TriangleNCT03213678 · STUDY IN CONTEXT
Samotolisib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With TSC or PI3K/MTOR Mutations (A Pediatric MATC
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
A descriptive analysis will be performed and will be summarized with simple summary statistics. All of these analyses will be descriptive in nature.
A descriptive analysis will be performed and will be summarized with simple summary statistics. All of these analyses will be descriptive in nature.
A responder is defined as a patient who achieves a best response of partial response or complete response on the study. Response rates will be calculated as the percent of evaluable patients who are responders. The revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) was used to determine response and progression in this study, with specific criteria outlined for the different subtypes of tumors (e.g., 2-dimensional measurements for central nervous system (CNS) tumors).
Percentage of patients experiencing grade 3 or higher adverse events will be evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0
The Kaplan-Meier method will be used to estimate the 3-month PFS. PFS is defined as time from initiation of protocol treatment to disease progression, recurrence, death from any cause, or date of last contact.
The mean (sd) of the AUC
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-ewing-sarcoma
- nct id
- NCT03213678
- trial label
- Samotolisib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With TSC or PI3K/MTOR Mutations (A Pediatric MATC
- 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
- 6
- harms Count
- 1
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-ewing-sarcoma
- nct id
- NCT03213678
- outcome key
- om-0004
- source section id
- NCT03213678-om-0004
- source outcome index
- 4
- endpoint
- Potential Predictive Biomarker Identification Using Additional Genomic, Transcriptomic, and Proteomic Testing Platforms
- endpoint definition
- A descriptive analysis will be performed and will be summarized with simple summary statistics. All of these analyses will be descriptive in nature.
- time origin
- Up to 3 years
- analysis role
- exploratory
- reporting status
- NOT_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-ewing-sarcoma
- nct id
- NCT03213678
- outcome key
- om-0005
- source section id
- NCT03213678-om-0005
- source outcome index
- 5
- endpoint
- Biallelic Loss of Function Frequency and Mechanism
- endpoint definition
- A descriptive analysis will be performed and will be summarized with simple summary statistics. All of these analyses will be descriptive in nature.
- time origin
- Up to 3 years
- analysis role
- exploratory
- reporting status
- NOT_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-ewing-sarcoma
- nct id
- NCT03213678
- outcome key
- om-0000
- source section id
- NCT03213678-om-0000
- source outcome index
- 0
- endpoint
- Objective Response Rate
- endpoint definition
- A responder is defined as a patient who achieves a best response of partial response or complete response on the study. Response rates will be calculated as the percent of evaluable patients who are responders. The revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) was used to determine response and progression in this study, with specific criteria outlined for the different subtypes of tumors (e.g., 2-dimensional measurements for central nervous system (CNS) tumors).
- time origin
- Up to 2 years from study entry
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- One patient did not receive any protocol treatment and is excluded from this 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-ewing-sarcoma
- nct id
- NCT03213678
- outcome key
- om-0001
- source section id
- NCT03213678-om-0001
- source outcome index
- 1
- endpoint
- Percentage of Patients Experiencing Grade 3 or 4 Adverse Events
- endpoint definition
- Percentage of patients experiencing grade 3 or higher adverse events will be evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0
- time origin
- Up to 2 years from study entry
- 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-ewing-sarcoma
- nct id
- NCT03213678
- outcome key
- om-0002
- source section id
- NCT03213678-om-0002
- source outcome index
- 2
- endpoint
- Progression Free Survival (PFS)
- endpoint definition
- The Kaplan-Meier method will be used to estimate the 3-month PFS. PFS is defined as time from initiation of protocol treatment to disease progression, recurrence, death from any cause, or date of last contact.
- time origin
- Up to 3 months from study entry
- 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-ewing-sarcoma
- nct id
- NCT03213678
- outcome key
- om-0003
- source section id
- NCT03213678-om-0003
- source outcome index
- 3
- endpoint
- Pharmacokinetic (PK) of Samotolisib, Area Under the Curve (AUC).
- endpoint definition
- The mean (sd) of the AUC
- time origin
- Up to day 15 of cycle 1
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Three of the enrolled patients had PK data available for analysis
- 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-ewing-sarcoma
- nct id
- NCT03213678
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Treatment (Samotolisib)
- regimen
- Patients receive samotolisib PO BID on days 1-28. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unexpected toxicity. Patients undergo an x-ray, CT, MRI, FDG-PET, and blood sample collection on study.
- analyzed count
- 17
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03213678-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-ewing-sarcoma
- nct id
- NCT03213678
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Treatment (Samotolisib)
- regimen
- Patients receive samotolisib PO BID on days 1-28. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unexpected toxicity. Patients undergo an x-ray, CT, MRI, FDG-PET, and blood sample collection on study.
- analyzed count
- 17
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03213678-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-ewing-sarcoma
- nct id
- NCT03213678
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Treatment (Samotolisib)
- regimen
- Patients receive samotolisib PO BID on days 1-28. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unexpected toxicity. Patients undergo an x-ray, CT, MRI, FDG-PET, and blood sample collection on study.
- analyzed count
- 17
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03213678-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-ewing-sarcoma
- nct id
- NCT03213678
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Treatment (Samotolisib)
- regimen
- Patients receive samotolisib PO BID on days 1-28. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unexpected toxicity. Patients undergo an x-ray, CT, MRI, FDG-PET, and blood sample collection on study.
- analyzed count
- 3
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03213678-om-0003#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-ewing-sarcoma
- nct id
- NCT03213678
- harm key
- EG000
- source section id
- NCT03213678-ae
- event group key
- EG000
- event group label
- Treatment (Samotolisib)
- serious affected
- 9
- serious at risk
- 17
- other affected
- 16
- other at risk
- 17
- frequency threshold
- 0
- collection period
- Adverse Events monitored/assessed from enrollment to 30 days after the end of treatment, up to 2 years. All-Cause Mortality monitored/assessed up to 5 years
- 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. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
- 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