Trial · NCT04083976
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Broad Panel and Pediatric Cohorts: Objective Response Rate (ORR) Based on Response Assessment in Neuro-Oncology (RANO) as Assessed by Independent Review Committee (IRC) | Baseline (Cycle 1 Day 1 [each cycle of 21 days]) up to 4 years | ORR is defined as the percentage of participants who achieved a complete response (CR), or partial response (PR) based on Response Assessment in Neuro-Oncology (RANO) criteria. According to RANO criteria whereby overall RANO response is based on both radiographic response (CR: disappearance of all target lesions; PR: sum of products of diameters \[SPD\] decreased by \>=50 percent \[%\] from baseline value) and clinical performance status with steroid dose information. |
| Primary | Core Panel Cohort: Objective Response Rate (ORR) Based on Response Assessment in Neuro-Oncology (RANO) as Assessed by Independent Review Committee (IRC) | Baseline (Cycle 1 Day 1 [each cycle of 21 days]) up to 4 years | ORR is defined as the percentage of participants who achieved a CR, or PR based on RANO criteria. According to RANO criteria whereby overall RANO response is based on both radiographic response (CR: disappearance of all target lesions; PR: sum of products of diameters \[SPD\] decreased by \>=50 percent \[%\] from baseline value) and clinical performance status with steroid dose information. The core panel cohort is a subgroup of the broad panel cohort with a select panel of pre-specified FGFR markers: FGFR3 mutations (S249C;Y373C; R248C; G370C); FGFR2 mutations (C382R); FGFR3 fusions (FGFR3-TACC3); FGFR2 fusions (FGFR2-BICC1; FGFR2-TACC2). |
| Secondary | Objective Response Rate (ORR) as Assessed by Investigator Assessment | Baseline (Cycle 1 Day 1 [each cycle of 21 days]) up to 5 years 4 months | |
| Secondary | Duration of Responses (DOR) | Baseline (Cycle 1 Day 1 [each cycle of 21 days]) up to 5 years 4 months | |
| Secondary | Disease Control Rate (DCR) | Baseline (Cycle 1 Day 1 [each cycle of 21 days]) up to 5 years 4 months | |
| Secondary | Clinical Benefit Rate (CBR) | Baseline (Cycle 1 Day 1 [each cycle of 21 days]) up to 5 years 4 months | |
| Secondary | Progression-free Survival (PFS) | Baseline (Cycle 1 Day 1 [each cycle of 21 days]) up to 5 years 4 months | |
| Secondary | Overall Survival (OS) | Baseline (Cycle 1 Day 1 [each cycle of 21 days]) up to 5 years 4 months | |
| Secondary | Number of Participants With Adverse Events (AEs) | Baseline (Cycle 1 Day 1 [each cycle of 21 days]) up to 5 years 4 months | |
| Secondary | Number of Participants With Adverse Events (AEs) by Severity | Baseline (Cycle 1 Day 1 [each cycle of 21 days]) up to 5 years 4 months | |
| Secondary | Plasma Concentration of Erdafitinib | Baseline (Cycle 1 Day 1 [each cycle of 21 days]) up to 5 years 4 months | |
| Secondary | Broad Panel, CCA Expansion, and Exploratory Cohorts: Change From Baseline in European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 (EORTC-QLQ-C30) | Baseline (Cycle 1 Day 1 [each cycle of 21 days]) up to 5 years 4 months | |
| Secondary | Pediatric Cohorts: Change From Baseline in Pediatric Functional Assessment Of Cancer Therapy-Brain (Peds FACT-Br) | Baseline (Cycle 1 Day 1 [each cycle of 21 days]) up to 5 years 4 months | |
| Secondary | Change From Baseline in Patient Global Impression of Symptom Severity (PGIS) | Baseline (Cycle 1 Day 1 [each cycle of 21 days]) up to 5 years 4 months | |
| Secondary | Change From Baseline in Patient Global Impression of Change (PGIC) | Baseline (Cycle 1 Day 1 [each cycle of 21 days]) up to 5 years 4 months | |
| Secondary | Change From Baseline in European Quality of Life -5 Dimensions-5 Levels (EQ-5D-5L) | Baseline (Cycle 1 Day 1 [each cycle of 21 days]) up to 5 years 4 months |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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GET https://conductscience.org/api/trials/v1/NCT04083976/registered