TriangleNCT02186509 · STUDY IN CONTEXT
Alisertib and Fractionated Stereotactic Radiosurgery in Treating Patients With Recurrent 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. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. 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
Defined as the dose at which \>= 2 patients experience dose-limiting toxicity, graded in severity according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
95% confidence intervals will be computed. Response was defined by the Updated Response Assessment Criteria for High-Grade Gliomas: Response Assessment in Neuro-Oncology Work Group (RANO)
Estimated through the Kaplan-Meier method.
Estimated through the Kaplan-Meier method.
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-adult-gliosarcoma
- nct id
- NCT02186509
- trial label
- Alisertib and Fractionated Stereotactic Radiosurgery in Treating Patients With Recurrent 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. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
- 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
- 4
- harms Count
- 1
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-adult-gliosarcoma
- nct id
- NCT02186509
- outcome key
- om-0000
- source section id
- NCT02186509-om-0000
- source outcome index
- 0
- endpoint
- Maximum Tolerated Dose (MTD) of Alisertib
- endpoint definition
- Defined as the dose at which \>= 2 patients experience dose-limiting toxicity, graded in severity according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
- time origin
- Up to 30 days after completion of radiation therapy
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population 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-adult-gliosarcoma
- nct id
- NCT02186509
- outcome key
- om-0001
- source section id
- NCT02186509-om-0001
- source outcome index
- 1
- endpoint
- Number of Participants With Complete or Partial Response
- endpoint definition
- 95% confidence intervals will be computed. Response was defined by the Updated Response Assessment Criteria for High-Grade Gliomas: Response Assessment in Neuro-Oncology Work Group (RANO)
- time origin
- Up to 5 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population 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-adult-gliosarcoma
- nct id
- NCT02186509
- outcome key
- om-0002
- source section id
- NCT02186509-om-0002
- source outcome index
- 2
- endpoint
- Number of Participants With Progression Free Survival at 6 Months
- endpoint definition
- Estimated through the Kaplan-Meier method.
- time origin
- At 6 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population 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-adult-gliosarcoma
- nct id
- NCT02186509
- outcome key
- om-0003
- source section id
- NCT02186509-om-0003
- source outcome index
- 3
- endpoint
- Number of Participants With Overall Survival at 6 Months
- endpoint definition
- Estimated through the Kaplan-Meier method.
- time origin
- At 6 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- 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-adult-gliosarcoma
- nct id
- NCT02186509
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Alisertib, Fractionated Stereotactic Radiosurgery
- regimen
- CONCURRENT PHASE: Patients undergo fractionated stereotactic radiosurgery QD every weekday for 10 days and receive alisertib PO BID concurrently with radiation therapy for 10 days. MAINTENANCE PHASE: Patients receive alisertib PO BID on days 1-7. Treatment repeats every 21 days for up to 18 courses in the absence of disease progression or unacceptable toxicity. Hyperfractionated radiation therapy: Undergo hyperfractionated radiation therapy Stereotactic radiosurgery: Undergo stereotactic radiosurgery Alisertib: Given PO Quality-of-life assessment: Ancillary studies
- analyzed count
- 17
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02186509-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-adult-gliosarcoma
- nct id
- NCT02186509
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Alisertib, Fractionated Stereotactic Radiosurgery
- regimen
- CONCURRENT PHASE: Patients undergo fractionated stereotactic radiosurgery QD every weekday for 10 days and receive alisertib PO BID concurrently with radiation therapy for 10 days. MAINTENANCE PHASE: Patients receive alisertib PO BID on days 1-7. Treatment repeats every 21 days for up to 18 courses in the absence of disease progression or unacceptable toxicity. Hyperfractionated radiation therapy: Undergo hyperfractionated radiation therapy Stereotactic radiosurgery: Undergo stereotactic radiosurgery Alisertib: Given PO Quality-of-life assessment: Ancillary studies
- analyzed count
- 17
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02186509-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-adult-gliosarcoma
- nct id
- NCT02186509
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Alisertib, Fractionated Stereotactic Radiosurgery
- regimen
- CONCURRENT PHASE: Patients undergo fractionated stereotactic radiosurgery QD every weekday for 10 days and receive alisertib PO BID concurrently with radiation therapy for 10 days. MAINTENANCE PHASE: Patients receive alisertib PO BID on days 1-7. Treatment repeats every 21 days for up to 18 courses in the absence of disease progression or unacceptable toxicity. Hyperfractionated radiation therapy: Undergo hyperfractionated radiation therapy Stereotactic radiosurgery: Undergo stereotactic radiosurgery Alisertib: Given PO Quality-of-life assessment: Ancillary studies
- analyzed count
- 17
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02186509-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-adult-gliosarcoma
- nct id
- NCT02186509
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Alisertib, Fractionated Stereotactic Radiosurgery
- regimen
- CONCURRENT PHASE: Patients undergo fractionated stereotactic radiosurgery QD every weekday for 10 days and receive alisertib PO BID concurrently with radiation therapy for 10 days. MAINTENANCE PHASE: Patients receive alisertib PO BID on days 1-7. Treatment repeats every 21 days for up to 18 courses in the absence of disease progression or unacceptable toxicity. Hyperfractionated radiation therapy: Undergo hyperfractionated radiation therapy Stereotactic radiosurgery: Undergo stereotactic radiosurgery Alisertib: Given PO Quality-of-life assessment: Ancillary studies
- analyzed count
- 17
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02186509-om-0003#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-adult-gliosarcoma
- nct id
- NCT02186509
- harm key
- EG000
- source section id
- NCT02186509-ae
- event group key
- EG000
- event group label
- Alisertib, Fractionated Stereotactic Radiosurgery
- serious affected
- 6
- serious at risk
- 17
- other affected
- 17
- other at risk
- 17
- frequency threshold
- 1
- collection period
- 18 months from baseline
- event definition
- Source null
- 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