TriangleNCT03210714 · STUDY IN CONTEXT
Erdafitinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With FGFR Mutations (A Pediatric MATCH Treatment
Draft scope assessment: unclear. Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. 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 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 6 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
A descriptive analysis of PK parameters will be performed to define systemic exposure, drug clearance, and other pharmacokinetic parameters. The PK parameters 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-ependymoma-pediatric-recurrent-72f73bfa
- nct id
- NCT03210714
- trial label
- Erdafitinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With FGFR Mutations (A Pediatric MATCH Treatment
- applicability
- unclear
- applicability note
- Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
- 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
- 5
- harms Count
- 1
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-ependymoma-pediatric-recurrent-72f73bfa
- nct id
- NCT03210714
- outcome key
- om-0004
- source section id
- NCT03210714-om-0004
- source outcome index
- 4
- endpoint
- Changes in Tumor Genomic Profile
- 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-ependymoma-pediatric-recurrent-72f73bfa
- nct id
- NCT03210714
- outcome key
- om-0000
- source section id
- NCT03210714-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
- 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-ependymoma-pediatric-recurrent-72f73bfa
- nct id
- NCT03210714
- outcome key
- om-0001
- source section id
- NCT03210714-om-0001
- source outcome index
- 1
- endpoint
- Percentage of Patients Experiencing Grade 3 or Higher 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
- 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-ependymoma-pediatric-recurrent-72f73bfa
- nct id
- NCT03210714
- outcome key
- om-0002
- source section id
- NCT03210714-om-0002
- source outcome index
- 2
- endpoint
- Progression Free Survival (PFS)
- endpoint definition
- The Kaplan-Meier method will be used to estimate the 6 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 6 months from study entry
- 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-ependymoma-pediatric-recurrent-72f73bfa
- nct id
- NCT03210714
- outcome key
- om-0003
- source section id
- NCT03210714-om-0003
- source outcome index
- 3
- endpoint
- Pharmacokinetic (PK) Parameters
- endpoint definition
- A descriptive analysis of PK parameters will be performed to define systemic exposure, drug clearance, and other pharmacokinetic parameters. The PK parameters will be summarized with simple summary statistics, including means, medians, ranges, and standard deviations (if numbers and distribution permit).
- time origin
- Pre-dose Cycle 2 Day 1; 1-hour post-dose Cycle 2 Day 1; 2-hour post dose Cycle 2, Day 1; 4-hour post-dose Cycle 2, Day 1; 6-8-hour post-dose, Cycle 2 Day 1; 24-hour post dose, Cycle 2, Day 2
- 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-ependymoma-pediatric-recurrent-72f73bfa
- nct id
- NCT03210714
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Treatment (Erdafitinib)
- regimen
- Patients receive erdafitinib PO QD on days 1-28 of each cycle. Treatment repeats every 28 days for up to 26 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Patients undergo an x-ray, CT scan, MRI, PET scan, radionuclide imaging, and/or bone scan, as well as a bone marrow aspiration and/or biopsy during screening and on study. Patients also undergo blood sample collection on study.
- analyzed count
- 20
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03210714-om-0000#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-ependymoma-pediatric-recurrent-72f73bfa
- nct id
- NCT03210714
- harm key
- EG000
- source section id
- NCT03210714-ae
- event group key
- EG000
- event group label
- Treatment (Erdafitinib)
- serious affected
- 10
- serious at risk
- 20
- other affected
- 19
- other at risk
- 20
- frequency threshold
- 0
- collection period
- Up to 2 years from study entry.
- 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