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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04083976
Registration number
NCT04083976
Ethics application status
Date submitted
6/09/2019
Date registered
10/09/2019
Date last updated
22/05/2024
Titles & IDs
Public title
A Study of Erdafitinib in Participants With Advanced Solid Tumors and Fibroblast Growth Factor Receptor (FGFR) Gene Alterations
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Scientific title
A Phase 2 Study of Erdafitinib in Subjects With Advanced Solid Tumors and FGFR Gene Alterations
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Secondary ID [1]
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2019-002113-19
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Secondary ID [2]
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CR108661
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Universal Trial Number (UTN)
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Trial acronym
RAGNAR
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Tumor
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0
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Overall Response Rate (ORR) as Assessed by Independent Review Committee (IRC)
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Assessment method [1]
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ORR as assessed by IRC is defined as the percentage of participants who achieve a complete response (CR) or partial response (PR).
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Timepoint [1]
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Up to 6 years and 9 months
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Secondary outcome [1]
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Overall Response Rate as Assessed by Investigator
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Assessment method [1]
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ORR as assessed by investigator is defined as the percentage of participants who achieve a CR or PR.
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Timepoint [1]
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Up to 6 years and 9 months
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Secondary outcome [2]
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Duration of Response (DOR)
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Assessment method [2]
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DOR is the duration from the date of initial documentation of a response to the date of first documented evidence of progressive disease (or relapse for participants who experience CR during the study), or death, whichever comes first.
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Timepoint [2]
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Up to 6 years and 9 months
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Secondary outcome [3]
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Disease Control Rate (DCR)
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Assessment method [3]
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DCR is defined as the percentage of participants with CR, PR or stable disease (SD).
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Timepoint [3]
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Up to 6 years and 9 months
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Secondary outcome [4]
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Clinical Benefit Rate (CBR)
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Assessment method [4]
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CBR is defined as the percentage of participants with CR, PR or durable SD.
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Timepoint [4]
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Up to 6 years and 9 months
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Secondary outcome [5]
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Progression Free Survival (PFS)
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Assessment method [5]
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PFS is the duration from the date of the first dose of study drug until the date of first documented evidence of progressive disease (or relapse for participants who experience CR during the study) or death, whichever comes first.
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Timepoint [5]
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Up to 6 years and 9 months
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Secondary outcome [6]
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Overall Survival (OS)
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Assessment method [6]
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OS will be measured from the date of first dose of study drug to the date of the participant's death.
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Timepoint [6]
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Up to 6 years and 9 months
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Secondary outcome [7]
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Plasma Concentrations of Erdafitinib
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Assessment method [7]
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Plasma concentrations of erdafitinib will be reported.
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Timepoint [7]
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Predose and 2-4 hours postdose
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Secondary outcome [8]
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Number of Participants with Adverse Events (AEs)
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Assessment method [8]
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An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An adverse event does not necessarily have a causal relationship with the relevant investigational product.
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Timepoint [8]
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Up to 6 years and 9 months
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Secondary outcome [9]
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Number of Participants with Adverse Events by Severity
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Assessment method [9]
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An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. Adverse event severity is a clinical determination of the intensity of an adverse event.
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Timepoint [9]
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Up to 6 years and 9 months
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Secondary outcome [10]
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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
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Assessment method [10]
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The EORTC QLQ-C30 includes 30 items in 5 functional scales, 1 global health status scale, 3 symptom scales, and 6 single symptom items. The responses are reported using a verbal rating scale. The item and scale scores are transformed to a 0 to 100 scale. A higher score represents greater HRQoL, better functioning, and more (worse) symptoms.
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Timepoint [10]
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Baseline; up to 2 years and 9 months
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Secondary outcome [11]
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Change from Baseline in Health-Related Quality of Life as Assessed by Patient Global Impression of Symptom Severity (PGIS) Scale Score
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Assessment method [11]
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The PGIS is a single question regarding the patient report of disease severity: considering all aspects of your cancer symptoms right now would you say your cancer symptoms are none, mild, moderate, severe, or very severe?
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Timepoint [11]
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Baseline; up to 2 years and 9 months
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Secondary outcome [12]
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Change from Baseline in Health-Related Quality of Life as Assessed by Patient Global Impression of Change (PGIC) Scale
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Assessment method [12]
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The PGIC is the patient-reported outcome (PRO) counterpart to the clinical global impressions (CGI) scale. The PGIC is a single verbal rating scale ranging from 1 = a lot better now to 7 = a lot worse now.
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Timepoint [12]
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Baseline; up to 2 years and 9 months
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Secondary outcome [13]
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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
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Assessment method [13]
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The EQ-5D-5L is a generic measure of health status. The EQ-5D-5L is a 5-item questionnaire that assesses 5 domains including mobility, self-care, usual activities, pain/discomfort and anxiety/depression plus a visual analog scale rating "health today" with anchors ranging from 0 (worst imaginable health state) to 100 (best imaginable health state).
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Timepoint [13]
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Baseline; up to 2 years and 9 months
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Secondary outcome [14]
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Change from Baseline in Pediatric Functional Assessment of Cancer Therapy - Brain (Peds FACT-Br) Total Score
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Assessment method [14]
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Peds FACT-Br consists of 4 sets of disease-specific questions pertaining to brain neoplasms (a set of 34 to 37 questions each for child, parent of child, adolescent or parent of adolescent). Peds FACT-Br total score for child ranges from 0-136 and for parent of child, adolescent and parent of adolescent the score ranges from 0-148. Here '0' indicates a severely "symptomatic participant" and highest score indicates "asymptomatic participant".
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Timepoint [14]
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Baseline; up to 2 years and 9 months
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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
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Minimum age
6
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
20/11/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
20/09/2024
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Actual
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Sample size
Target
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Accrual to date
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Final
316
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Flinders Centre for Innovation in Cancer - Adelaide
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Recruitment hospital [2]
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Chris O'Brien Lifehouse - Camperdown
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Recruitment hospital [3]
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St. Vincent's Hospital Sydney - Darlinghurst
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Recruitment hospital [4]
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St Vincents Hospital Melbourne - Fitzroy
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Recruitment hospital [5]
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Fiona Stanley Hospital - Murdoch
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Recruitment hospital [6]
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Intergrated Clinical Oncology Network Pty Ltd (ICON) - South Brisbane
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Recruitment postcode(s) [1]
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5042 - Adelaide
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Recruitment postcode(s) [2]
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2050 - Camperdown
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Recruitment postcode(s) [3]
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2010 - Darlinghurst
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Recruitment postcode(s) [4]
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3065 - Fitzroy
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Recruitment postcode(s) [5]
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6150 - Murdoch
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Recruitment postcode(s) [6]
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4101 - South Brisbane
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Recruitment outside Australia
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United States of America
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Arizona
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United States of America
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Colorado
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Florida
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United States of America
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Georgia
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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 Jersey
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New York
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United States of America
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North Carolina
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Ohio
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Pennsylvania
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Tennessee
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Texas
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Argentina
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Ciudad Autonoma de Buenos Aires
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Argentina
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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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Argentina
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Mar Del Plata, Buenos Aires
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Argentina
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Mar Del Plata
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Pilar
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Rosario
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Gent
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Curitiba
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Goiania
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Porto Alegre
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Brazil
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Recife
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Brazil
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Beijing
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China
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China
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Caen
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Clermont Ferrand
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Dijon
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Lille
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Lyon
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Poitiers
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France
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Vandoeuvre lès Nancy
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France
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Villejuif
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Germany
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Berlin
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Germany
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Dresden
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Essen
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Frankfurt
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Hamburg
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Germany
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Heidelberg
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Germany
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Mainz
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München
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Tübingen
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Italy
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Monza
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Italy
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Italy
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Pisa
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Italy
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Terni
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Italy
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Verona
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Japan
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Chuo Ku
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Japan
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Hiroshima shi
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Japan
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Kashiwa
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Japan
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Matsuyama
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Japan
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Toyoake
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Korea, Republic of
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Seoul
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Poland
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Bydgoszcz
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Poland
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Konin
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Poland
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Krakow
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Lodz
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Skorzewo
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Poland
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Warszawa
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Spain
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Barcelona
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Spain
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Hospitalet de Llobregat, Barcelona
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Spain
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Madrid
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Spain
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Sevilla
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Spain
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Valencia
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Country [104]
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Taiwan
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State/province [104]
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0
Changhua
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Country [105]
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0
Taiwan
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State/province [105]
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0
Kaohsiung City
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Country [106]
0
0
Taiwan
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State/province [106]
0
0
Kaohsiung
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Country [107]
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0
Taiwan
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State/province [107]
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Taichung
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Country [108]
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0
Taiwan
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State/province [108]
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Tainan
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Country [109]
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Taiwan
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State/province [109]
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Taipei
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Country [110]
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Taiwan
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State/province [110]
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Taoyuan City
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Country [111]
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United Kingdom
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State/province [111]
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Bristol
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Country [112]
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United Kingdom
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State/province [112]
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0
Manchester
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Country [113]
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United Kingdom
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State/province [113]
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Newcastle upon Tyne
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Country [114]
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United Kingdom
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State/province [114]
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0
Plymouth
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Country [115]
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0
United Kingdom
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State/province [115]
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Sutton
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Country [116]
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United Kingdom
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State/province [116]
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Wirral
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Janssen Research & Development, LLC
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Address
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Ethics approval
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Summary
Brief summary
The purpose of this study is to evaluate the efficacy of erdafitinib in terms of overall
response rate (ORR) in adult and pediatric participants with advanced solid tumors with
fibroblast growth factor receptor (FGFR) alterations (mutations or gene fusions). It will
also evaluate ORR in pediatric participants with advanced solid tumors and FGFR alterations.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04083976
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Janssen Research & Development, LLC Clinical Trial
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Address
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Janssen Research & Development, LLC
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0
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04083976
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