Trial · NCT04083976
A Study of Erdafitinib in Participants With Advanced Solid Tumors and Fibroblast Growth Factor Receptor (FGFR) Gene Alterations
NCT04083976, Phase 2, Completed, Janssen Research & Development, LLC; results first posted 2025-02-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Erdafitinib in Participants With Advanced Solid Tumors and Fibroblast Growth Factor Receptor (FGFR) Gene Alterations. Trials, record NCT04083976. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04083976
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Erdafitinib in Participants With Advanced Solid Tumors and Fibroblast Growth Factor Receptor (FGFR) Gene Alterations
- NCT number
- NCT04083976
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 316 participants, actual
- Lead sponsor
- Janssen Research & Development, LLC
- Conditions
- Advanced Solid Tumor
- Interventions
- Erdafitinib
- First posted
- 2019-09-10
- Last updated
- 2026-09-17
- Other registries' IDs
- eudract:2019-002113-19
- Results first posted
- 2025-02-24
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| 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 | The treated population consisted of all participants in broad panel and pediatric cohorts who received at least 1 dose of study drug. | Percentage of participants | NUMBER |
| 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 | The treated population (core panel) consisted of a subgroup of participants in the broad panel cohort (fibroblast growth factor receptor \[FGFR+\]) with a select panel of pre-specified FGFR markers who received at least 1 dose of study drug. | Percentage of participants | NUMBER |
| SECONDARY | Objective Response Rate (ORR) as Assessed by Investigators 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 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Broad Panel and Pediatric Cohorts: Objective Response Rate (ORR) Based on Response Assessment in Neuro-Oncology (RANO) as Assessed by Independent Review Committee (IRC) | Broad Panel Cohort | 29.5 | 95% Confidence Interval 23.5 to 36.0 | Percentage of participants | |
| Broad Panel and Pediatric Cohorts: Objective Response Rate (ORR) Based on Response Assessment in Neuro-Oncology (RANO) as Assessed by Independent Review Committee (IRC) | Pediatric Cohort | 66.7 | 95% Confidence Interval 9.4 to 99.2 | Percentage of participants | |
| Core Panel Cohort: Objective Response Rate (ORR) Based on Response Assessment in Neuro-Oncology (RANO) as Assessed by Independent Review Committee (IRC) | Core Panel Cohort | 26.6 | 95% Confidence Interval 18.6 to 35.9 | Percentage of participants |
Source ClinicalTrials.gov
Participant flow20
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Broad Panel Cohort | 217 | |
| Overall Study | STARTED | Cholangiocarcinoma (CCA) Expansion Cohort | 35 | |
| Overall Study | STARTED | Exploratory Cohort | 53 | |
| Overall Study | STARTED | Pediatric Cohort | 11 | |
| Overall Study | Adolescent Participants From Broad Panel Cohort | Broad Panel Cohort | 0 | |
| Overall Study | Adolescent Participants From Broad Panel Cohort | Cholangiocarcinoma (CCA) Expansion Cohort | 0 | |
| Overall Study | Adolescent Participants From Broad Panel Cohort | Exploratory Cohort | 0 | |
| Overall Study | Adolescent Participants From Broad Panel Cohort | Pediatric Cohort | 2 | |
| Overall Study | Core Panel Cohort | Broad Panel Cohort | 109 | |
| Overall Study | Core Panel Cohort | Cholangiocarcinoma (CCA) Expansion Cohort | 0 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 participant flowAdverse events1,132
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Broad Panel Cohort | 57 | 217 | |
| other | Anaemia | Blood and lymphatic system disorders | Cholangiocarcinoma (CCA) Expansion Cohort | 13 | 35 | |
| other | Anaemia | Blood and lymphatic system disorders | Exploratory Cohort | 9 | 53 | |
| other | Anaemia | Blood and lymphatic system disorders | Pediatric Cohort | 3 | 11 | |
| other | Leukopenia | Blood and lymphatic system disorders | Broad Panel Cohort | 12 | 217 | |
| other | Leukopenia | Blood and lymphatic system disorders | Cholangiocarcinoma (CCA) Expansion Cohort | 2 | 35 | |
| other | Leukopenia | Blood and lymphatic system disorders | Exploratory Cohort | 0 | 53 | |
| other | Leukopenia | Blood and lymphatic system disorders | Pediatric Cohort | 1 | 11 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Broad Panel Cohort | 10 | 217 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Cholangiocarcinoma (CCA) Expansion Cohort | 1 | 35 |
1 to 10 of 1,132Source ClinicalTrials.gov
See all 1,132 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Broad Panel Cohort | 8 | 217 |
| Total, all-cause mortality | Cholangiocarcinoma (CCA) Expansion Cohort | 1 | 35 |
| Total, all-cause mortality | Exploratory Cohort | 1 | 53 |
| Total, all-cause mortality | Pediatric Cohort | 1 | 11 |
| Total, other adverse events | Broad Panel Cohort | 215 | 217 |
| Total, other adverse events | Cholangiocarcinoma (CCA) Expansion Cohort | 35 | 35 |
| Total, other adverse events | Exploratory Cohort | 53 | 53 |
| Total, other adverse events | Pediatric Cohort | 11 | 11 |
| Total, serious adverse events | Broad Panel Cohort | 86 | 217 |
| Total, serious adverse events | Cholangiocarcinoma (CCA) Expansion Cohort | 15 | 35 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04083976
GET https://conductscience.org/api/trials/v1/NCT04083976/events?page=2