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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04083976




Registration number
NCT04083976
Ethics application status
Date submitted
6/09/2019
Date registered
10/09/2019

Titles & IDs
Public title
A Study of Erdafitinib in Participants With Advanced Solid Tumors and Fibroblast Growth Factor Receptor (FGFR) Gene Alterations
Scientific title
A Phase 2 Study of Erdafitinib in Subjects With Advanced Solid Tumors and FGFR Gene Alterations
Secondary ID [1] 0 0
42756493CAN2002
Secondary ID [2] 0 0
CR108661
Universal Trial Number (UTN)
Trial acronym
RAGNAR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Tumor 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Erdafitinib

Experimental: Erdafitinib - 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: Drugs: Erdafitinib
Participants will receive erdafitinib oral tablets.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Broad Panel and Pediatric Cohorts: Objective Response Rate (ORR) Based on Response Assessment in Neuro-Oncology (RANO) as Assessed by Independent Review Committee (IRC)
Timepoint [1] 0 0
Baseline (Cycle 1 Day 1 [each cycle of 21 days]) up to 4 years
Primary outcome [2] 0 0
Core Panel Cohort: Objective Response Rate (ORR) Based on Response Assessment in Neuro-Oncology (RANO) as Assessed by Independent Review Committee (IRC)
Timepoint [2] 0 0
Baseline (Cycle 1 Day 1 [each cycle of 21 days]) up to 4 years
Secondary outcome [1] 0 0
Objective Response Rate (ORR) as Assessed by Investigators Assessment
Timepoint [1] 0 0
Baseline (Cycle 1 Day 1 [each cycle of 21 days]) up to 5 years 4 months
Secondary outcome [2] 0 0
Duration of Responses (DOR)
Timepoint [2] 0 0
Baseline (Cycle 1 Day 1 [each cycle of 21 days]) up to 5 years 4 months
Secondary outcome [3] 0 0
Disease Control Rate (DCR)
Timepoint [3] 0 0
Baseline (Cycle 1 Day 1 [each cycle of 21 days]) up to 5 years 4 months
Secondary outcome [4] 0 0
Clinical Benefit Rate (CBR)
Timepoint [4] 0 0
Baseline (Cycle 1 Day 1 [each cycle of 21 days]) up to 5 years 4 months
Secondary outcome [5] 0 0
Progression-free Survival (PFS)
Timepoint [5] 0 0
Baseline (Cycle 1 Day 1 [each cycle of 21 days]) up to 5 years 4 months
Secondary outcome [6] 0 0
Overall Survival (OS)
Timepoint [6] 0 0
Baseline (Cycle 1 Day 1 [each cycle of 21 days]) up to 5 years 4 months
Secondary outcome [7] 0 0
Number of Participants With Adverse Events (AEs)
Timepoint [7] 0 0
Baseline (Cycle 1 Day 1 [each cycle of 21 days]) up to 5 years 4 months
Secondary outcome [8] 0 0
Number of Participants With Adverse Events (AEs) by Severity
Timepoint [8] 0 0
Baseline (Cycle 1 Day 1 [each cycle of 21 days]) up to 5 years 4 months
Secondary outcome [9] 0 0
Pediatric Cohort: Plasma Concentration of Erdafitinib
Timepoint [9] 0 0
Baseline (Cycle 1 Day 1 [each cycle of 21 days]) up to 5 years 4 months
Secondary outcome [10] 0 0
Change From Baseline in European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 (EORTC-QLQ-C30) for Participants >=18 Years
Timepoint [10] 0 0
Baseline (Cycle 1 Day 1 [each cycle of 21 days]) up to 5 years 4 months
Secondary outcome [11] 0 0
Change From Baseline in Pediatric Functional Assessment Of Cancer Therapy-Brain (Peds FACT-Br)
Timepoint [11] 0 0
Baseline (Cycle 1 Day 1 [each cycle of 21 days]) up to 5 years 4 months
Secondary outcome [12] 0 0
Change From Baseline in Patient Global Impression of Symptom Severity (PGIS)
Timepoint [12] 0 0
Baseline (Cycle 1 Day 1 [each cycle of 21 days]) up to 5 years 4 months
Secondary outcome [13] 0 0
Change From Baseline in Patient Global Impression of Change (PGIC)
Timepoint [13] 0 0
Baseline (Cycle 1 Day 1 [each cycle of 21 days]) up to 5 years 4 months
Secondary outcome [14] 0 0
Change From Baseline in European Quality of Life -5 Dimensions-5 Levels (EQ-5D-5L)
Timepoint [14] 0 0
Baseline (Cycle 1 Day 1 [each cycle of 21 days]) up to 5 years 4 months

Eligibility
Key inclusion criteria
* Histologic demonstration of an unresectable, locally advanced, or metastatic solid tumor malignancy with an fibroblast growth factor receptor (FGFR) mutation or FGFR gene fusion
* Measurable disease
* Participant must have received at least one prior line of systemic therapy in the advanced, unresectable, or metastatic setting; or is a child or adolescent participant with a newly-diagnosed solid tumor and no acceptable standard therapies
* Documented progression of disease, defined as any progression that requires a change in treatment, prior to full study screening
Minimum age
6 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Has had prior chemotherapy, targeted therapy, or treatment with an investigational anticancer agent within 15 days or less than or equal to (<=) 5 half-lives of the agent (whichever is longer) and up to a maximum of 30 days before the first dose of erdafitinib
* The presence of FGFR gatekeeper and resistance mutations
* Histologic demonstration of urothelial carcinoma
* Hematologic malignancy (i.e., myeloid and lymphoid neoplasms
* For non-small cell lung cancer participants only: pathogenic somatic mutations or gene fusions in the following genes: EGFR, ALK, ROS1, NTRK, BRAF V600E and KRAS
* Active malignancies other than for disease requiring therapy

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/11/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
Accrual to date
Final
316
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Flinders Centre for Innovation in Cancer - Adelaide
Recruitment hospital [2] 0 0
Chris O'Brien Lifehouse - Camperdown
Recruitment hospital [3] 0 0
St Vincent s Hospital Sydney - Darlinghurst
Recruitment hospital [4] 0 0
St Vincents Hospital Melbourne - Fitzroy
Recruitment hospital [5] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [6] 0 0
Intergrated Clinical Oncology Network Pty Ltd (ICON) - South Brisbane
Recruitment postcode(s) [1] 0 0
5042 - Adelaide
Recruitment postcode(s) [2] 0 0
2050 - Camperdown
Recruitment postcode(s) [3] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [4] 0 0
3065 - Fitzroy
Recruitment postcode(s) [5] 0 0
6150 - Murdoch
Recruitment postcode(s) [6] 0 0
4101 - South Brisbane
Recruitment outside Australia
Country [1] 0 0
United States of America
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Arizona
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United States of America
State/province [2] 0 0
Colorado
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Florida
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Georgia
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United States of America
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Hawaii
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United States of America
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Maine
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Massachusetts
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Michigan
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New York
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Pennsylvania
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Washington
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Wisconsin
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Ciudad Autónoma de Buenos Aires
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Argentina
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Cordoba
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La Plata Lpl Lpl
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Brasschaat
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Bruxelles
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Charleroi
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Poitiers
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Vandoeuvre lès Nancy
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Toyoake
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Madrid
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Sevilla
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Valencia
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Changhua
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Kaohsiung City
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Taichung
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Tainan
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Taoyuan City
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Bristol
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Manchester
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Newcastle upon Tyne
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Plymouth
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Sutton
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United Kingdom
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Wirral

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Janssen Research & Development, LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Research & Development, LLC Clinical Trial
Address 0 0
Janssen Research & Development, LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

TypeOther DetailsAttachment
Study protocol
Statistical analysis plan



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT04083976