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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03390504
Registration number
NCT03390504
Ethics application status
Date submitted
20/12/2017
Date registered
4/01/2018
Date last updated
14/08/2024
Titles & IDs
Public title
A Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Participants With Advanced Urothelial Cancer and Selected Fibroblast Growth Factor Receptor (FGFR) Gene Aberrations
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Scientific title
A Phase 3 Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Subjects With Advanced Urothelial Cancer and Selected FGFR Gene Aberrations
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Secondary ID [1]
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2017-002932-18
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Secondary ID [2]
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CR108401
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Universal Trial Number (UTN)
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Trial acronym
THOR
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Urothelial Cancer
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Condition category
Condition code
Intervention/exposure
Study type
Interventional(has expanded access)
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Description of intervention(s) / exposure
Treatment: Drugs - Erdafitinib
Treatment: Drugs - Vinflunine
Treatment: Drugs - Docetaxel
Treatment: Drugs - Pembrolizumab
Treatment: Devices - Fibroblast Growth Factor Receptor inhibitor Clinical Trial Assay (FGFRi CTA)
Experimental: Cohort 1 (Arm 1A): Erdafitinib - Participants will be screened based on Fibroblast Growth Factor Receptor Inhibitor Clinical Trial Assay (FGFRi CTA) to determine molecular eligibility and participants who meet molecular eligibility criteria will be eligible for full study screening. Participants enrolled in the study (treated with prior anti-programmed cell death protein PD-\[L\] 1 agent) will swallow erdafitinib tablets orally at a starting dose of 8 milligram (mg), once daily for 21 days in a 21-day cycle until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustment are based on phosphate level and observed toxicity (adverse events \[AEs\]). Participants who enter in Long-term extension (LTE) phase will continue to receive the erdafitinib tablet as per investigator's decision.
Experimental: Cohort 1 (Arm 1B): Vinflunine or Docetaxel - Participants will be screened based on FGFRi CTA to determine molecular eligibility and participants who meet molecular eligibility criteria will be eligible for full study screening. Participants enrolled in the study (treated with prior anti-PD-\[L\] 1 agent) will receive vinflunine 320 milligram per meter square (mg/m\^2) as a 20-minute intravenous infusion once every 3 weeks or docetaxel 75 mg/m\^2 as a 1 hour intravenous infusion every 3 weeks. Treatment with either agent (choice of investigator) will be administered until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustments are based on observed toxicities. Participants who enter in LTE phase will continue to receive Vinflunine or Docetaxel until the participant can commercially receive chemotherapy within the local healthcare system.
Experimental: Cohort 2 (Arm 2A): Erdafitinib - Participants will be screened based on FGFRi CTA to determine molecular eligibility and participants who meet molecular eligibility criteria will be eligible for full study screening. Participants enrolled in the study (no prior treatment with anti-PD-\[L\] 1 agent) will swallow erdafitinib tablets orally at a starting dose of 8 mg, once daily for 21 days in a 21-day cycle until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustments are based on phosphate level and observed toxicity (AEs). Participants who enter in LTE phase will continue to receive the erdafitinib tablet as per investigator's decision.
Experimental: Cohort 2 (Arm 2B): Pembrolizumab - Participants will be screened based on FGFRi CTA to determine molecular eligibility and participants who meet molecular eligibility criteria will be eligible for full study screening. Participants enrolled in the study (no prior treatment with anti-PD-\[L\] 1 agent) will receive pembrolizumab 200 mg as a 30-minute intravenous infusion once every 3 weeks, until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustments are based on observed toxicities. Participants who enter in LTE phase will continue to receive the pembrolizumab until 2 years after the first dose of pembrolizumab (at start of study) or until the participant can commercially receive pembrolizumab within the local healthcare system, whichever comes first.
Treatment: Drugs: Erdafitinib
Participants will swallow erdafitinib tablets orally at a starting dose of 8 mg.
Treatment: Drugs: Vinflunine
Participants will receive vinflunine 320 mg/m\^2 as a 20-minute intravenous infusion.
Treatment: Drugs: Docetaxel
Participants will receive docetaxel 75 mg/m\^2 as a 1 hour intravenous infusion.
Treatment: Drugs: Pembrolizumab
Participants will receive pembrolizumab 200 mg as a 30-minute intravenous infusion.
Treatment: Devices: Fibroblast Growth Factor Receptor inhibitor Clinical Trial Assay (FGFRi CTA)
FGFRi CTA will be used to determine molecular eligibility.
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Treatment: Devices
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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 Survival (OS)
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Assessment method [1]
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Overall survival is measured from the date of randomization to the date of the participant's death. If the participant is alive or the vital status is unknown, the participant will be censored at the date the participant was last known to be alive.
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Timepoint [1]
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Date of first randomization to the date of participant's death (approximately up to 3 years)
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Secondary outcome [1]
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Progression-free Survival (PFS)
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Assessment method [1]
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PFS is defined as duration in days from date of randomization to disease progression date (assessed per Response Evaluation Criteria in Solid Tumors Version 1.1 \[RECIST v1.1\] by investigator) or relapse from CR or death, whichever is reported first. RECIST 1.1, progressive disease is defined as a 20 percent (%) increase in the sum of diameters of all target lesions and a minimum absolute increase of 5 millimeter (mm) in the sum. CR is defined as disappearance of all target lesions, non-target lesions and normalization of tumor marker level.
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Timepoint [1]
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Date of randomization to the date of disease progression or relapse from complete response (CR) or death, whichever is reported first (approximately up to 3 years)
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Secondary outcome [2]
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Overall Response Rate (ORR)
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Assessment method [2]
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ORR is defined as the proportion of participants who achieve CR (CR; disappearance of all target lesions and disappearance of all non-target lesions and normalization of tumor marker level) or partial response (PR; at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters), as assessed per RECIST v1.1 by the investigator.
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Timepoint [2]
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Approximately up to 3 years
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Secondary outcome [3]
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Change from Baseline in Participant-Reported Health Status and Physical Functioning Scales of the Functional Assessment of Cancer Therapy (FACT-Bl)
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Assessment method [3]
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The FACT-Bl consists of 36 core items, with 5-point Likert response scales, covering 5 primary domains: Physical well-being, social/family well-being, emotional well-being, functional well-being, and bladder symptom subscale. The answer scales range from "Not at all (score=0)" to "very much (score=4)" to assess the meaningful significant symptom deterioration.
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Timepoint [3]
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Baseline up to end of treatment (approximately 3 years)
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Secondary outcome [4]
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Time Until Symptom Deterioration (Subset of FACT-BI Items)
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Assessment method [4]
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The FACT-Bl consists of 36 core items, with 5-point Likert response scales, covering 5 primary domains: Physical well-being, social/family well-being, emotional well-being, functional well-being, and bladder symptom subscale. The answer scales range from "Not at all (score=0)" to "very much (score=4)" to assess the meaningful significant symptom deterioration.
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Timepoint [4]
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Baseline up to end of treatment (approximately 3 years)
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Secondary outcome [5]
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Change from Baseline in Patient-Global Impression of Severity (PGIS) Score
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Assessment method [5]
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The PGIS is a single question regarding the participant report of disease severity. Participants will be asked that ''considering all aspects of your bladder cancer symptoms right now, would you say your bladder cancer symptoms are none, mild, moderate, severe, or very severe?" The PGIS is an anchor question that will be used to establish the magnitude of meaningful change in this study by assessing disease severity.
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Timepoint [5]
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Baseline up to end of treatment (approximately 3 years)
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Secondary outcome [6]
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Change from Baseline in the Visual Analog Scale (VAS) of the EQ-5D-5L
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Assessment method [6]
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European Quality of Life 5 Dimensions (EQ-5D) visual analog scale (VAS) is a 20 centimeter (cm) vertical VAS with scores ranging from 0 (worst imaginable health) to 100 (perfect health). A higher score indicates an improvement in health in the Health Status Index.
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Timepoint [6]
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Baseline up to follow up phase (approximately 3 years)
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Secondary outcome [7]
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Change from Baseline in the Utility Scale of the EQ-5D-5L
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Assessment method [7]
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The EuroQol-5 is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating "full health" and 0 representing dead.
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Timepoint [7]
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Baseline up to follow up phase (approximately 3 years)
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Secondary outcome [8]
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Duration of Response (DOR)
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Assessment method [8]
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DOR for responders is defined as duration in days from the date of initial documentation of a response to the date of first documented evidence of progressive disease (PD) or relapse for participants who experience CR (CR; disappearance of all target lesions and disappearance of all non-target lesions and normalization of tumor marker level) during the study or death.
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Timepoint [8]
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From the date of initial documentation of a response to date of first documented evidence of progressive disease (or participants relapse who experience CR during the study) or death (approximately up to 3 years)
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Secondary outcome [9]
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Number of Participants with Adverse Events (AEs) as a Measure of Safety
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Assessment method [9]
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An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
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Timepoint [9]
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Approximately up to 3 years
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Secondary outcome [10]
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Oral Clearance (CL/F) of Erdafitinib
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Assessment method [10]
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CL/F is the oral clearance; that is clearance based on oral bioavailability of erdafitinib.
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Timepoint [10]
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Day 14 (Cycle 1), Day 1 (Cycle 2) (each cycle is of 21 days)
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Secondary outcome [11]
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Area Under the Plasma Concentration-Time Curve from Time Zero to Time 't' (AUC[0-t]) of Erdafitinib
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Assessment method [11]
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AUC(0-t) is the area under the plasma concentration-time curve from time zero to any time 't' of erdafitinib.
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Timepoint [11]
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Day 14 (Cycle 1), Day 1 (Cycle 2) (each cycle is of 21 days)
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Eligibility
Key inclusion criteria
* Histologic demonstration of transitional cell carcinoma of the urothelium. Minor components ( less than [<] 50 percent [%] overall) of variant histology such as glandular or squamous differentiation, or evolution to more aggressive phenotypes such as sarcomatoid or micropapillary change are acceptable
* Metastatic or surgically unresectable urothelial cancer
* Documented progression of disease, defined as any progression that requires a change in treatment, prior to randomization
* Cohort 1: Prior treatment with an anti-PD-(L) 1 agent as monotherapy or as combination therapy; no more than 2 prior lines of systemic treatment. Cohort 2: No prior treatment with an anti-PD-(L) 1 agent; only 1 line of prior systemic treatment. Subjects who received neoadjuvant or adjuvant chemotherapy and showed disease progression within 12 months of the last dose are considered to have received systemic therapy in the metastatic setting.
* A woman of childbearing potential who is sexually active must have a negative pregnancy test (beta human chorionic gonadotropin [beta hCG]) at Screening (urine or serum)
* Participants must meet appropriate molecular eligibility criteria
* Eastern Cooperative Oncology Group (ECOG) performance status Grade 0, 1, or 2
* Adequate bone marrow, liver, and renal function
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Minimum age
18
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
* Treatment with any other investigational agent or participation in another clinical study with therapeutic intent within 30 days prior to randomization
* Active malignancies (that is, requiring treatment change in the last 24 months). The only allowed exceptions are: urothelial cancer, skin cancer treated within the last 24 months that is considered completely cured, localized prostate cancer with a gleason score of 6 (treated within the last 24 months or untreated and under surveillance) and localized prostate cancer with a gleason score of 3+4 that has been treated more than 6 months prior to full study screening and considered to have a very low risk of recurrence.
* Symptomatic central nervous system metastases
* Received prior fibroblast growth factor receptor (FGFR) inhibitor treatment
* Known allergies, hypersensitivity, or intolerance to erdafitinib or its excipients
* Current central serous retinopathy (CSR) or retinal pigment epithelial detachment of any grade.
* History of uncontrolled cardiovascular disease
* Impaired wound healing capacity defined as skin/decubitus ulcers, chronic leg ulcers, known gastric ulcers, or unhealed incisions
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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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
Parallel
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Other design features
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Phase
Phase 3
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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
23/03/2018
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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
1/11/2026
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Actual
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Sample size
Target
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Accrual to date
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Final
629
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Chris O'Brien Lifehouse - Camperdown
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Recruitment hospital [2]
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Peninsula & South Eastern Haematology and Oncology Group - Frankston
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Recruitment hospital [3]
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St George Hospital - Kogarah
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Recruitment hospital [4]
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Peter MacCallum Cancer Centre - Melbourne
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Recruitment hospital [5]
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Frankston Hospital - Melbourne
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Recruitment hospital [6]
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Fiona Stanley Hospital - Murdoch
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Recruitment postcode(s) [1]
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2050 - Camperdown
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Recruitment postcode(s) [2]
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3199 - Frankston
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2217 - Kogarah
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Recruitment postcode(s) [4]
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3000 - Melbourne
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Recruitment postcode(s) [5]
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3199 - Melbourne
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Recruitment postcode(s) [6]
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6150 - Murdoch
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Recruitment outside Australia
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Alaska
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Illinois
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France
Query!
State/province [78]
0
0
Clermont Ferrand
Query!
Country [79]
0
0
France
Query!
State/province [79]
0
0
Dijon
Query!
Country [80]
0
0
France
Query!
State/province [80]
0
0
Lille
Query!
Country [81]
0
0
France
Query!
State/province [81]
0
0
Lorient
Query!
Country [82]
0
0
France
Query!
State/province [82]
0
0
Marseille
Query!
Country [83]
0
0
France
Query!
State/province [83]
0
0
Montpellier
Query!
Country [84]
0
0
France
Query!
State/province [84]
0
0
Nice
Query!
Country [85]
0
0
France
Query!
State/province [85]
0
0
Nîmes
Query!
Country [86]
0
0
France
Query!
State/province [86]
0
0
Paris Cedex 10
Query!
Country [87]
0
0
France
Query!
State/province [87]
0
0
Paris
Query!
Country [88]
0
0
France
Query!
State/province [88]
0
0
Pierre-Bénite
Query!
Country [89]
0
0
France
Query!
State/province [89]
0
0
Poitiers Cedex
Query!
Country [90]
0
0
France
Query!
State/province [90]
0
0
Rennes Cedex
Query!
Country [91]
0
0
France
Query!
State/province [91]
0
0
Ris Orangis
Query!
Country [92]
0
0
France
Query!
State/province [92]
0
0
Saint-Priest-en-Jarez
Query!
Country [93]
0
0
France
Query!
State/province [93]
0
0
Strasbourg Cedex
Query!
Country [94]
0
0
France
Query!
State/province [94]
0
0
Toulouse
Query!
Country [95]
0
0
France
Query!
State/province [95]
0
0
Valenciennes
Query!
Country [96]
0
0
France
Query!
State/province [96]
0
0
Villejuif
Query!
Country [97]
0
0
Germany
Query!
State/province [97]
0
0
Berlin
Query!
Country [98]
0
0
Germany
Query!
State/province [98]
0
0
Braunschweig
Query!
Country [99]
0
0
Germany
Query!
State/province [99]
0
0
Dresden
Query!
Country [100]
0
0
Germany
Query!
State/province [100]
0
0
Duesseldorf
Query!
Country [101]
0
0
Germany
Query!
State/province [101]
0
0
Erlangen
Query!
Country [102]
0
0
Germany
Query!
State/province [102]
0
0
Frankfurt
Query!
Country [103]
0
0
Germany
Query!
State/province [103]
0
0
Freiburg
Query!
Country [104]
0
0
Germany
Query!
State/province [104]
0
0
Greifswald
Query!
Country [105]
0
0
Germany
Query!
State/province [105]
0
0
Göttingen
Query!
Country [106]
0
0
Germany
Query!
State/province [106]
0
0
Hamburg
Query!
Country [107]
0
0
Germany
Query!
State/province [107]
0
0
Hannover
Query!
Country [108]
0
0
Germany
Query!
State/province [108]
0
0
Lubeck
Query!
Country [109]
0
0
Germany
Query!
State/province [109]
0
0
Mannheim
Query!
Country [110]
0
0
Germany
Query!
State/province [110]
0
0
Muenster
Query!
Country [111]
0
0
Germany
Query!
State/province [111]
0
0
Nuertingen
Query!
Country [112]
0
0
Germany
Query!
State/province [112]
0
0
Regensburg
Query!
Country [113]
0
0
Germany
Query!
State/province [113]
0
0
Rostock
Query!
Country [114]
0
0
Germany
Query!
State/province [114]
0
0
Velbert
Query!
Country [115]
0
0
Germany
Query!
State/province [115]
0
0
Weiden
Query!
Country [116]
0
0
Greece
Query!
State/province [116]
0
0
Athens
Query!
Country [117]
0
0
Greece
Query!
State/province [117]
0
0
Athina
Query!
Country [118]
0
0
Greece
Query!
State/province [118]
0
0
Larisa
Query!
Country [119]
0
0
Greece
Query!
State/province [119]
0
0
Patras
Query!
Country [120]
0
0
Greece
Query!
State/province [120]
0
0
Thessaloniki
Query!
Country [121]
0
0
Hungary
Query!
State/province [121]
0
0
Budapest
Query!
Country [122]
0
0
Hungary
Query!
State/province [122]
0
0
Nyíregyháza
Query!
Country [123]
0
0
Hungary
Query!
State/province [123]
0
0
Pécs
Query!
Country [124]
0
0
Israel
Query!
State/province [124]
0
0
Haifa
Query!
Country [125]
0
0
Israel
Query!
State/province [125]
0
0
Jerusalem
Query!
Country [126]
0
0
Israel
Query!
State/province [126]
0
0
Kfar Saba
Query!
Country [127]
0
0
Israel
Query!
State/province [127]
0
0
Petach Tikvah
Query!
Country [128]
0
0
Israel
Query!
State/province [128]
0
0
Tel Aviv
Query!
Country [129]
0
0
Israel
Query!
State/province [129]
0
0
Tel Hashomer
Query!
Country [130]
0
0
Israel
Query!
State/province [130]
0
0
Tzrifin
Query!
Country [131]
0
0
Italy
Query!
State/province [131]
0
0
Alessandria
Query!
Country [132]
0
0
Italy
Query!
State/province [132]
0
0
Arezzo
Query!
Country [133]
0
0
Italy
Query!
State/province [133]
0
0
Aviano
Query!
Country [134]
0
0
Italy
Query!
State/province [134]
0
0
Bergamo
Query!
Country [135]
0
0
Italy
Query!
State/province [135]
0
0
Brescia
Query!
Country [136]
0
0
Italy
Query!
State/province [136]
0
0
Cremona
Query!
Country [137]
0
0
Italy
Query!
State/province [137]
0
0
Firenze
Query!
Country [138]
0
0
Italy
Query!
State/province [138]
0
0
Genova
Query!
Country [139]
0
0
Italy
Query!
State/province [139]
0
0
Macerata
Query!
Country [140]
0
0
Italy
Query!
State/province [140]
0
0
Meldola
Query!
Country [141]
0
0
Italy
Query!
State/province [141]
0
0
Milano
Query!
Country [142]
0
0
Italy
Query!
State/province [142]
0
0
Milan
Query!
Country [143]
0
0
Italy
Query!
State/province [143]
0
0
Modena
Query!
Country [144]
0
0
Italy
Query!
State/province [144]
0
0
Napoli
Query!
Country [145]
0
0
Italy
Query!
State/province [145]
0
0
Novara
Query!
Country [146]
0
0
Italy
Query!
State/province [146]
0
0
Orbassano
Query!
Country [147]
0
0
Italy
Query!
State/province [147]
0
0
Padova
Query!
Country [148]
0
0
Italy
Query!
State/province [148]
0
0
Parma
Query!
Country [149]
0
0
Italy
Query!
State/province [149]
0
0
Pavia
Query!
Country [150]
0
0
Italy
Query!
State/province [150]
0
0
Pisa
Query!
Country [151]
0
0
Italy
Query!
State/province [151]
0
0
Poggibonsi (SI)
Query!
Country [152]
0
0
Italy
Query!
State/province [152]
0
0
Roma
Query!
Country [153]
0
0
Italy
Query!
State/province [153]
0
0
Siena
Query!
Country [154]
0
0
Italy
Query!
State/province [154]
0
0
Torino
Query!
Country [155]
0
0
Italy
Query!
State/province [155]
0
0
Torrette Di Ancona
Query!
Country [156]
0
0
Japan
Query!
State/province [156]
0
0
Chiba
Query!
Country [157]
0
0
Japan
Query!
State/province [157]
0
0
Hirosaki
Query!
Country [158]
0
0
Japan
Query!
State/province [158]
0
0
Kashiwa
Query!
Country [159]
0
0
Japan
Query!
State/province [159]
0
0
Kita-Gun
Query!
Country [160]
0
0
Japan
Query!
State/province [160]
0
0
Kobe
Query!
Country [161]
0
0
Japan
Query!
State/province [161]
0
0
Koshigaya
Query!
Country [162]
0
0
Japan
Query!
State/province [162]
0
0
Matsuyama
Query!
Country [163]
0
0
Japan
Query!
State/province [163]
0
0
Miyazaki
Query!
Country [164]
0
0
Japan
Query!
State/province [164]
0
0
Nagano
Query!
Country [165]
0
0
Japan
Query!
State/province [165]
0
0
Nagoya Shi
Query!
Country [166]
0
0
Japan
Query!
State/province [166]
0
0
Osaka City
Query!
Country [167]
0
0
Japan
Query!
State/province [167]
0
0
Osaka-Sayama
Query!
Country [168]
0
0
Japan
Query!
State/province [168]
0
0
Osaka
Query!
Country [169]
0
0
Japan
Query!
State/province [169]
0
0
Ota
Query!
Country [170]
0
0
Japan
Query!
State/province [170]
0
0
Sagamihara
Query!
Country [171]
0
0
Japan
Query!
State/province [171]
0
0
Sakura
Query!
Country [172]
0
0
Japan
Query!
State/province [172]
0
0
Sapporo
Query!
Country [173]
0
0
Japan
Query!
State/province [173]
0
0
Shinjuku-ku
Query!
Country [174]
0
0
Japan
Query!
State/province [174]
0
0
Tokyo
Query!
Country [175]
0
0
Japan
Query!
State/province [175]
0
0
Tsukuba
Query!
Country [176]
0
0
Japan
Query!
State/province [176]
0
0
Ube
Query!
Country [177]
0
0
Japan
Query!
State/province [177]
0
0
Yokohama
Query!
Country [178]
0
0
Korea, Republic of
Query!
State/province [178]
0
0
Busan
Query!
Country [179]
0
0
Korea, Republic of
Query!
State/province [179]
0
0
Daejeon
Query!
Country [180]
0
0
Korea, Republic of
Query!
State/province [180]
0
0
Goyangsi
Query!
Country [181]
0
0
Korea, Republic of
Query!
State/province [181]
0
0
Gwangju
Query!
Country [182]
0
0
Korea, Republic of
Query!
State/province [182]
0
0
Gyeonggi-do
Query!
Country [183]
0
0
Korea, Republic of
Query!
State/province [183]
0
0
Incheon
Query!
Country [184]
0
0
Korea, Republic of
Query!
State/province [184]
0
0
Seoul
Query!
Country [185]
0
0
Korea, Republic of
Query!
State/province [185]
0
0
Wonju-si
Query!
Country [186]
0
0
Mexico
Query!
State/province [186]
0
0
Aguascalientes
Query!
Country [187]
0
0
Mexico
Query!
State/province [187]
0
0
Chihuahua
Query!
Country [188]
0
0
Mexico
Query!
State/province [188]
0
0
Naucalpan
Query!
Country [189]
0
0
Netherlands
Query!
State/province [189]
0
0
Amsterdam
Query!
Country [190]
0
0
Netherlands
Query!
State/province [190]
0
0
Den Haag
Query!
Country [191]
0
0
Netherlands
Query!
State/province [191]
0
0
Nieuwegein
Query!
Country [192]
0
0
Poland
Query!
State/province [192]
0
0
Bydgoszcz
Query!
Country [193]
0
0
Poland
Query!
State/province [193]
0
0
Warszawa
Query!
Country [194]
0
0
Poland
Query!
State/province [194]
0
0
Wroclaw
Query!
Country [195]
0
0
Portugal
Query!
State/province [195]
0
0
Lisboa
Query!
Country [196]
0
0
Portugal
Query!
State/province [196]
0
0
Lisbon
Query!
Country [197]
0
0
Portugal
Query!
State/province [197]
0
0
Porto
Query!
Country [198]
0
0
Russian Federation
Query!
State/province [198]
0
0
Barnaul
Query!
Country [199]
0
0
Russian Federation
Query!
State/province [199]
0
0
Chelyabinsk
Query!
Country [200]
0
0
Russian Federation
Query!
State/province [200]
0
0
Irkutsk
Query!
Country [201]
0
0
Russian Federation
Query!
State/province [201]
0
0
Ivanovo
Query!
Country [202]
0
0
Russian Federation
Query!
State/province [202]
0
0
Kostroma
Query!
Country [203]
0
0
Russian Federation
Query!
State/province [203]
0
0
Kuzmolovsky
Query!
Country [204]
0
0
Russian Federation
Query!
State/province [204]
0
0
Moscow
Query!
Country [205]
0
0
Russian Federation
Query!
State/province [205]
0
0
Nalchik
Query!
Country [206]
0
0
Russian Federation
Query!
State/province [206]
0
0
Nizhni Novgorod
Query!
Country [207]
0
0
Russian Federation
Query!
State/province [207]
0
0
Omsk
Query!
Country [208]
0
0
Russian Federation
Query!
State/province [208]
0
0
Pyatigorsk
Query!
Country [209]
0
0
Russian Federation
Query!
State/province [209]
0
0
Saint Petersburg
Query!
Country [210]
0
0
Russian Federation
Query!
State/province [210]
0
0
Saint-Petersburg
Query!
Country [211]
0
0
Russian Federation
Query!
State/province [211]
0
0
Saransk
Query!
Country [212]
0
0
Russian Federation
Query!
State/province [212]
0
0
Saratov
Query!
Country [213]
0
0
Russian Federation
Query!
State/province [213]
0
0
Smolensk
Query!
Country [214]
0
0
Russian Federation
Query!
State/province [214]
0
0
Sochi
Query!
Country [215]
0
0
Russian Federation
Query!
State/province [215]
0
0
St. Petersburg
Query!
Country [216]
0
0
Russian Federation
Query!
State/province [216]
0
0
St.Petersburg
Query!
Country [217]
0
0
Russian Federation
Query!
State/province [217]
0
0
Tyumen
Query!
Country [218]
0
0
Russian Federation
Query!
State/province [218]
0
0
Ufa
Query!
Country [219]
0
0
Russian Federation
Query!
State/province [219]
0
0
Vologda
Query!
Country [220]
0
0
Spain
Query!
State/province [220]
0
0
Badajoz
Query!
Country [221]
0
0
Spain
Query!
State/province [221]
0
0
Badalona
Query!
Country [222]
0
0
Spain
Query!
State/province [222]
0
0
Barcelona
Query!
Country [223]
0
0
Spain
Query!
State/province [223]
0
0
Caceres
Query!
Country [224]
0
0
Spain
Query!
State/province [224]
0
0
Córdoba
Query!
Country [225]
0
0
Spain
Query!
State/province [225]
0
0
Granada
Query!
Country [226]
0
0
Spain
Query!
State/province [226]
0
0
Jaén
Query!
Country [227]
0
0
Spain
Query!
State/province [227]
0
0
Las Palmas de Gran Canaria
Query!
Country [228]
0
0
Spain
Query!
State/province [228]
0
0
Lugo
Query!
Country [229]
0
0
Spain
Query!
State/province [229]
0
0
Madrid
Query!
Country [230]
0
0
Spain
Query!
State/province [230]
0
0
Majadahonda
Query!
Country [231]
0
0
Spain
Query!
State/province [231]
0
0
Manresa
Query!
Country [232]
0
0
Spain
Query!
State/province [232]
0
0
Pamplona
Query!
Country [233]
0
0
Spain
Query!
State/province [233]
0
0
Sevilla
Query!
Country [234]
0
0
Spain
Query!
State/province [234]
0
0
Valencia
Query!
Country [235]
0
0
Spain
Query!
State/province [235]
0
0
Zaragoza
Query!
Country [236]
0
0
Taiwan
Query!
State/province [236]
0
0
Kaohsiung
Query!
Country [237]
0
0
Taiwan
Query!
State/province [237]
0
0
Niao-Sung Hsiang
Query!
Country [238]
0
0
Taiwan
Query!
State/province [238]
0
0
Taichung
Query!
Country [239]
0
0
Taiwan
Query!
State/province [239]
0
0
Tainan
Query!
Country [240]
0
0
Taiwan
Query!
State/province [240]
0
0
Taipei City
Query!
Country [241]
0
0
Taiwan
Query!
State/province [241]
0
0
Taipei
Query!
Country [242]
0
0
Taiwan
Query!
State/province [242]
0
0
Taoyuan
Query!
Country [243]
0
0
Turkey
Query!
State/province [243]
0
0
Adana
Query!
Country [244]
0
0
Turkey
Query!
State/province [244]
0
0
Ankara
Query!
Country [245]
0
0
Turkey
Query!
State/province [245]
0
0
Istanbul
Query!
Country [246]
0
0
Turkey
Query!
State/province [246]
0
0
Izmir
Query!
Country [247]
0
0
Turkey
Query!
State/province [247]
0
0
Kocaeli
Query!
Country [248]
0
0
Turkey
Query!
State/province [248]
0
0
Malatya
Query!
Country [249]
0
0
Ukraine
Query!
State/province [249]
0
0
Dnipropetrovsk
Query!
Country [250]
0
0
Ukraine
Query!
State/province [250]
0
0
Dnipro
Query!
Country [251]
0
0
Ukraine
Query!
State/province [251]
0
0
Ivano-Frankivsk
Query!
Country [252]
0
0
Ukraine
Query!
State/province [252]
0
0
Kharkiv
Query!
Country [253]
0
0
Ukraine
Query!
State/province [253]
0
0
Kyiv
Query!
Country [254]
0
0
Ukraine
Query!
State/province [254]
0
0
Lviv
Query!
Country [255]
0
0
Ukraine
Query!
State/province [255]
0
0
Uzhgorod
Query!
Country [256]
0
0
Ukraine
Query!
State/province [256]
0
0
Vinnitsa
Query!
Country [257]
0
0
Ukraine
Query!
State/province [257]
0
0
Zaporizhzhia
Query!
Country [258]
0
0
United Kingdom
Query!
State/province [258]
0
0
Bristol
Query!
Country [259]
0
0
United Kingdom
Query!
State/province [259]
0
0
London
Query!
Country [260]
0
0
United Kingdom
Query!
State/province [260]
0
0
Manchester
Query!
Country [261]
0
0
United Kingdom
Query!
State/province [261]
0
0
Plymouth
Query!
Country [262]
0
0
United Kingdom
Query!
State/province [262]
0
0
Sheffield
Query!
Country [263]
0
0
United Kingdom
Query!
State/province [263]
0
0
Southampton
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Country [264]
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United Kingdom
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Sutton
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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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Ethics approval
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Summary
Brief summary
The purpose of this study is to evaluate efficacy of erdafitinib versus chemotherapy or pembrolizumab in participants with advanced urothelial cancer harboring selected fibroblast growth factor receptor (FGFR) aberrations who have progressed after 1 or 2 prior treatments, at least 1 of which includes an anti-programmed death ligand 1(PD-\[L\]1) agent (cohort 1) or 1 prior treatment not containing an anti-PD-(L) 1 agent (cohort 2).
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Trial website
https://clinicaltrials.gov/study/NCT03390504
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Janssen Research & Development, LLC Clinical Trial
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Janssen Research & Development, LLC
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Contact person for public queries
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT03390504
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