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02323880-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-recurrent-childhood-glioblastoma
- nct id
- NCT02323880
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Part A: Dose Level 1 (DL 1)
- regimen
- 35 mg/m\^2 of Selinexor PO twice weekly on a days 1 and 3 schedule (Mon/Wed, Tues/Thurs, or Wed/Fri) on Weeks 1-3, Week 4 rest, on a 28 day course (Amendment 1)
- analyzed count
- 12
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02323880-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-recurrent-childhood-glioblastoma
- nct id
- NCT02323880
- outcome key
- om-0000
- arm key
- OG002
- arm label
- Part A: Dose Level -1 (DL -1)
- regimen
- 20 mg/m\^2 of Selinexor PO twice weekly on a days 1 and 3 schedule (Mon/Wed, Tues/Thurs, or Wed/Fri) on Weeks 1-3, Week 4 rest, on a 28 day course
- analyzed count
- 6
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02323880-om-0000#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-recurrent-childhood-glioblastoma
- nct id
- NCT02323880
- outcome key
- om-0000
- arm key
- OG003
- arm label
- Part A: Weekly Dose Level 1 (WDL 1)
- regimen
- 45 mg/m\^2 Selinexor once weekly, on days 1, 8, 15, and 22 of a 28-day cycle
- analyzed count
- 6
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02323880-om-0000#groups/OG003
- release id
- clinical-indications-draft-1
- disease state id
- ds-recurrent-childhood-glioblastoma
- nct id
- NCT02323880
- outcome key
- om-0000
- arm key
- OG004
- arm label
- Part A: Weekly Dose Level -1 (WDL -1)
- regimen
- 35 mg/m2 Selinexor once weekly, on days 1, 8, 15, and 22 of a 28-day cycle
- analyzed count
- 6
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02323880-om-0000#groups/OG004
- release id
- clinical-indications-draft-1
- disease state id
- ds-recurrent-childhood-glioblastoma
- nct id
- NCT02323880
- outcome key
- om-0000
- arm key
- OG005
- arm label
- Part B: Weekly Dose Level -1 (WDL -1)
- regimen
- 35 mg/m\^2 Selinexor once weekly, on days 1, 8, 15, and 22 of a 28-day cycle
- analyzed count
- 7
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02323880-om-0000#groups/OG005
- release id
- clinical-indications-draft-1
- disease state id
- ds-recurrent-childhood-glioblastoma
- nct id
- NCT02323880
- outcome key
- om-0000
- arm key
- OG006
- arm label
- Part PK: Dose Level -1 (DL -1)
- regimen
- 20 mg/m2 of Selinexor PO twice weekly on a days 1 and 3 schedule (Mon/Wed, Tues/Thurs, or Wed/Fri) on Weeks 1-3, Week 4 rest, on a 28 day course
- analyzed count
- 6
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02323880-om-0000#groups/OG006
- release id
- clinical-indications-draft-1
- disease state id
- ds-recurrent-childhood-glioblastoma
- nct id
- NCT02323880
- outcome key
- om-0000
- arm key
- OG007
- arm label
- Part PK: Weekly Dose Level -1 (WDL -1)
- regimen
- 35 mg/m\^2 Selinexor once weekly, on days 1, 8, 15, and 22 of a 28-day cycle
- analyzed count
- 6
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02323880-om-0000#groups/OG007
- release id
- clinical-indications-draft-1
- disease state id
- ds-recurrent-childhood-glioblastoma
- nct id
- NCT02323880
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Part A: Dose Level 1
- regimen
- 35 mg/m\^2 of Selinexor PO twice weekly on a days 1 and 3 schedule (Mon/Wed, Tues/Thurs, or Wed/Fri) of a 28 day, or 8 dose course (Pre-amendment #1)
- analyzed count
- 6
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02323880-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-recurrent-childhood-glioblastoma
- nct id
- NCT02323880
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Part A: Dose Level 1 (DL 1)
- regimen
- 35 mg/m\^2 of Selinexor PO twice weekly on a days 1 and 3 schedule (Mon/Wed, Tues/Thurs, or Wed/Fri) on Weeks 1-3, Week 4 rest, on a 28 day course (Amendment 1)
- analyzed count
- 12
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02323880-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-recurrent-childhood-glioblastoma
- nct id
- NCT02323880
- outcome key
- om-0001
- arm key
- OG002
- arm label
- Part A: Dose Level -1 (DL -1)
- regimen
- 20 mg/m\^2 of Selinexor PO twice weekly on a days 1 and 3 schedule (Mon/Wed, Tues/Thurs, or Wed/Fri) on Weeks 1-3, Week 4 rest, on a 28 day course
- analyzed count
- 6
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02323880-om-0001#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-recurrent-childhood-glioblastoma
- nct id
- NCT02323880
- outcome key
- om-0001
- arm key
- OG003
- arm label
- Part A: Weekly Dose Level 1 (WDL 1)
- regimen
- 45 mg/m\^2 Selinexor once weekly, on days 1, 8, 15, and 22 of a 28-day cycle
- analyzed count
- 6
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02323880-om-0001#groups/OG003
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-recurrent-childhood-glioblastoma
- nct id
- NCT02323880
- harm key
- EG000
- source section id
- NCT02323880-ae
- event group key
- EG000
- event group label
- Part A: Dose Level 1
- serious affected
- 1
- serious at risk
- 6
- other affected
- 6
- other at risk
- 6
- frequency threshold
- 0
- collection period
- Up to 7 years 8 months
- event definition
- Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-recurrent-childhood-glioblastoma
- nct id
- NCT02323880
- harm key
- EG001
- source section id
- NCT02323880-ae
- event group key
- EG001
- event group label
- Part A: Dose Level 1 (DL1)(Amendment 1)
- serious affected
- 5
- serious at risk
- 13
- other affected
- 13
- other at risk
- 13
- frequency threshold
- 0
- collection period
- Up to 7 years 8 months
- event definition
- Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-recurrent-childhood-glioblastoma
- nct id
- NCT02323880
- harm key
- EG002
- source section id
- NCT02323880-ae
- event group key
- EG002
- event group label
- Part A: Dose Level -1 (DL-1)
- serious affected
- 3
- serious at risk
- 6
- other affected
- 6
- other at risk
- 6
- frequency threshold
- 0
- collection period
- Up to 7 years 8 months
- event definition
- Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-recurrent-childhood-glioblastoma
- nct id
- NCT02323880
- harm key
- EG003
- source section id
- NCT02323880-ae
- event group key
- EG003
- event group label
- Part A: Weekly Dose Level 1 (WDL 1)
- serious affected
- 2
- serious at risk
- 6
- other affected
- 6
- other at risk
- 6
- frequency threshold
- 0
- collection period
- Up to 7 years 8 months
- event definition
- Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-recurrent-childhood-glioblastoma
- nct id
- NCT02323880
- harm key
- EG004
- source section id
- NCT02323880-ae
- event group key
- EG004
- event group label
- Part A: Weekly Dose Level -1 (WDL -1)
- serious affected
- 3
- serious at risk
- 6
- other affected
- 6
- other at risk
- 6
- frequency threshold
- 0
- collection period
- Up to 7 years 8 months
- event definition
- Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-recurrent-childhood-glioblastoma
- nct id
- NCT02323880
- harm key
- EG005
- source section id
- NCT02323880-ae
- event group key
- EG005
- event group label
- Part B: Weekly Dose Level -1 (WDL -1)
- serious affected
- 3
- serious at risk
- 10
- other affected
- 10
- other at risk
- 10
- frequency threshold
- 0
- collection period
- Up to 7 years 8 months
- event definition
- Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-recurrent-childhood-glioblastoma
- nct id
- NCT02323880
- harm key
- EG006
- source section id
- NCT02323880-ae
- event group key
- EG006
- event group label
- Part PK: Dose Level -1 (DL -1)
- serious affected
- 0
- serious at risk
- 6
- other affected
- 6
- other at risk
- 6
- frequency threshold
- 0
- collection period
- Up to 7 years 8 months
- event definition
- Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-recurrent-childhood-glioblastoma
- nct id
- NCT02323880
- harm key
- EG007
- source section id
- NCT02323880-ae
- event group key
- EG007
- event group label
- Part PK: Weekly Dose Level -1 (DL -1)
- serious affected
- 3
- serious at risk
- 6
- other affected
- 6
- other at risk
- 6
- frequency threshold
- 0
- collection period
- Up to 7 years 8 months
- event definition
- Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice