TriangleNCT03698994 · STUDY IN CONTEXT
Ulixertinib in Treating Patients With Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With MAPK Pathway Mutations (A Pediatric MATCH Treatment Trial)
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
Will be performed and will be summarized with simple summary statistics. All of these analyses will be descriptive in nature.
Will be performed and will be summarized with simple summary statistics. All of these analyses will be descriptive in nature.
ORR will be defined as complete response + partial response and assessed by Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Response rates will be calculated as the percent of evaluable patients who are responders, and confidence intervals will be constructed using the Wilson score interval method.
PFS along with the confidence intervals will be estimated using the Kaplan-Meier method.
Will be graded according to Common Terminology Criteria for Adverse Events version 5.0. Any eligible patient who receives at least one dose of protocol therapy will be considered in the evaluation of toxicity.
Will be summarized with simple summary statistics, including means, medians, ranges, and standard deviations (if numbers and distribution permit).
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-osteosarcoma
- nct id
- NCT03698994
- trial label
- Ulixertinib in Treating Patients With Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With MAPK Pathway Mutations (A Pediatric MATCH Treatment Trial)
- 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-osteosarcoma
- nct id
- NCT03698994
- outcome key
- om-0004
- source section id
- NCT03698994-om-0004
- source outcome index
- 4
- endpoint
- Other Biomarkers as Predictors of Response to Ulixertinib and Whether Tumors That Harbor Different Mutations or Fusions Will Demonstrate Differential Response to Treatment
- endpoint definition
- Will be performed and will be summarized with simple summary statistics. All of these analyses will be descriptive in nature.
- time origin
- Up to 2 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-osteosarcoma
- nct id
- NCT03698994
- outcome key
- om-0005
- source section id
- NCT03698994-om-0005
- source outcome index
- 5
- endpoint
- Profiling Changes in Tumor Genomics Over Time Through Evaluation of Circulating Tumor Deoxyribonucleic Acid (DNA)
- endpoint definition
- Will be performed and will be summarized with simple summary statistics. All of these analyses will be descriptive in nature.
- time origin
- Up to 2 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-osteosarcoma
- nct id
- NCT03698994
- outcome key
- om-0000
- source section id
- NCT03698994-om-0000
- source outcome index
- 0
- endpoint
- Objective Response Rate (ORR = Complete Response [CR] + Partial Response [PR]) in Pediatric Patients Treated With BVD-523FB (Ulixertinib)
- endpoint definition
- ORR will be defined as complete response + partial response and assessed by Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Response rates will be calculated as the percent of evaluable patients who are responders, and confidence intervals will be constructed using the Wilson score interval method.
- time origin
- From enrollment to the end of treatment, up to 2 years
- 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-osteosarcoma
- nct id
- NCT03698994
- outcome key
- om-0001
- source section id
- NCT03698994-om-0001
- source outcome index
- 1
- endpoint
- Progression Free Survival (PFS) in Pediatric Patients Treated With Ulixertinib
- endpoint definition
- PFS along with the confidence intervals will be estimated using the Kaplan-Meier method.
- time origin
- From initiation of treatment to disease progression, disease recurrence, or death from any cause assessed up to 2 years
- analysis role
- secondary
- 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-osteosarcoma
- nct id
- NCT03698994
- outcome key
- om-0002
- source section id
- NCT03698994-om-0002
- source outcome index
- 2
- endpoint
- Percentage of Patients Experiencing Grade 3 or 4 Adverse Events
- endpoint definition
- Will be graded according to Common Terminology Criteria for Adverse Events version 5.0. Any eligible patient who receives at least one dose of protocol therapy will be considered in the evaluation of toxicity.
- time origin
- From enrollment to the end of treatment, up to 2 years
- analysis role
- secondary
- 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-osteosarcoma
- nct id
- NCT03698994
- outcome key
- om-0003
- source section id
- NCT03698994-om-0003
- source outcome index
- 3
- endpoint
- Preliminary Estimates of the Pharmacokinetics of Ulixertinib in Children and Adolescents With Relapsed or Refractory Cancer
- endpoint definition
- Will be summarized with simple summary statistics, including means, medians, ranges, and standard deviations (if numbers and distribution permit).
- time origin
- Pre-dose and 1, 2, 4, and 6-8 hours after dose on cycle 1, day 1; and pre-dose on cycle 1, day 2, and cycle 1, day 15
- analysis role
- secondary
- 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
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-osteosarcoma
- nct id
- NCT03698994
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Treatment (Ulixertinib)
- regimen
- Patients receive ulixertinib PO BID. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 20
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03698994-om-0000#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-osteosarcoma
- nct id
- NCT03698994
- harm key
- EG000
- source section id
- NCT03698994-ae
- event group key
- EG000
- event group label
- Treatment (Ulixertinib)
- serious affected
- 13
- serious at risk
- 20
- other affected
- 20
- other at risk
- 20
- frequency threshold
- 0
- collection period
- From enrollment to 30 days after the end of treatment, up to 2 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