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Tyrosine Kinase Inhibitor

Erdafitinib for Solid Tumors (RAGNAR Trial)

Phase 2
Waitlist Available
Research Sponsored by Janssen Research & Development, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologic demonstration of an unresectable, locally advanced, or metastatic solid tumor malignancy with an fibroblast growth factor receptor (FGFR) mutation or FGFR gene fusion
Documented progression of disease, defined as any progression that requires a change in treatment, prior to full study screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 years and 9 months
Awards & highlights

RAGNAR Trial Summary

This trial will study whether a drug called erdafitinib can help to shrink tumors in people with advanced solid tumors that have FGFR alterations.

Who is the study for?
This trial is for adults and children with advanced solid tumors that have specific genetic changes called FGFR mutations or fusions. Participants must have tried at least one treatment before, or be a child without standard therapy options. They can't join if they've had certain treatments recently, have specific resistance mutations, other active cancers needing treatment, or certain lung cancer gene changes.Check my eligibility
What is being tested?
The study tests the drug Erdafitinib's effectiveness in shrinking tumors by measuring the overall response rate (ORR) in patients with these FGFR alterations. It includes both adult and pediatric participants who meet the criteria.See study design
What are the potential side effects?
While not specified here, drugs like Erdafitinib typically may cause side effects such as diarrhea, dry mouth, nail problems, skin reactions, high phosphate levels leading to muscle cramps or weakness; however individual experiences can vary.

RAGNAR Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My cancer is advanced and cannot be surgically removed, with a specific FGFR gene change.
Select...
My cancer has worsened, needing a change in treatment before full study screening.

RAGNAR Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 years and 9 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 years and 9 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall Response Rate (ORR) as Assessed by Independent Review Committee (IRC)
Secondary outcome measures
Change from Baseline in Health-Related Quality of Life (HRQoL) as Assessed by European Organisation for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 (EORTC-QLQ-C30) Scale Score
Change from Baseline in Health-Related Quality of Life as Assessed by European Quality of Life - 5 Dimensions-5 Levels (EQ-5D-5L) Scale Score
Change from Baseline in Health-Related Quality of Life as Assessed by Patient Global Impression of Change (PGIC) Scale
+11 more

RAGNAR Trial Design

1Treatment groups
Experimental Treatment
Group I: ErdafitinibExperimental Treatment1 Intervention
Participants with fibroblast growth factor receptor (FGFR) mutations and FGFR gene fusions will receive a dose of erdafitinib oral tablets until disease progression, intolerable toxicity, withdrawal of consent, decision by the investigator to discontinue treatment, or end of data collection timepoint if there is clinical benefit in the opinion of the investigator, has been achieved.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Erdafitinib
2017
Completed Phase 2
~150

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
975 Previous Clinical Trials
6,383,992 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
745 Previous Clinical Trials
3,959,589 Total Patients Enrolled

Media Library

Erdafitinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04083976 — Phase 2
Solid Tumors Research Study Groups: Erdafitinib
Solid Tumors Clinical Trial 2023: Erdafitinib Highlights & Side Effects. Trial Name: NCT04083976 — Phase 2
Erdafitinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04083976 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this experiment still available to participants?

"Affirmative. Information posted on clinicaltrials.gov confirms that this study is still recruiting, with 336 participants needed across 23 different sites since its inception in November 20th 2019 and the last edit of November 3rd 2022."

Answered by AI

To what extent is this clinical trial accessible across different locations?

"The medical trial is currently accepting participants from 23 sites, including Toronto, Montreal and Hackensack. To ease the burden of travel demands on patients, it may be advantageous to select a clinic in close proximity."

Answered by AI

Are there previous experiments that have employed Erdafitinib?

"Erdafitinib received its first clinical trial in 2015 at Hosp. Univ. Marques de Valdecilla, and 11 additional trials have since been completed. Currently, 15 active studies are underway internationally; notably many of these investigations take place within the city limits of Toronto, Ontario."

Answered by AI

What is the admittance capacity for this medical experiment?

"This research requires 336 qualified participants. These individuals can be recruited from multiple locations, including the Hospital For Sick Children in Toronto and Montreal Children's Hospital in Quebec."

Answered by AI

Has Erdafitinib been given the green light by the FDA?

"Our internal analysis at Power has given Erdafitinib a score of 2, which alludes to the presence of safety data that was collected during Phase 2 but not efficacy data."

Answered by AI

Is this endeavor the initial instance of its kind?

"The exploration of the pharmacological capabilities of erdafitinib began in 2015, when Janssen Research & Development funded a trial involving 255 participants. After successful Phase 2 testing, there are now 15 ongoing trials with locations spanning 903 cities and 37 nations."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study of Erdafitinib in Participants With Advanced Solid Tumors and Fibroblast Growth Factor Receptor (FGFR) Gene Alterations
2019. "A Study of Erdafitinib in Participants With Advanced Solid Tumors and Fibroblast Growth Factor Receptor (FGFR) Gene Alterations". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04083976.
~58 spots leftby Apr 2025
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